In A Phase III Lipid Interim Analysis, ACAPODENE Treatment Lowered Cholesterol And Raised HDL In Prostate Cancer Patients On Androgen Deprivation

GTx, Inc. (Nasdaq: GTXI), the Men's Health Biotech Company, announced today the results of a lipid interim analysis of the pivotal Phase III ADT clinical trial evaluating oral, once daily ACAPODENE(R) (toremifene citrate) 80mg for the treatment of the multiple serious side effects of androgen deprivation therapy (ADT) in men with advanced prostate cancer.

The lipid interim analysis was performed in the first 197 subjects who completed one year of the trial. Prostate cancer patients on ADT who received ACAPODENE compared to placebo had lower total cholesterol (-7.1%; p=0.001), LDL (-9.0%; p=0.003), and triglyceride (-20.1%; p=0.009) levels, a reduction in the total cholesterol/HDL ratio (-11.7%; p<0.001), and higher HDL levels (+5.4%; p=0.018). Although patients who were also taking statins had further reduction of total cholesterol, the magnitude of these lipid changes was greater in patients who were not concomitantly taking statins. The final lipid data set will be evaluated before any conclusions may be made on the clinical significance of these findings.

"Androgen deprivation therapy is quite effective in turning prostate cancer into a chronic disease in many patients," said Matthew R. Smith, M.D., Ph.D., Associate Professor of Medicine, Harvard Medical School. Dr. Smith is the lead Principal Investigator of the Phase III ADT clinical trial. "As patients are living longer with prostate cancer because of ADT, serious side effects have become major causes of morbidity and even death. These serious ADT side effects include osteoporosis and fractures as well as adverse lipid changes and cardiovascular disease. A medicine that is able to address multiple side effects of ADT would mark important progress in the care of prostate cancer patients."

GTx is conducting a pivotal Phase III clinical trial of ACAPODENE for the treatment of multiple serious side effects of ADT in approximately 1,400 men at over 150 sites in the United States and Mexico. The primary endpoint of the trial is a reduction in vertebral fractures. Secondary endpoints include improvements in bone mineral density (BMD), hot flashes, gynecomastia, and lipid profiles. Final data from the trial, which is being conducted under a Special Protocol Assessment with the United States Food & Drug Administration, is expected in the second half of 2007.

In December 2005, GTx conducted an interim analysis of the bone loss that leads to fractures which is another serious side effect of ADT. BMD was measured in the first 197 patients to complete one year of treatment. The per protocol analysis revealed highly statistically significant increases in BMD in all three skeletal sites assessed in patients receiving ACAPODENE compared to placebo: lumbar spine (+2.3%; p<0.001); hip (+2.0%; p=0.001); and femoral neck (+1.5%; p=0.009). The magnitude of these positive changes in BMD provides increased confidence that ACAPODENE should show efficacy in the trial's primary endpoint, a 40% reduction in vertebral fractures at two years.

"ACAPODENE has demonstrated the potential to increase bone mineral density, and the lipid interim analysis suggests that ACAPODENE may lower cholesterol," said Mitchell S. Steiner, M.D., CEO of GTx. "We continue to be confident in the Phase III ADT clinical trial. If ACAPODENE can treat multiple serious side effects of ADT, it has the potential to become the mainstay of prostate cancer supportive care for patients on ADT."

About GTx

GTx, headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics for cancer and serious conditions related to men's health. GTx's lead drug discovery and development programs are focused on small molecules that selectively modulate the effects of estrogens and androgens, two essential classes of hormones. GTx is developing ACAPODENE(R) (toremifene citrate), a selective estrogen receptor modulator, or SERM, in two separate clinical programs in men: first, a pivotal Phase III clinical trial for the treatment of serious side effects of ADT for advanced prostate cancer, and second, a pivotal Phase III clinical trial for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia, or PIN. GTx also is developing ostarine, a selective androgen receptor modulator, or SARM, for a variety of indications including muscle wasting and bone loss in frail elderly patients, osteoporosis, muscle wasting in end stage renal disease patients, and severe burn wounds and associated muscle wasting. GTx has licensed to Ortho Biotech Products, L.P., a subsidiary of Johnson & Johnson, another of its SARMs, andarine, under a joint collaboration and license agreement.

Forward-Looking Information is Subject to Risk and Uncertainty This press release contains forward-looking statements based upon GTx's current expectations. Forward-looking statements involve risks and uncertainties. GTx's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risks that (i) GTx will not be able to commercialize its product candidates if clinical trials do not demonstrate safety and efficacy in humans; (ii) GTx may not be able to obtain required regulatory approvals to commercialize its product candidates; (iii) GTx's clinical trials may not be completed on schedule, or at all, or may otherwise be suspended or terminated; and (iv) GTx could utilize its available cash resources sooner than it currently expects and may be unable to raise capital when needed, which would force GTx to delay, reduce or eliminate its product development programs or commercialization efforts. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. GTx's Quarterly Report on Form 10-Q filed on May 5, 2006 contains a more comprehensive description of these and other risks to which GTx is subject. GTx expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

GTx, Inc.
http://www.gtxinc.com

New Test Detects Prostate Cancer Spread At The Earliest Time

A new prognostic test can help determine whether a prostate cancer patient will go on to have a recurrence of the disease, even if surrounding lymph nodes initially appear negative for cancer, according to a study by University of Southern California researchers.

The test, developed at USC, "appears to be a very powerful test and better than anything else we know of for predicting recurrence," says Richard Cote, professor of pathology and urology at the Keck School of Medicine of USC. Current trials are also using the test to find hidden metastases in lymph nodes and bone marrow for breast and lung cancers.

The study, "Detection of Occult Lymph Node Metastases in Patients with Local Advanced (pT3) Node-Negative Prostate Cancer" appears this week in the Journal of Clinical Oncology.

Prostate cancer is the most common non-skin cancer in America, according to the Prostate Cancer Foundation. One in six American men will be diagnosed with prostate cancer, making men 35 percent more likely to be diagnosed with prostate cancer than women are to be diagnosed with breast cancer.

"Thanks to greater awareness, as well as increased and improved screening, we see men increasingly diagnosed with prostate cancer in its early stages," Cote says. "Most of these patients will do very well and will not require treatment beyond surgery or radiation therapy to cure their disease."

But a proportion of these patients have metastases of the prostate cancer appear later, even when the lymph nodes removed at the time of the cancer surgery appeared negative for cancer, he says.

Cote and his colleagues looked at 3,914 lymph nodes from 180 patients who were staged as having lymph nodes negative for cancer based on standardized histologic evaluation (visual scan under a microscope). The lymph nodes were then evaluated for occult (hidden) metastases using new specific immunohistochemistry tests that can detect cancer on a cell-by-cell level.

Their new analysis checks for cells that react with antibodies to cytokeratins and PSA. The team's testing found occult tumor cells in the lymph nodes of 24 of the patients whose lymph nodes had been previously been diagnosed as cancer-free.

The test used to detect the occult tumor cells is more sensitive than any clinical, pathologic or radiographic techniques, Cote says.

The group then compared cancer recurrence and survival in those patients with the hidden tumor cells versus those without the cells. The presence of occult tumor cells was associated with increased prostate cancer recurrence and decreased survival. In fact, "the outcome for patients with occult tumor cells was similar to those who were identified as having positive lymph nodes at the time of the surgery," Cote says.

"We have shown that occult tumor spread in lymph nodes is a significant predictor of disease recurrence," he says. "Once surgery is performed, the primary form of treatment is adjuvant systemic therapy. In patients with no evidence of metastasis, success of such therapy is assumed to be due to killing of occult tumor before it becomes clinically evident. Therefore, the ability to detect occult metastasis is pivotal to identification of patients who would most benefit from systemic therapy and also identify patients who may be spared from unnecessary therapy."

###

Vincenzo Pagliarulo, Debra Hawkes, Frank Brands, Susan Groshen, Jie Cai, John P. Stein, Gary Lieskovsky, Donald G. Skinner, Richard J. Cote, "Detection of Occult Lymph Node Metastases in Patients with Locally Advanced (pT3) Node Negative Prostate Cancer," Journal of Clinical Oncology, 24: 2735-2741, 2006.

Contact: Jon Weiner

University of Southern California

Urologist Plays Key Role In Determining Use Of Hormone Therapy In Prostate Cancer

The urologist a patient sees may be a more important factor than the tumor characteristics or the patient's other characteristics in determining the use of hormonal therapy for prostate cancer, a new study reports in the June 21 issue of the Journal of the National Cancer Institute.

Androgen deprivation therapy, which blocks steroid hormones called androgens, is used in around 50% of prostate cancer patients. It is recommended for locally advanced and metastatic prostate cancer. Because the therapy is expensive and potentially toxic, it is important to understand the factors responsible for its use.

Vahakn B. Shahinian, M.D., from the University of Texas Medical Branch in Galveston, and colleagues analyzed data from 61,717 men in the Surveillance, Epidemiology, and End Results (SEER) -- Medicare database who were diagnosed with prostate cancer at age 65 years or older and from their 1,802 urologists. The scientists assessed the pattern of androgen therapy use within 6 months of diagnosis to determine the part attributable to the urologist versus patient and tumor characteristics.

The authors found that the use of androgen deprivation therapy for prostate cancer was more dependent on the urologist who treated the patient than characteristics of the tumor or patient. They report that 21% of variance in the use of androgen deprivation therapy could be attributed to the urologist, versus 9.7% to tumor characteristics (stage or grade), and 4.3% to patient characteristics.

The authors write, "The substantial variance in use of androgen deprivation therapy attributable to the urologist, independent of patient factors, suggest that interventions at the level of the urologist may be an effective way to modify the use of this therapy for prostate cancer."

