Dendreon announced today that the FDA will accept “either a positive interim or final analysis of survival” from its ongoing Phase III randomized clinical trial of Provenge immunotherapy for androgen independent prostate cancer.

In a press release, the company said it “has received confirmation that the U.S. Food and Drug Administration (FDA) will accept either a positive interim or final analysis of survival from its ongoing IMPACT study to supplement the Biologics License Application (BLA) for PROVENGE (sipuleucel-T). This information was obtained in a recent follow up meeting with the FDA to discuss the additional clinical data required to support the licensure of PROVENGE requested by the FDA in the Complete Response Letter the Company received on May 8, 2007.”

Cougar Biotechnology’s once-daily oral drug CB7630 (abiraterone acetate), based on recently announced trial results, appears o have some efficacy at two stages of the standard treatment path for androgen independent prostate cancer — either before or after chemotherapy.

A UK Phase I/II trial of CB7630 reports positive signs among a small number of patients enrolled so far in a trial for AIPC men who have never taken chemotherapy but have taken LHRH analogues and multiple other hormonal therapies, including antiandrogens, diethylstilboestrol and dexamethasone. In addition, a Phase II trial ongoing at several US centers and in the UK indicates that CB7630 may benefit some patients who have used up Taxotere (docetaxel) chemotherapy.

CB7630 (abiraterone acetate) is reported to have “minimal toxicity” (as yet no maximum tolerated dose has been reached). Among the small numbers of patients treated so far, benefits include lowering of PSA’s, some tumor shrinkage, and some pain reduction. In one of the trials, out of “20 evaluable patients with measurable tumor lesions, treatment with CB7630 resulted in partial radiological responses (as measured
by the RECIST criteria) in 11 patients (55%), with 7 patients demonstrating ongoing stable disease and 3 patients experienced regressing bone disease.”

The company says CB7630 “has the potential to be used by both urologists who treat patients with second line hormonal therapies and by medical oncologists who treat patients in the second line chemotherapy setting…” To that end, the company chose to announce results at AACR, aiming the presentation toward oncologists, and again at AUA:

Cougar Biotechnology Announces Interim Phase II Results Confirm
Efficacy of CB7630 in Both Chemotherapy Naïve and Chemotherapy
Refractory Prostate Cancer Patients April 17 (posted May 31) 2007.

Cougar . . . Presentation of Positive CB7630 (abiraterone acetate)
Clinical Data at AUA Annual Meeting May 21 (posted May 31), 2007

For three UK and US trials ongoing see:
clinicaltrials.gov/ct/search?term=CB7630&submit=Search

PSA velocity is a predictor of prostate cancer detection in men above age 60 as well as in younger men, according to findings presented at the annual meeting of the American Urological Association. William Catalona MD and colleagues presented evidence that PSA velocity “is significantly higher in men of all ages with prostate cancer compared to those without prostate cancer,” although the measure “performed the best in young men.” “Interestingly,” Catalona’s group writes, “the median PSAV in men with prostate cancer was less than 0.75 ng/ml/year regardless of age, suggesting that this threshold may be too high. Overall, this data confirms that PSA velocity is a useful tool for prostate cancer detection.”
Full story: PSA Velocity is a Signficiant Marker of Prostate Cancer in Older Men as Well as in Younger Men May 31, 2007

Novacea, Inc. (Nasdaq: NOVC) and Schering-Plough Corporation (NYSE: SGP) today announced that they have entered into an exclusive worldwide license agreement for the development and commercialization of Asentar (DN-101). Novacea is currently conducting a large international Phase 3 trial (ASCENT-2) evaluating Asentar in 900 patients with androgen-independent prostate cancer (AIPC). Asentar is a novel, proprietary, high-dose oral formulation of calcitriol, a potent hormone that exerts its effects through the vitamin D receptor (VDR). Full story:
Novacea and Schering-Plough Enter Into Worldwide Development and Commercialization Agreement for Asentar, a Novel Treatment for Prostate Cancer

A single PSA measurement in middle age can predict diagnosis of advanced prostate cancer up to 25 years later in an unscreened population, according to research presented at the annual meeting of the American Urological Association (AUA).

Almost all advanced cancers could be found early by intense screening of at-risk patients, according to researchers from New York and Malmo, Sweden who analyzed samples taken from a population-based cohort of 21,277 men in Malmo, Sweden between 1974 and 1986 to determine whether initial PSA plasma levels correlated with future diagnosis of advanced disease.

Of the 21,277 cases, 498 men actually developed prostate cancer, and 161 suffered from advanced disease (greater than T3 or metastasis). Association between PSA levels and eventual development advanced disease was determined using conditional logistical regression. In men with a total PSA of .5, .75, 1., 1.5 and 2 ng/ml, the probability of being diagnosed with advanced disease by age 75 was 2 percent, 3 percent, 4 percent, 7 percent and 12 percent, respectively. Risk was highly concentrated, with 89