In an accompanying editorial, Paul F. Schellhammer, M.D., of Eastern Virginia Medical School in Norfolk, Va., discusses the challenges of using androgen deprivation for prostate cancer therapy. He writes, "The challenge for urologists is to offer men with high-risk, potentially lethal prostate cancer androgen deprivation therapy early in their course of treatment and to avoid the unnecessary risks of androgen deprivation therapy among men with low-risk indolent disease."

###

Contacts:

* Article: Vahakn B. Shahinian, vbshahin@utmb.edu
* Editorial: Paul F. Schellhammer, schellpf@evms.edu

Citations:

* Article: Shahinian VB, Kuo Y-F, Freeman JL, Goodwin JS. Determinants of Androgen Deprivation Therapy Use for Prostate Cancer: Role of the Urologist. J Natl Cancer Inst 2006; 98: 839-845.
* Editorial: Schellhammer PF. Timing of Androgen Deprivation Therapy: Some Questions Answered, Others Not. J Natl Cancer Inst 2006; 98:802-803.

Note: The Journal of the National Cancer Institute is published by Oxford University Press and is not affiliated with the National Cancer Institute. Attribution to the Journal of the National Cancer Institute is requested in all news coverage. Visit the Journal online at http://jncicancerspectrum.oxfordjournals.org/

Contact: Ariel Whitworth

Journal of the National Cancer Institute

Dutasteride Induces Apoptosis In Androgen Sensitive Prostate Cancer Cell Lines

UroToday.com - Dr. McCrohan as research colleagues from University College Dublin report that the dual 5 a-reductase inhibitor dutasteride induces apoptosis in androgen sensitive, but not androgen insensitive prostate cancer (CaP) cell lines and primary cultures. Their work appears in the epub version of Cancer.

The administration of dutasteride (0.1-10mM) resulted in apoptosis in androgen sensitive LNCaP, pwR-1E, PNT-2 and PC3 (AR) cells. Apoptosis was assessed by quantification of cells with hypodiploid DNA by propidium iodide incorporation. LNCaP and PC3 (AR) cells remained responsive to treatment to 4 and 5 days, respectively. Androgen insensitive PC3 cells did not respond to dutasteride.

In first passage CaP primary cultures, dutasteride induced apoptosis in 7 samples, but not in 9 samples. The difference could not be explained by differences in dutasteride on cell cycle progression or expression of 5 a-reductase isoforms.

The Reduction by Dutasteride of Prostate Cancer Events study is testing dutasteride as chemoprevention and this basic science work adds to the understanding of dutasteride mechanism. It also provides rationale for use of dutasteride in combination with intermittent androgen deprivation therapy, now being tested in clinical trials.

By Christopher P. Evans, MD
Reference:
Cancer. 2006 Jun 15;106(12):2743-52
Link Here.
Maria McCrohan A, Morrissey C, O'keane C, Mulligan N, Watson C, Smith J, Fitzpatrick JM, Watson RW

UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to:
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Copyright © 2006 - UroToday

High Surgeon Radical Prostatectomy Volume Is Linked To Lower Hospital Charges

UroToday.com - Increased procedure volume by both surgeon and hospital are associated with decreased mortality. In the on-line version of European Urology, 2006 Dr. Ramirez and colleagues report that increased surgeon radical prostatectomy (RP) volume is associated with decreased hospital charges.

Using the State of Florida Inpatient Discharge Information Data File, 3,167 RPs were identified between January and December 1998. The average patient age was 63.5 years and 77% of patients were Caucasian. Of note, in 1997 the average surgical volume for RPs was 18.

Hospital charges ranged from $4,755 to $140,201 with a mean of $18,200. SV ranged from 2 to 162 with a mean of 68 RPs. The multivariate regression indicated that a SV increase corresponding to one RP is linked with a $25 decrease in hospital charges.

Application of this observation to a theoretical cohort of 1,000 patients suggests that one surgeon performing 50 RPs annually versus one performing 10 RPs results in $1,000 of increased hospital charges. This would correspond to a savings of $1,000,000 if applied to 1,000 patients.

Using the 1997 SV average of 18, 1,000 RPs performed by 10 surgeons with an annual volume of 200 instead of 18 would result in decreased charges of $4,550,000.

This study is limited by selection bias in the patient sample and does not include the variable of hospital volume. In addition, charges do not necessarily reflect true savings.

By Christopher P. Evans, MD

Reference:
Eur Urol. 2006 Jul;50(1):58-63. Epub 2006 Mar 27.
Link Here.
Ramirez A, Benayoun S, Briganti A, Chun J, Perrotte P, Kattan MW, Graefen M, McCormack M, Neugut AI, Saad F, Karakiewicz PI

UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to:
http://www.urotoday.com

Copyright © 2006 - UroToday

Shift In Prostate Cancer Gleason Grades From 1989 To 2001

UroToday.com - Since the clinical introduction of PSA testing, there is reason to hypothesize that prostate cancer (CaP) Gleason grades may have shifted due to a variety of factors. Dr. Sengupta and associates at the Mayo Clinic report this to be the case in the epub version of Cancer.

Between 1989 and 2001, 8750 patients who underwent radical prostatectomy at the Mayo clinic met the study criteria. Gleason grades over the 13 year period were reviewed and biochemical recurrence (defined as a PSA >0.4ng/ml) was recorded. Biochemical recurrence-free survival (BRFS) was estimated using Kaplan Meier methodology.

The percentage of RP specimens assigned a Gleason grade of 3 as either the primary or secondary grade increased from 86% vs. 49% for primary and 71% vs. 47% for secondary pattern for 1999-2001 vs. 1989-1999, respectively. During the same time periods, the prevalence of Gleason grade 2 tumors decreased from 0.4% vs. 38% for primary and 1.3% vs. 28% for secondary Gleason grade patterns. As a result, less Gleason score 4-5 tumors and more Gleason score 6-7 tumors were identified.

The BRFS for patients with Gleason score 6 and 7 tumors improved over the time periods. For Gleason score 6 the 5-year BRFS improved form 47% to 87% over the two time periods. For Gleason score 7 the 5-year BRFS improved form 51% to 66% over the two time periods. There were no significant changes noted over the same time periods for Gleason scores 2-4 or 8-10. In multivariate analysis, improved BRFS remained for Gleason score 6, but not for patients with Gleason score 7 tumors.

The noted Gleason grade shifts may be a result of true stage migration secondary to PSA screening or changes in pathologic interpretation over the time period studied.

By Christopher P. Evans, MD

Reference: Cancer. 2006 Jun 15;106(12):2630-5.

Link Here.

Sengupta S, Slezak JM, Blute ML, Leibovich BC, Sebo TJ, Myers RP, Cheville JC, Bergstralh EJ, Zincke H. UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to:
http://www.urotoday.com

Copyright © 2006 - UroToday

Obesity Undermines Radiation Treatment For Prostate Cancer

Obese men do not benefit from radiation treatment for prostate cancer as much as men who are not obese, say researchers from the University of Texas M.D. Anderson Cancer Center, Houston. This could help doctors decide how aggressive certain people's treatment should be.

Prof. Sara Strom, lead author, said "Prostate cancer for most men is quiet. It's a cancer with a good outcome. Basically, what you would like in prostate cancer is to identify men who have more chances of having a bad outcome, so you can do something different with them. Obesity is something to take into consideration."

You can read about this report in the journal Cancer, August 1.

However, some experts have questioned the validity of the report for two reasons:

1. The study refers to treatment carried out between 1998-2001. New radiation technologies have changed since then.
2. The number of obese men is the study was small.

Several studies have indicated that obesity is a complicating factor in many different cancers and their treatment outcomes. Men who are obese and get prostate cancer are more likely to suffer from the more aggressive forms. Prostate cancer patients who are obese have a much higher probability of having to have either the whole prostate or parts of it surgically removed (prostatectomy).

This is the first study to specifically look at how obesity may affect prostate cancer progression after radiation treatment. Prof. Storm and team looked at the medical records of 873 men who had prostate cancer - they had only received external beam radiotherapy for their disease. 5% of the men were either moderately or severely obese while 18% were mildly obese.

The researchers found a clear correlation between prostate cancer progression and the patients' body mass index (BMI). The higher a patient's BMI, the higher the likelihood of metastasis or tumor recurrence. They also found that the 5% who were moderately to severely obese were 99% more likely to have high levels of prostate-specific antigen.

Storm said that they found that after taking all other important risk factor for a bad outcome into consideration, obesity remained a significant risk factor, not only of rising PSA levels, but also with cancer recurrence and metastasis. The researchers are not sure why this may be the case.

Abstract
Influence of obesity on biochemical and clinical failure after external-beam radiotherapy for localized prostate cancer

The research was funded by the National Cancer Institute (NCI); Grant Number: CA84964, CA90270, NIEHS ES07784

The research team:

Sara S. Strom, PhD
Department of Epidemiology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
Ashish M. Kamat, MD
Department of Urology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
Stephen K. Gruschkus, MPH
Department of Epidemiology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
Yun Gu, PhD
Department of Epidemiology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
Sijin Wen, MS
Department of Biomathematics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
Min Rex Cheung, MD, PhD
Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
Louis L. Pisters, MD
Department of Urology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
Andrew K. Lee, MD
Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
Charles J. Rosser, MD
Department of Urology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
Deborah A. Kuban, MD
Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas

Written by: Christian Nordqvist
Editor: Medical News Today

Obesity In Prostate Cancer Patients Predicts Cancer Recurrence And Progression

Obesity in a patient is an independent predictor of whether localized prostate cancer will progress following radiotherapy treatment, say researchers at M. D. Anderson Cancer Center.

In a study reported in the Aug. 1 issue of the journal Cancer, researchers found that moderately and severely obese patients had a 99 percent greater risk of developing biochemical failure (an early marker of cancer progression) than other patients. The study also reports that obese patients had a 66 percent increased risk of having a tumor that recurs or becomes metastatic than did non-obese patients.

This finding mirrors results from a parallel study by M. D. Anderson researchers, reported last year in Clinical Cancer Research, that found that a history of weight gain or obesity at the time of diagnosis also played a role in how aggressive prostate cancer may become after surgery.

"Together, these studies confirm that a man's body mass index (BMI = weight/height2) can be a significant factor in how well he fares after standard treatments for prostate cancer," says the lead researcher of both studies, Sara Strom, Ph.D., an associate professor in the Department of Epidemiology.

"The fact that the same association was found among patients with different risk profiles, and who were treated with different therapies, would suggest that poorer outcomes in obese men are not related to differences in treatment as much as to differences in tumor behavior between obese and non-obese men," she says.

Strom adds that these findings suggest that obese prostate cancer patients should be followed more closely after treatment. "When patients and their physicians are uncertain about the need for further therapy, our research indicates that a man's weight should be factored into that decision," she says.

According to Strom, the study is the first to examine the relationship between obesity and prostate cancer progression after primary therapy with external beam radiotherapy, a common treatment option. The researchers sought to determine whether obesity is an independent predictor of biochemical failure - a rising prostate specific antigen (PSA) level that can indicate advancing cancer - and they also wanted to know if the cancer actually progressed among those patients.

To conduct the study, the scientists examined the records of 873 patients whose prostate cancer was locally confined, and who were treated with radiotherapy at M. D. Anderson between 1988 and 2001. Of these patients, 18 percent were mildly obese and 5 percent were moderately to severely obese.

They found that patients who were obese tended to be diagnosed with prostate cancer at an earlier age than patients who were not obese, and also that African-American men had the highest obesity rates.

After an average follow-up period of 96 months, 295 patients experienced biochemical failure, and cancer recurred in 127 of these patients.

After adjusting for clinical and treatment variables among patients, the researchers found that BMI significantly predicted whether a patient would experience both rising PSA and a return of prostate cancer. For example, biochemical failure occured more quickly with increased BMI: an average of 30 months for patients with normal weight, and 26 months for patients deemed moderately to severely obese. Researchers also found that when comparing obese patients with non-obese patients, obese men had a significantly higher rate of cancer recurrence.

Strom and her colleagues cannot yet say why excess BMI contributed to cancer progression, or whether losing weight after a prostate cancer diagnosis will make any difference in outcome. "But by knowing this association, we may be able to design rational preventive strategies," she says.

###

Co-authors of the study, which was funded by the National Cancer Institute, are all from M. D. Anderson. They are Ashish Kamat, M.D.; Stephen Gruschkus; Yun Gu, Ph.D.; Sijin Wen; Rex Min Cheung, M.D., Ph.D.; Louis Pisters, M.D.; Andrew Lee, M.D.; Charles Rosser, M.D.; and Deborah Kuban, M.D.

Contact: Stephanie Dedeaux
University of Texas M. D. Anderson Cancer Center

For Men With Prostate Cancer, Treatment Information Fails To Address Fears

Men with prostate cancer make emotionally driven treatment decisions influenced by anecdote and misconception rather than consideration of clinical trial evidence, according to a new study. Published in the August 1, 2006 issue of CANCER (http://www.interscience.wiley.com/cancer-newsroom), a peer-reviewed journal of the American Cancer Society, the study reveals that fear and uncertainty drove initial treatment decisions seeking rapid results, and that there was little interest in seeking second opinions. Furthermore, patient decisions were influenced by misconceptions about disease management options, and men often erroneously applied the anecdotal experiences of others with prostate cancer to their own circumstances, even when the severity of their own disease and available treatment options were significantly different.

While there are several treatment options for men with localized prostate cancer, clinical trials have failed to demonstrate one optimal therapy. Each treatment option has benefits and its own unique and significant adverse side effects. Radical prostatectomy, for example, has only minimal survival benefits compared to even observation, but is associated with complications, such as impotence and urinary incontinence. With no clear-cut medical guidance, patients must assume a greater role in deciding on treatment in the face of disquieting statistics and risk-benefit information.

To characterize the factors that influence men's treatment decisions, Thomas Denberg, M.D., Ph.D. of the University of Colorado at Denver and Health Sciences Center and colleagues interviewed 20 men newly diagnosed with localized prostate cancer before and after treatment.

Three factors characterized the patients' decisions: fear and uncertainty; misconceptions about treatment efficacy and risks; and anecdotal information about other's experiences with prostate cancer. Even though most patients knew prostate cancer grows slowly, such "abstract knowledge did little to dispel the vividly frightening, yet unlikely prospect of prostate cancer suddenly 'blossoming,'" the researchers write.

After urologists reviewed the risks and benefits of the treatment options, patients had poor recall of the information they were provided, often confused side effects and treatments, and often said that the side effects had no impact on their treatment decision. Sixteen of 20 men did not intend to seek a second opinion, generally because of misconceptions about its purpose.

Dr. Denberg and his colleagues report that "this study illustrates that while attention to health information, outcome preferences, and the framing of numerical risk is necessary, it is hardly sufficient for achieving quality in patient-centered decision-making." It is important to give greater attention to patients' fears, misconceptions, and anecdotal influences.

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Article: "Patient Treatment Preferences in Localized Prostate Carcinoma: The Influence of Emotion, Misconception, and Anecdote," Thomas D. Denberg, Trisha V. Melhado, John F. Steiner, CANCER; Published Online: June 26, 2006 (DOI: 10.1002/cncr.22033); Print Issue Date: August 1, 2006.

Contact: David Greenberg
John Wiley & Sons, Inc.

Breast Cancer Drug To Extend Lives Of Men With Late Stage Prostate Cancer

Today, the National Institute of Health and Clinical Excellence (NICE), UK, releases guidance that recommends that all eligible patients have access to a prostate cancer drug[1] - a move that will affect the lives of thousands of men across the UK[2].

Taxotere® (docetaxel) - which has been routinely given to female patients with late stage breast cancer since 2001[3] - extends the lives of men with late stage prostate cancer (metastatic hormone refractory prostate cancer - mHRPC) and improves their quality of life[4].

Prostate cancer is the most common cancer of men in the UK; over 30,000 men are diagnosed with the condition each year[5]. In addition, it is the second most common form of cancer death, annually killing over 10,000 men - that's approximately one death every hour[2]. Although data is limited, it is believed that the majority of these deaths are due to late stage prostate cancer[6]. Late stage prostate cancer is a form of prostate cancer in which patients have become resistant to conventional treatments (hormone therapy).

Patients and patient groups welcome today's guidance and are calling for all men who could benefit to be given immediate access to the treatment, which could extend their lives and improve their quality of life for their remaining months. "NICE guidance supporting the use of Taxotere (docetaxel) based regimens for women with late stage breast cancer has been available since 2001," says John Anderson, CEO, Prostate Research Campaign UK. "It's about time that men are also able to get to the front of the queue to gain equal access to a treatment that could benefit them. Now that the guidance has arrived there is no excuse for men who could benefit not to get access as quickly as possible. "

"Taxotere (docetaxel) is the first treatment to improve survival, improve quality of life and reverse progress of metastatic hormone refractory prostate cancer," Professor Nick James, Consultant Clinical Oncologist, University Hospital Birmingham NHS Trust (Queen Elizabeth Cancer Centre), Birmingham and UK principal investigator on TAX 327. "Now that NICE have supported the use of this treatment, we urge all PCTs to ensure that funding is available for all patients whom could benefit. It is now up to patients to make sure that they are asking for this treatment, clinicians to offer it and PCTs to fund it."

"The provision of Taxotere (docetaxel) is one of the most important advances in treating late stage prostate cancer that has occurred in recent years," says John Anderson, Consultant Urological Surgeon, Sheffield. "Now that we have been able to demonstrate that Taxotere is able to extend survival and manage quality of life in late stage prostate cancer, exciting trials have been initiated which will examine the benefits of Taxotere in early stage prostate cancer."

NICE's guidance was based on the highly influential TAX 327 trial, published in a well-respected journal, the New England Journal of Medicine, in October 2004. The trial found that Taxotere® (docetaxel), plus prednisolone (prednisone), improved overall patient survival by 24%. Median patient survival with the Taxotere based regimen was 18.9 months compared to 16.5 months for the standard treatment (mitoxantrone).

Taxotere® (docetaxel) is recommended, within its licensed indications, as a treatment option for men with hormone-refractory metastatic prostate cancer only if their Karnofsky performance-status score is 60% or more. The Karnofsky score is a measure of quality of life factors.

Taxotere® (docetaxel) has an acceptable increase of side effects. The most commonly reported adverse reaction associated with Taxotere® (docetaxel) is neutropaenia (low white cell count, which may lead to infection), which is reversible and not cumulative[7].

Other common side effects include flushing, skin rash, chest tightness, back pain, anaemia, nausea, sore mouth and taste change, diarrhoea, hair loss, hypersensitivity and tiredness.

http://www.sanofi-aventis.com

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[1] National Institute for Health and Clinical Excellence (NICE). Guidance: Docetaxel for treatment of hormone-refractory metastatic prostate cancer. June 2006. Available from: http://www.nice.org.uk

[2] Cancer Research UK. Prostate Cancer Mortality Statistics.
Accessed: June 2006.

[3] National Institute for Health and Clinical Excellence (NICE). Guidance: Taxanes for the treatment of breast cancer. Review 30. Available from: http://www.nice.org.uk

[4] Tannock IF et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004, 351:1502

[5] Cancer Research UK. Prostate Cancer Incidence Statistics.
Accessed: June 2006.

[6] National Institute of Health and Clinical Excellence (NICE). Docetaxel for the treatment of hormone-refractory metastatic prostate cancer (overview). 2005. Available from: http://www.nice.org.uk

[7] Taxotere Summary of Product Characteristics (May 2006)

Obesity Is Associated With Less Favorable Outcome After Radiation Therapy For Prostate Cancer

Obese men with prostate cancer are at higher risk for treatment failure after primary radiation therapy, according to a new study. Published in the August 1, 2006 issue of CANCER (http://www.interscience.wiley.com/cancer-newsroom), a peer-reviewed journal of the American Cancer Society, the study reveals that each incremental increase in body mass index (BMI) increased the risk for clinical or biochemical failure. The study is the first to investigate the association between obesity and post-radiotherapy outcome.

Evidence has increasingly shown that obesity has a deleterious effect on the human body, from the risk of diabetes to joint disease. Obesity has more recently been shown to play a significant role in the development of some cancers, including cancers of the breast, prostate, colon, and many others. Obesity has also been associated with the progression of disease. Obese men with prostate cancer often have more aggressive disease and higher mortality rates. Researchers postulate that fat tissue influences concentrations of various significant signaling molecules, such as testosterone, estrogen, insulin and insulin-like growth factor, which play a role in prostate cancer development and progression.

There is already a body of scientific evidence demonstrating that obesity is linked to treatment failure after prostatectomy. However, there are no data on the effects of obesity on the effectiveness of radiation treatment for prostate cancer. Sara Strom, Ph.D. of the University of Texas M. D. Anderson Cancer Center in Houston and colleagues reviewed the medical records of 873 patients who received radiotherapy alone for prostate cancer. Among the group, 18 percent were mildly obese and 5 percent were moderately to severely obese.

After an average 96 months of follow-up, 295 of the men had three consecutive increases in blood PSA, indicating biochemical failure. Meanwhile, 127 of the men had clinical failure (local recurrence and/or distant metastasis) determined by radiologic studies, biopsy, or physical examination. On analysis, risk of biochemical and clinical failure were influenced by BMI. As BMI increased, the risk of disease progression following therapy also increased. For example, men who were moderately or severely obese were at double the risk for biochemical failure than other men who were not.

The authors conclude, "our findings validate the importance of obesity in prostate cancer progression and suggest a link to the biology of this tumor."

To understand the influence of obesity on treatment and possibly exploit that understanding to improve treatment outcome, "future studies should evaluate the relationship of obesity with dietary factors, genetic modifiers of steroid androgen metabolism, insulin, and a detailed investigation of the insulin growth factor pathway to explore the underlying mechanisms of action in prostate carcinogenesis," suggest the authors.

###

Article: "Influence of Obesity on Biochemical and Clinical Failure After External-Beam Radiotherapy for Localized Prostate Cancer," Sara S. Strom, Ashish M. Kamat, Stephen K. Gruschkus, Yun Gu, Sijin Wen, Min Rex Cheung, Louis L. Pisters, Andrew K Lee, Charles J Rosser, Deborah A. Kuban, CANCER; Published Online: June 26, 2006 (DOI: 10.1002/cncr.22025); Print Issue Date: August 1, 2006.

Contact: David Greenberg
John Wiley & Sons, Inc

Dendreon Announces Publication Of Pivotal Phase 3 Study Highlighting Survival Benefit And Safety Profile Of PROVENGE For Advanced Prostate Cancer

Dendreon Corporation (Nasdaq: DNDN) today announced the publication of the results of its pivotal Phase 3 study (D9901) of PROVENGE(R) (sipuleucel-T) in the July issue of the Journal of Clinical Oncology. The article highlights the significant survival benefit and favorable safety profile of PROVENGE, the Company's investigational active cellular immunotherapy, in men with advanced androgen-independent prostate cancer. The Company plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) later this year to obtain approval to market PROVENGE.

"This trial is an important milestone in the development of new treatments for prostate cancer patients. The survival benefit that was observed has the potential to offer important benefits to patients, and represents the first time an immunotherapy has provided a survival advantage in prostate cancer," said Eric J. Small, M.D., professor of medicine and urology at the University of California, San Francisco and lead author of the publication. "In addition to the observed survival benefit, PROVENGE has a very favorable toxicity and safety profile, with the most common side effects being low grade fevers and chills. A favorable benefit-to-risk profile will be appealing to patients with advanced stage prostate cancer who currently have few appealing treatment options available to them."

The double-blind, placebo-controlled Phase 3 Study D9901 showed that the group of men with asymptomatic, metastatic, androgen-independent prostate cancer who received PROVENGE had a median survival time 4.5 months longer than the median survival seen in the group that had been assigned to receive placebo. For the men who received PROVENGE, there was a 41 percent overall reduction in the risk of death (p-value = 0.010; HR = 1.7). In addition, 34 percent of patients receiving PROVENGE were alive 36 months after treatment compared to 11 percent of patients randomized to receive placebo. These data will form the basis of the Company's BLA to the FDA for marketing approval, which the Company plans to submit later this year.

Patients in the PROVENGE arm had a 31 percent delay in their time to disease progression compared to patients in the placebo arm (p-value = 0.052; HR = 1.45). Furthermore, patients receiving PROVENGE had an approximately 8-fold increase in their T-cell immunity after treatment compared to the placebo group (p < 0.001).

"The survival benefit demonstrated in this trial, combined with the favorable safety profile of PROVENGE, will form the basis for our BLA submission to the FDA later this year," said Mark Frohlich, M.D., vice president of clinical affairs at Dendreon. "We look forward to making this active cellular immunotherapy available for the treatment of the many men with advanced prostate cancer."

The D9901 study was conducted at 19 institutions in the United States and enrolled 127 men with asymptomatic, metastatic androgen-independent (hormone-refractory) prostate cancer. Patients were randomized in a 2:1 ratio to receive three infusions of PROVENGE (n=82) or placebo (n=45) every two weeks for a total of three infusions over a one month period.

Treatment with PROVENGE was generally well tolerated. The majority of side effects were mild, including infusion-related fever and chills that were usually of low grade and typically lasted for one to two days following infusion.

About PROVENGE (sipuleucel-T)

PROVENGE (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system. ACIs hold promise because they may provide patients with a meaningful survival benefit with low toxicities. PROVENGE targets the prostate cancer antigen, prostatic acid phosphatase (PAP), which is found in approximately 95 percent of prostate cancers. PROVENGE is in late-stage development for the treatment of patients with advanced prostate cancer. In clinical studies, patients typically received three infusions over a one-month period as a complete course of therapy.

About Prostate Cancer

Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 232,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year of the disease.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. The Company uses its experience in antigen identification, antigen engineering and antigen-presenting cell processing to produce active immunotherapy product candidates to potentially stimulate a cell-mediated immune response. PROVENGE (sipuleucel-T) is Dendreon's lead active cellular immunotherapy in Phase 3 development for prostate cancer. The Company also discovered Trp-p8, a cold receptor and transmembrane ion channel in pre-clinical development, which is over-expressed in breast, prostate, lung and colon cancers. For more information about the Company and its programs, visit http://www.dendreon.com.

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of a clinical trial for PROVENGE will not support an application for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at http://www.sec.gov.

Dendreon Corporation
http://www.dendreon.com/

Study Examines The Use Of A Novel Suprapubic Catheter In Suprapubic Prostatectomy

UroToday.com - It is well known that in addition to urethral catheter associated discomfort, there is an increased risk of ascending urethral infection, inflammation and stricture formation with urethral catheters. Despite the emergence of a multitude of minimally invasive treatments for BPH, the traditional TURP or suprapubic prostatectomy is still commonly performed. Open prostatectomy offers the advantage of a lower re-treatment rate and more complete removal of the prostate adenoma under direct vision, while it avoids the risk of TUR syndrome.

The post-operative morbidity of the suprapubic prostatectomy includes hemorrhage, clot retention, incontinence, urethral or bladder neck stricture and UTI. Some are related to the use of urethral catheters, such a severe bladder irritation, ascending UTI or epididymoorchitis and urethral stricture formation.

A recent report examines the use of a novel catheter, instead of the traditional urethral catheter, for the post-operative urinary drainage after a suprapubic prostatectomy. The study, by H. Djaladat and colleagues from Tehran Iran, is published in the June 2006 issue of the Journal of Urology.

A total of 146 patients underwent suprapubic prostatectomy for refractory lower urinary tract symptoms or urinary retention. Of the patients, 96 were treated with a novel technique without a urethral catheter but with a specially configured 24 F 3-way suprapubic tube. The tube was placed suprapubically and the end drainage holes were tied off with a silk suture. The balloon was filled within the prostatic fossa after adenoma enucleation and two additional drainage holes were made in the side of the catheter that lies within the bladder to allow for urinary drainage and irrigation. The tube was fixed at the dome of the bladder using a purse string suture to prevent migration. A closed suction drain was placed in the space of Reitzius. Fluid was removed slowly from the novel catheter balloon as the urine cleared. The balloon was completely emptied between 24 and 36 hours and the catheter was removed in 5 to 7 days. The mean balloon fluid volume was 29.5 cc. Post-operative indices were compared between the group using the novel catheter and a group of 48 patients using traditional urethral and suprapubic catheters.

Analysis of the results showed that there was no report of clot retention or significant irritation in the novel catheter group, while 22 (44%) and 19 (38%) in the control group had significant irritative symptoms and at least 1 episode of clot retention. The post-operative decrease in hemoglobin was 0.8 mg/dl in the novel group and 1.9 mg/dl in the control group. There were no reports of epididymoorchitis with the novel catheter but this was identified in 4 (8%) in the control group (p < 0.05). In follow-up at 6 months, all patients underwent cystoscopy. The incidence of membranous urethral strictures was 4.1% in the novel catheter group and 14% in the control group. Four more patients had penile urethral stricture and 3 had bladder neck contractures in the control group. Early incontinence (1 week post-operatively) was also reported in 4% of patients with the novel catheter but in 62% of the control group. It did improve in 95% of patients.

This study suggests improved immediate post-operative morbidity with the use of the novel urinary catheter for use in suprapubic prostatectomy with a decrease in the incidence of urethral stricture disease.

By Michael J. Metro, MD

Reference:
J Urol. 2006 June; 175(6):2083-6
Link Here.
Djaladat H, Mehrsai A, Saraji A, Moosavi S, Djaladat Y, Pourmand G

UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to:
http://www.urotoday.com

Copyright © 2006 - UroToday

Intermittent Androgen Deprivation In Biochemical Recurrence Of Prostate Cancer After Radiotherapy

UroToday.com - Intermittent androgen deprivation (IAD) is commonly used in the treatment of CaP, which theoretically may delay the development of hormone resistance. Dr. Bruchovsky and associates report the outcomes of a Phase II trial using IAD in patients with biochemical recurrence following radiotherapy in the epub version of Cancer.

A group of 103 patients with a PSA of >6ng/ml but no evidence of metastasis were enrolled in the study. They received cyproterone acetate and leuprolide as treatment, with leuprolide given every 4 weeks for up to 8 doses. The leuprolide was then stopped if the PSA level at weeks 24 and 32 was <4.0ng/ml.and resumed when the PSA level was >10ng/ml. Development of androgen independence was defined as 3 sequential increases in the PSA despite castrate levels of serum testosterone.

Mean patient age at study entry was 73 years and mean PSA was 21.2ng/ml. Mean follow-up was 3.7 years. The total number of treatment cycles was 277. The mean time on treatment in cycles 1 and 2 was 36 weeks, which decreased in cycles 3-5. This was because some patients either progressed or reached the end of the study. The average time off treatment was 64 weeks in cycle 1, decreasing 22-27% in cycles 2 -4. Prostate volume decreased in the first 3 cycles (by 40% in cycle 1), but not thereafter.

The main reasons for ending trial participation were end of study in 39%, progression in 24%, and death in 16%. Gleason score had no significant effect on cycle times.

The shortening cycle times are consistent with IAD selecting for patients who have the most androgen-sensitive tumors. This Phase II trial supports that IAD is feasible in this cohort of patients and has few adverse side effects.

By Christopher P. Evans, MD

Reference:
Cancer. 2006 Jun 16; [Epub ahead of print]
Link Here.
Bruchovsky N, Klotz L, Crook J, Malone S, Ludgate C, Morris WJ, Gleave ME, Goldenberg SL

UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to:
http://www.urotoday.com

Copyright © 2006 - UroToday

Parameters Associated With Patient Outcomes In Lymph Node Positive Prostate Cancer

UroToday.com - Dr. Hofer and colleagues report in the June issue of Urology that lymphovascular invasion (LVI) and the nuclear grade of the primary prostate tumor are independent predictors of PSA recurrence in men with lymph node positive CaP.

The retrospective study included 119 eligible men with lymph node positive CaP who underwent radical prostatectomy at the University of Ulm Hospital, Germany. Clinical and pathologic examination was performed.

The mean number of lymph nodes removed was 12 and the mean number positive was 3. Almost 50% of men had only 1 positive node, 22% had 2 and 34% had more than 2 positive nodes. PSA failure occurred n 41% of these men, leaving 59% free of disease with a mean follow-up of 41 months. The 5-year PSA failure-free survival rate was 61% and the mean PSA failure-free survival time was 54 months.

The metastatic growth pattern in the lymph nodes was similar to the architectural growth pattern used for grading the primary tumor. Extra-nodal extension was seen in 55% of the cases, and 25% had lymph nodes with LVI.

Pre-operative PSAS was not predictive of a PSA failure. However, multivariable analysis demonstrated that LVI of the metastasis and nuclear tumor grade were associated with PSA recurrence. These pathologic parameters may help to identify patients at risk for disease recurrence and direct them towards adjuvant therapies and clinical trials.

By Christopher P. Evans, MD

Reference: Urol 2006;67:1016-1021
Link Here.
Hofer MD, Kuefer R, Huang W, Li H, Bismar TA, Perner S, Hautmann RE, Sanda MG, Gschwend JE, Rubin MA

UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to:
http://www.urotoday.com

Copyright © 2006 - UroToday

Prostatic Irradiation Doesn't Lead To Any Appreciable Increase In Rectal Cancer Risk

Men who receive radiation therapy for prostate cancer are not at any appreciable increased risk of developing rectal cancer compared to those not given radiation therapy, according to a new study published in the July 1, 2006, issue of the International Journal of Radiation Oncology*Biology*Physics, the official journal of ASTRO, the American Society for Therapeutic Radiology and Oncology.

This year, 235,000 American men will be diagnosed with prostate cancer. The main ways of dealing with the disease are radiation therapy, surgery and watchful waiting - each of which has its benefits and disadvantages. Researchers have hypothesized that one disadvantage of using radiation to kill the cancer cells in the prostate is that it might also make men more likely to develop cancer in the nearby rectum.

In this study, doctors in Canada evaluated the records of 237,773 men who had prostate cancer. Of them, 33,841 received radiation therapy, 167,607 had their prostate removed surgically and 36,335 received neither treatment. On an initial simple evaluation, doctors found that rectal cancer developed in 243 men who received radiation (0.7 percent), 578 men treated with surgery (0.3 percent), and 227 of the men given neither treatment (0.8 percent). Once doctors had adjusted for the age differences between all the men in the irradiated and non-irradiated groups, they could not find any significant increased risk of rectal cancer in the irradiated men compared to those not given radiation therapy.

"Rectal cancer from other causes is frequent enough in our population to obscure any small incidence of radiation-induced cancer. I hope that the results of this study will help men with prostate cancer and their families put these risks in their proper perspective, and not let their concerns about rectal cancer dissuade them from choosing radiation therapy as a treatment for this disease," said Wayne S. Kendal, M.D., Ph.D., an Associate Professor in Radiation Oncology at the Ottawa Hospital Regional Cancer Centre in Ontario, Canada.

ASTRO (American Society for Therapeutic Radiology and Oncology) is the largest radiation oncology society in the world, with more than 8,500 members who specialize in treating patients with radiation therapies. As the leading organization in radiation oncology, biology and physics, the Society is dedicated to the advancement of the practice of radiation oncology by promoting excellence in patient care, providing opportunities for educational and professional development, promoting research and disseminating research results and representing radiation oncology in a rapidly evolving socioeconomic healthcare environment.

The American Society for Therapeutic Radiology and Oncology
8280 Willow Oaks Corporate Drive, Suite 500
Fairfax, VA 22031
http://www.astro.org
http://www.rtanswers.org

Please plan to join us at ASTRO's upcoming meetings.
* September 8-10, 2006: Translational Research in Radiation Oncology, Physics and Biology - Boston
* September 15-16, 2006: Health Services/Outcomes Research in Oncology - San Diego
* November 5-9, 2006: 48th Annual Scientific Meeting - Philadelphia
Visit here for more information.

Pomegranate Juice Helps Keep PSA Levels Stable In Men With Prostate Cancer, Jonsson Cancer Center Study Finds

Drinking an eight ounce glass of pomegranate juice daily increased by nearly four times the period during which PSA levels in men treated for prostate cancer remained stable, a three-year UCLA study has found.

The study involved 50 men who had undergone surgery or radiation but quickly experienced increases in prostate-specific antigen or PSA, a biomarker that indicates the presence of cancer. UCLA researchers measured "doubling time," how long it takes for PSA levels to double, a signal that the cancer is progressing, said Dr. Allan Pantuck, an associate professor of urology, a Jonsson Cancer Center researcher and lead author of the study.

Doubling time is crucial in prostate cancer, Pantuck said, because patients who have short doubling times are more likely to die from their cancer. The average doubling time is about 15 months. In the UCLA study, Pantuck and his team observed increases in doubling times from 15 months to 54 months, an almost four-fold increase.

"That's a big increase. I was surprised when I saw such an improvement in PSA numbers," Pantuck said. "In older men 65 to 70 who have been treated for prostate cancer, we can give them pomegranate juice and it may be possible for them to outlive their risk of dying from their cancer. We're hoping we may be able to prevent or delay the need for other therapies usually used in this population such as hormone treatment or chemotherapy, both of which bring with them harmful side effects."

The study appears in the July 1 issue of Clinical Cancer Research, the peer-reviewed journal of the American Association of Cancer Research.

"This is not a cure, but we may be able to change the way prostate cancer grows," Pantuck said. "We don't know yet the specific factors behind this response - that's our next step in this research. We want to find out what cell signaling pathways might be affected, what is happening to keep PSA levels stable."

Pomegranate juice is known to have anti-inflammatory effects and high levels of anti-oxidants, which are believed to protect the body from free-radical damage. It also contains poly-phenols, natural antioxidant compounds found in green tea, as well as isoflavones commonly found in soy, and ellagic acid, which is believed to play a role in cancer cell death.

"There are many substances in pomegranate juice that may be prompting this response," Pantuck said. "We don't know if it's one magic bullet or the combination of everything we know is in this juice. My guess is that it's probably a combination of elements, rather than a single component."

The levels of PSA in men immediately following treatement should be undetectable, Pantuck said. If PSA can be detected, it's an indication of an aggressive cancer that is likely to progress. The men in Pantuck's study all had detectable PSA following treatment. Of the 50 men enrolled, more than 80 percent experienced improvement in doubling times.

Conventional treatment for men with recurrent prostate cancer includes hormonal therapy, a chemical castration which removes testosterone from the system. Men treated with hormonal therapy can experience hot flashes, osteoporosis, fatigue, depression, muscle wasting, loss of libido and erectile dysfunction. If drinking pomegranate juice can delay or prevent the need for hormonal therapy, patients would experience a better quality of life for a longer time, Pantuck said.

The patients in Pantuck's study experienced no side effects and none of the participants had cancers that metastasized during the study.

Pantuck, along with UCLA colleagues including Dr. Arie Belldegrun, professor and chief of urologic oncology, and Dr. David Heber, professor and director of the Center for Human Nutrition, first began research on pomegranate juice in prostate cancer about six years ago, conducting preclinical research in cell cultures and in animals. Those studies showed pomegranate juice slowed the growth of prostate cancer, Pantuck said.

The data was impressive enough to test pomegranate juice in clinical trials, Pantuck said. To confirm their findings, a larger Phase III study, headed up by UCLA, will be conducted at ten centers across the county. UCLA is the only Southern California center involved in the study. For more information on the Phase III trial, call (310) 825-5538.

Pantuck said he has men on the study more than three years out who are not being treated for prostate cancer other than drinking pomegranate juice and their PSA levels continue to be suppressed.

"The juice seems to be working," he said.

The study, performed at the Clark Urology Center, was funded by the Stuart and Linda Resnick Trust. The Resnicks own POM Wonderful, which provided the juice for the study.

UCLA's Jonsson Comprehensive Cancer Center comprises more than 240 researchers and clinicians engaged in research, prevention, detection, control, treatment and education. One of the nation's largest comprehensive cancer centers, the Jonsson center is dedicated to promoting research and translating the results into leading-edge clinical studies. In July 2005, the Jonsson Cancer Center was named the best cancer center in the western United States by U.S. News & World Report, a ranking it has held for six consecutive years.

For more information on the Jonsson Cancer Center, visit our web site at http://www.cancer.mednet.ucla.edu.

UCLA's Jonsson Cancer Center
UCLA Institute for Stem Cell Biology and Medicine

Study Shows Prostate Cancer Vaccine Linked To Longer Survival

A University of California, San Francisco study has found that men with advanced, often untreatable prostate cancer who received a therapeutic cancer vaccine went on to survive longer than those receiving a placebo.

Study findings showed the vaccine group lived up to an average of four-and-a-half months longer and had a greater than three-fold increase in survival at 36 months when compared to patients in the placebo group.

The study is reported in the July 1, 2006 issue of the Journal of Clinical Oncology.

The double-blind, placebo-controlled phase III clinical trial was conducted to test the efficacy of the vaccine, called sipuleucel-T, in delaying disease progression and prolonging survival in patients with asymptomatic metastatic hormone refractory prostate cancer (HRPC).

Study results showed that the vaccine was well-tolerated by participants. The most common reported adverse effects such as fever and chills were typically mild.

Led by Eric J. Small, MD, UCSF professor of medicine and urology, the study was conducted in collaboration with 19 institutions in the United States and funded by the Dendreon Corporation, a biotechnology company that developed the vaccine.

"This trial is an important milestone in the development of new treatments for prostate cancer patients," said Small. "The potential survival benefit that was observed may offer important benefits to patients and would represent the first time that immunotherapy has provided a survival advantage in prostate cancer."

Sipuleucel-T, known by its product name Provenge, is an investigational immunotherapy vaccine designed to stimulate T-cell immunity to prostatic acid phosphatase, an antigen found in about 95 percent of prostate cancers but not in non-prostate tissue.

A total of 127 patients with asymptomatic metastatic HRPC received three transfusions of sipuleucel-T or placebo every two weeks. Of this group, 115 patients had progressive disease at the time of data analysis and all patients were followed for survival for 36 months.

Prostate cancer is the most common non-skin cancer in the U.S. with more than 200,000 new cases each year. It is the third leading cause of cancer deaths in men after lung and colorectal cancer. Unlike prostate cancer that is detected early, asymptomatic metastatic HRPC is resistant to traditional hormonal therapy, and treatment options have been limited.

The study showed that the median overall survival was 25.9 months for sipuleucel-T-treated patients and 21.4 months for placebo-treated patients. After three years, survival was 34 percent for those treated with the vaccine compared to 11 percent for those taking the placebo.

The clinical trial did not meet its primary endpoint of demonstrating a statistically significant difference in progression of the disease from diagnosis, according to Small.

"We found that the time to disease progression for sipuleucel-T was 11.7 weeks compared to 10.0 weeks for placebo," he said. "This shows the difficulties in using the worsening of the disease as an intermediate marker for overall survival of patients treated with immunotherapy. The study however, suggests that sipueucel-T may provide a survival advantage to asymptomatic HRPC patients."

Many of the phase I and II clinical trials of the vaccine were also undertaken at UCSF and led by Small. He first presented results from the phase III trial at the 2005 meeting of the American Society of Clinical Oncology.

Dendreon Corporation, based in Seattle, Washington, hopes to market the Provenge product commercially in the coming year.

###

Co-authors of the study are Paul F. Schelhammer, Eastern Virginia Medical School, Norfolk, VA; Celestia S. Higano, University of Washington; Charles H. Redfern, Sharp Healthcare, San Diego; John J. Nemunaitis, Mary Crowley Medical Research Center, Dallas; and Frank H. Valone, Suleman S. Verjee, Lori A. Jones and Robert M. Hershberg, Dendreon Corporation.

UCSF is a leading university that consistently defines health care worldwide by conducting advanced biomedical research, educating graduate students in the life sciences, and providing complex patient care.

Contact: Nancy Chan
University of California - San Francisco

Cell Genesys Announces Publication Of Encouraging Phase 1/2 Clinical Results For GVAX(R) Immunotherapy For Prostate Cancer In Early Stage Patients

Cell Genesys, Inc. (Nasdaq: CEGE) today announced that the results from an initial clinical trial of GVAX(R) immunotherapy for prostate cancer in patients with early-stage disease have been published in a June issue of Clinical Cancer Research by a team led by Jonathan Simons, M.D., professor of Hematology and Oncology, Winship Cancer Institute, Emory University School of Medicine. The Phase 1/2 trial enrolled 21 patients with rising prostate specific antigen (PSA) levels following prostatectomy and who had not received any other treatment for their prostate cancer, including hormone therapy. The results showed that 16 of 21 (76%) patients showed a statistically significant decrease in the rate of rise of PSA (PSA slope) post-treatment compared with the remaining five patients (p<0.001). One patient had a partial PSA response (>50% reduction of PSA) of 7-month duration. GVAX cancer immunotherapy was generally well tolerated, with self-limited injection site reactions, and mild flu-like symptoms being the most frequently reported side effects. In addition to clinical activity, the publication reported immunologic findings confirming that GVAX immunotherapy for prostate cancer resulted in the induction of immune responses as evidenced by the formation of antibodies directed against prostate cancer cells.

Cell Genesys has completed five Phase 1 and Phase 2 clinical trials of GVAX immunotherapy for prostate cancer in approximately 200 patients with various stages of recurrent prostate cancer, and each trial has demonstrated a favorable safety profile. The initial Phase 1 /2 clinical trial in early- stage prostate cancer described in the above publication was conducted at Johns Hopkins Oncology Center. GVAX immunotherapy treatment was administered at a fixed dose in eight weekly intradermal injections in an outpatient setting. As noted above, one patient had a partial PSA response of 7-month duration which was associated with a corresponding decline in the tumor- associated marker, carcinoembryonic antigen (CEA), as well as induction of a high titer antibody response against a prostate cancer antigen. The titer of this antibody decreased when treatment ended, and subsequent tumor progression based on a rising PSA occurred. In addition, several candidate tumor- associated antigens recognized by treatment-induced antibodies were identified in the study, including antigens reported to be involved in modulation of immune response and cancer metastases.

"While our Phase 3 clinical trials and registration strategy for GVAX immunotherapy for prostate cancer are currently focused on the treatment of advanced prostate cancer, we are pleased to also obtain these encouraging results in an earlier-stage of the disease," said Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "We believe that GVAX immunotherapy for prostate cancer may have potential for the treatment of prostate cancer at various stages of the disease and we look forward to initiation of future label-expansion studies."

GVAX immunotherapy for prostate cancer is currently being studied in two Phase 3 clinical trials expected to enroll approximately 1200 patients with metastatic hormone-refractory prostate cancer (HRPC), comprising one of the largest Phase 3 clinical programs ever conducted in men with advanced prostate cancer. The first trial (VITAL-1) is enrolling chemotherapy naпve, asymptomatic patients without cancer-related pain and will compare GVAX cancer immunotherapy to Taxotere chemotherapy plus prednisone. The second trial (VITAL-2) is enrolling patients who are symptomatic with cancer-related pain and will compare GVAX cancer immunotherapy plus Taxotere to Taxotere plus prednisone. Each Phase 3 trial is expected to enroll 600 patients and is designed to demonstrate a survival benefit compared to Taxotere plus prednisone. Cell Genesys received Special Protocol Assessments (SPA) from the FDA for each of the VITAL-1 and VITAL-2 Phase 3 studies as well as Fast Track Status for the product itself.

The company's ongoing Phase 3 program is supported by the median survival results from two, independent, multi-center Phase 2 clinical trials in approximately 115 patients that are not only consistent with each other, but also compare favorably to the previously published median survival of 18.9 months for metastatic HRPC patients treated with Taxotere(R) (docetaxel) chemotherapy plus prednisone, the current standard of care. The Phase 3 program is designed to confirm this potential survival benefit for GVAX immunotherapy for prostate cancer.

Cell Genesys' GVAX cancer immunotherapies are whole-cell products which are designed to present the immune system with a broad spectrum of tumor antigens and stimulate an immune response against the patient's tumor. GVAX immunotherapy for prostate cancer is comprised of two prostate cancer cell lines that have been modified to secrete GM-CSF (granulocyte-macrophage colony stimulating factor), an immune stimulatory hormone which plays a key role in stimulating the body's immune response, and then irradiated for safety. GVAX cancer immunotherapy for prostate cancer is being developed as a non patient- specific, "off-the-shelf" pharmaceutical product.

Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms -- GVAX(R) cancer immunotherapies and oncolytic virus therapies. Ongoing clinical trials include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2 trials of GVAX immunotherapy for pancreatic cancer and leukemia, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer. Cell Genesys continues to hold an equity interest in its former subsidiary, Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, CA and has its principal manufacturing operation in Hayward, CA. For additional information, please visit the company's website at http://www.cellgenesys.com.

Statements made herein about the company, other than statements of historical fact, including statements about the company's progress, results and timing of clinical trials and preclinical programs and the nature of product pipelines are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of clinical trials and research and development programs, the regulatory approval process for clinical trials, competitive technologies and products, patents, continuation of corporate partnerships and the need for additional financings. For information about these and other risks which may affect Cell Genesys, please see the company's Annual Report on Form 10-K for the year ended December 31, 2005 filed on March 13, 2006 as well as Cell Genesys' reports on Form 10-Q and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The company assumes no obligation to update the forward-looking information in this press release.

Cell Genesys, Inc.
http://www.cellgenesys.com

Prostatic Irradiation Doesn't Lead To Any Appreciable Increase In Rectal Cancer Risk

Men who receive radiation therapy for prostate cancer are not at any appreciable increased risk of developing rectal cancer compared to those not given radiation therapy, according to a new study published in the July 1, 2006, issue of the International Journal of Radiation Oncology*Biology*Physics, the official journal of ASTRO, the American Society for Therapeutic Radiology and Oncology.

This year, 235,000 American men will be diagnosed with prostate cancer. The main ways of dealing with the disease are radiation therapy, surgery and watchful waiting пїЅ each of which has its benefits and disadvantages. Researchers have hypothesized that one disadvantage of using radiation to kill the cancer cells in the prostate is that it might also make men more likely to develop cancer in the nearby rectum.

In this study, doctors in Canada evaluated the records of 237,773 men who had prostate cancer. Of them, 33,841 received radiation therapy, 167,607 had their prostate removed surgically and 36,335 received neither treatment. On an initial simple evaluation, doctors found that rectal cancer developed in 243 men who received radiation (0.7 percent), 578 men treated with surgery (0.3 percent), and 227 of the men given neither treatment (0.8 percent). Once doctors had adjusted for the age differences between all the men in the irradiated and non-irradiated groups, they could not find any significant increased risk of rectal cancer in the irradiated men compared to those not given radiation therapy.

"Rectal cancer from other causes is frequent enough in our population to obscure any small incidence of radiation-induced cancer. I hope that the results of this study will help men with prostate cancer and their families put these risks in their proper perspective, and not let their concerns about rectal cancer dissuade them from choosing radiation therapy as a treatment for this disease," said Wayne S. Kendal, M.D., Ph.D., an Associate Professor in Radiation Oncology at the Ottawa Hospital Regional Cancer Centre in Ontario, Canada.

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For more information on radiation therapy for prostate cancer, please visit http://www.rtanswers.org/.

ASTRO is the largest radiation oncology society in the world, with more than 8,500 members who specialize in treating patients with radiation therapies. As the leading organization in radiation oncology, biology and physics, the Society is dedicated to the advancement of the practice of radiation oncology by promoting excellence in patient care, providing opportunities for educational and professional development, promoting research and disseminating research results and representing radiation oncology in a rapidly evolving socioeconomic healthcare environment.

Contact: Beth Bukata
American Society for Therapeutic Radiology and Oncology

Pomegranate Juice Helps Keep PSA Levels Stable In Men With Prostate Cancer

Drinking an eight ounce glass of pomegranate juice daily increased by nearly four times the period during which PSA levels in men treated for prostate cancer remained stable, a three-year UCLA study has found.

The study involved 50 men who had undergone surgery or radiation but quickly experienced increases in prostate-specific antigen or PSA, a biomarker that indicates the presence of cancer. UCLA researchers measured "doubling time," how long it takes for PSA levels to double, a signal that the cancer is progressing, said Dr. Allan Pantuck, an associate professor of urology, a Jonsson Cancer Center researcher and lead author of the study.

Doubling time is crucial in prostate cancer, Pantuck said, because patients who have short doubling times are more likely to die from their cancer. The average doubling time is about 15 months. In the UCLA study, Pantuck and his team observed increases in doubling times from 15 months to 54 months, an almost four-fold increase.

"That's a big increase. I was surprised when I saw such an improvement in PSA numbers," Pantuck said. "In older men 65 to 70 who have been treated for prostate cancer, we can give them pomegranate juice and it may be possible for them to outlive their risk of dying from their cancer. We're hoping we may be able to prevent or delay the need for other therapies usually used in this population such as hormone treatment or chemotherapy, both of which bring with them harmful side effects."

The study appears in the July 1 issue of Clinical Cancer Research, the peer-reviewed journal of the American Association of Cancer Research.

"This is not a cure, but we may be able to change the way prostate cancer grows," Pantuck said. "We don't know yet the specific factors behind this response - that's our next step in this research. We want to find out what cell signaling pathways might be affected, what is happening to keep PSA levels stable."

Pomegranate juice is known to have anti-inflammatory effects and high levels of anti-oxidants, which are believed to protect the body from free-radical damage. It also contains poly-phenols, natural antioxidant compounds found in green tea, as well as isoflavones commonly found in soy, and ellagic acid, which is believed to play a role in cancer cell death.

"There are many substances in pomegranate juice that may be prompting this response," Pantuck said. "We don't know if it's one magic bullet or the combination of everything we know is in this juice. My guess is that it's probably a combination of elements, rather than a single component."

The levels of PSA in men immediately following treatement should be undetectable, Pantuck said. If PSA can be detected, it's an indication of an aggressive cancer that is likely to progress. The men in Pantuck's study all had detectable PSA following treatment. Of the 50 men enrolled, more than 80 percent experienced improvement in doubling times.

Conventional treatment for men with recurrent prostate cancer includes hormonal therapy, a chemical castration which removes testosterone from the system. Men treated with hormonal therapy can experience hot flashes, osteoporosis, fatigue, depression, muscle wasting, loss of libido and erectile dysfunction. If drinking pomegranate juice can delay or prevent the need for hormonal therapy, patients would experience a better quality of life for a longer time, Pantuck said.

The patients in Pantuck's study experienced no side effects and none of the participants had cancers that metastasized during the study.

Pantuck, along with UCLA colleagues including Dr. Arie Belldegrun, professor and chief of urologic oncology, and Dr. David Heber, professor and director of the Center for Human Nutrition, first began research on pomegranate juice in prostate cancer about six years ago, conducting preclinical research in cell cultures and in animals. Those studies showed pomegranate juice slowed the growth of prostate cancer, Pantuck said.

The data was impressive enough to test pomegranate juice in clinical trials, Pantuck said. To confirm their findings, a larger Phase III study, headed up by UCLA, will be conducted at ten centers across the county. UCLA is the only Southern California center involved in the study.

Pantuck said he has men on the study more than three years out who are not being treated for prostate cancer other than drinking pomegranate juice and their PSA levels continue to be suppressed.

"The juice seems to be working," he said.

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The study, performed at the Clark Urology Center, was funded by the Stewart and Lynda Resnick Trust. The Resnicks own POM Wonderful, which provided the juice from the Wonderful variety of pomegranate for the study.

UCLA's Jonsson Comprehensive Cancer Center comprises more than 240 researchers and clinicians engaged in research, prevention, detection, control, treatment and education. One of the nation's largest comprehensive cancer centers, the Jonsson center is dedicated to promoting research and translating the results into leading-edge clinical studies. In July 2005, the Jonsson Cancer Center was named the best cancer center in the western United States by U.S. News & World Report, a ranking it has held for six consecutive years.

Contact: Kim Irwin
University of California - Los Angeles

PSA Acceleration Rate Slowed By Pomegranate After Prostate Cancer Surgery, Radiation

Pomegranate juice packs a punch on prostate cancer that prolongs post-surgery PSA doubling time, drives down cancer cell proliferation and causes prostate cancer cells to die, according to a study published in the July 1 issue of Clinical Cancer Research.

Researchers at the Jonsson Cancer Center at UCLA reported that patients with recurrent prostate cancer who drank pomegranate after surgery or radiation treatment saw their PSA blood content levels double after about 54 months. By comparison, PSA levels in the same patients prior to drinking the daily doses of eight-ounce pomegranate juice accelerated more quickly, doubling their PSA levels in only 15 months.

PSA, or prostate specific antigen, is a protein marker for prostate cancer. The faster PSA levels increase in the blood of men after treatment, the greater their potential for dying of prostate cancer.

"The velocity of the increase in PSA is decreased by 35 percent among those who drank the pomegranate juice," said Allan Pantuck, M.D., associate professor, Department of Urology, David Geffen School of Medicine, UCLA, and lead author of the paper.

"We are hoping that pomegranate juice offers a novel strategy for prolonging the doubling time in men who have been treated for prostate cancer," Dr. Pantuck added.

According to the study, sera from patients after treatment yielded a net decrease of almost 30 percent in the numbers of prostate cancer cells raised in culture. Similarly, cultured sera from these patients decreased cell proliferation by 12 percent, compared to cells grown with sera from the men taken prior to initiation of the pomegranate treatment program. In addition, treated sera induced 17 percent more programmed cell death, or apoptosis, than sera from the men prior to treatment.

Additional exploratory experiments conducted by Dr. Pantuck and his colleagues examined antioxidant characteristics of the fruit juice.

"Pomegranate is high in antioxidants, and there is good evidence that inflammation plays an important role in prostate cancer," he said.

Dr. Pantuck and his colleagues detected a 23 percent increase in nitric oxide sera content from patients after they began their daily pomegranate regimen. These studies were conducted in the UCLA laboratory of Louis Ignarro, Ph.D., the Nobel laureate who contributed key scientific findings to define the role of nitric oxide in health and disease.

As with vitamin C and other antioxidants, ellagic acid - a primary antioxidant in pomegranate juice - works to quench molecules that oxidate, or add oxygen, to cellular and circulatory proteins and fats, altering their biological function.

"By quenching oxidative species with antioxidants, you are basically preserving circulating nitric oxide, so it can have a greater biologic effect," Dr. Pantuck said. "By decreasing the amount of free radicals, you are probably decreasing the circulating factors that are destroying nitric oxide."

While their findings on nitric oxide, cell proliferation and apoptosis served as exploratory endpoints, Dr. Pantuck stressed that clinical trials with more precise design are necessary to confirm the biological role the fruit plays in prolonging or preventing recurrence of prostate cancer in men.

"We don't believe we are curing anyone from prostate cancer," he said.

"In our initial trial, although a third of patients experienced a decrease in their PSA during the study, nobody's PSA went to zero.

"The PSA doubling time, however, was longer. For many men, this may extend the years after surgery or radiation that they remain recurrence free and their life expectancy is extended. They may be able to prevent the need to undergo additional therapies, such as radiation, hormonal or chemotherapies."

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Dr. Pantuck's colleagues who contributed to this study included Ignarro, John Leppert, Nazy Zomarodian, William Aronson, Jenny Hong, James Bernard, Navindra Seeram, Harley Liker, Hejing Wang, Robert Elashoff, David Heber, and Arie Belldegrun from the departments of Urology, Medicine, Physiologic Science or Biomathematics at the David Geffen School of Medicine, UCLA. Michael Aviram from the Technion Faculty of Medicine, the Rambam Medical Center, Bat - Galim, Haifa, Israel, also contributed to these studies.

Funding to support these studies came from the Lynda and Stewart Resnick Revocable Trust. The Resnicks are the owners of the POM Wonderful Company. Additional NIH funding (P50CA92131 and IR01CA100938) supported portions of the science conducted in the course of these experiments.

The mission of the American Association for Cancer Research is to prevent and cure cancer. Founded in 1907, AACR is the world's oldest and largest professional organization dedicated to advancing cancer research. The membership includes more than 24,000 basic, translational, and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and more than 60 other countries. AACR marshals the full spectrum of expertise from the cancer community to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs. It funds innovative, meritorious research grants. The AACR Annual Meeting attracts more than 17,000 participants who share the latest discoveries and developments in the field. Special Conferences throughout the year present novel data across a wide variety of topics in cancer research, treatment, and patient care. AACR publishes five major peer-reviewed journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; and Cancer Epidemiology, Biomarkers & Prevention. Its most recent publication, CR, is a magazine for cancer survivors, patient advocates, their families, physicians, and scientists. It provides a forum for sharing essential, evidence-based information and perspectives on progress in cancer research, survivorship, and advocacy.

Contact: Warren Froelich
American Association for Cancer Research

Cell Genesys Announces Publication Of Encouraging Phase 1/2 Clinical Results For GVAX(R) Immunotherapy For Prostate Cancer

Cell Genesys, Inc. (Nasdaq: CEGE) today announced that the results from an initial clinical trial of GVAX(R) immunotherapy for prostate cancer in patients with early-stage disease have been published in a June issue of Clinical Cancer Research by a team led by Jonathan Simons, M.D., professor of Hematology and Oncology, Winship Cancer Institute, Emory University School of Medicine. The Phase 1/2 trial enrolled 21 patients with rising prostate specific antigen (PSA) levels following prostatectomy and who had not received any other treatment for their prostate cancer, including hormone therapy. The results showed that 16 of 21 (76%) patients showed a statistically significant decrease in the rate of rise of PSA (PSA slope) post-treatment compared with the remaining five patients (p<0.001). One patient had a partial PSA response (>50% reduction of PSA) of 7-month duration. GVAX cancer immunotherapy was generally well tolerated, with self-limited injection site reactions, and mild flu-like symptoms being the most frequently reported side effects. In addition to clinical activity, the publication reported immunologic findings confirming that GVAX immunotherapy for prostate cancer resulted in the induction of immune responses as evidenced by the formation of antibodies directed against prostate cancer cells.

Cell Genesys has completed five Phase 1 and Phase 2 clinical trials of GVAX immunotherapy for prostate cancer in approximately 200 patients with various stages of recurrent prostate cancer, and each trial has demonstrated a favorable safety profile. The initial Phase 1 /2 clinical trial in early- stage prostate cancer described in the above publication was conducted at Johns Hopkins Oncology Center. GVAX immunotherapy treatment was administered at a fixed dose in eight weekly intradermal injections in an outpatient setting. As noted above, one patient had a partial PSA response of 7-month duration which was associated with a corresponding decline in the tumor- associated marker, carcinoembryonic antigen (CEA), as well as induction of a high titer antibody response against a prostate cancer antigen. The titer of this antibody decreased when treatment ended, and subsequent tumor progression based on a rising PSA occurred. In addition, several candidate tumor- associated antigens recognized by treatment-induced antibodies were identified in the study, including antigens reported to be involved in modulation of immune response and cancer metastases.

"While our Phase 3 clinical trials and registration strategy for GVAX immunotherapy for prostate cancer are currently focused on the treatment of advanced prostate cancer, we are pleased to also obtain these encouraging results in an earlier-stage of the disease," said Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "We believe that GVAX immunotherapy for prostate cancer may have potential for the treatment of prostate cancer at various stages of the disease and we look forward to initiation of future label-expansion studies."

GVAX immunotherapy for prostate cancer is currently being studied in two Phase 3 clinical trials expected to enroll approximately 1200 patients with metastatic hormone-refractory prostate cancer (HRPC), comprising one of the largest Phase 3 clinical programs ever conducted in men with advanced prostate cancer. The first trial (VITAL-1) is enrolling chemotherapy naпve, asymptomatic patients without cancer-related pain and will compare GVAX cancer immunotherapy to Taxotere chemotherapy plus prednisone. The second trial (VITAL-2) is enrolling patients who are symptomatic with cancer-related pain and will compare GVAX cancer immunotherapy plus Taxotere to Taxotere plus prednisone. Each Phase 3 trial is expected to enroll 600 patients and is designed to demonstrate a survival benefit compared to Taxotere plus prednisone. Cell Genesys received Special Protocol Assessments (SPA) from the FDA for each of the VITAL-1 and VITAL-2 Phase 3 studies as well as Fast Track Status for the product itself.

The company's ongoing Phase 3 program is supported by the median survival results from two, independent, multi-center Phase 2 clinical trials in approximately 115 patients that are not only consistent with each other, but also compare favorably to the previously published median survival of 18.9 months for metastatic HRPC patients treated with Taxotere(R) (docetaxel) chemotherapy plus prednisone, the current standard of care. The Phase 3 program is designed to confirm this potential survival benefit for GVAX immunotherapy for prostate cancer.

Cell Genesys' GVAX cancer immunotherapies are whole-cell products which are designed to present the immune system with a broad spectrum of tumor antigens and stimulate an immune response against the patient's tumor. GVAX immunotherapy for prostate cancer is comprised of two prostate cancer cell lines that have been modified to secrete GM-CSF (granulocyte-macrophage colony stimulating factor), an immune stimulatory hormone which plays a key role in stimulating the body's immune response, and then irradiated for safety. GVAX cancer immunotherapy for prostate cancer is being developed as a non patient- specific, "off-the-shelf" pharmaceutical product.

Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms -- GVAX(R) cancer immunotherapies and oncolytic virus therapies. Ongoing clinical trials include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2 trials of GVAX immunotherapy for pancreatic cancer and leukemia, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer. Cell Genesys continues to hold an equity interest in its former subsidiary, Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, CA and has its principal manufacturing operation in Hayward, CA. For additional information, please visit the company's website at http://www.cellgenesys.com.

Statements made herein about the company, other than statements of historical fact, including statements about the company's progress, results and timing of clinical trials and preclinical programs and the nature of product pipelines are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of clinical trials and research and development programs, the regulatory approval process for clinical trials, competitive technologies and products, patents, continuation of corporate partnerships and the need for additional financings. For information about these and other risks which may affect Cell Genesys, please see the company's Annual Report on Form 10-K for the year ended December 31, 2005 filed on March 13, 2006 as well as Cell Genesys' reports on Form 10-Q and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The company assumes no obligation to update the forward-looking information in this press release.

Cell Genesys, Inc.
http://www.cellgenesys.com/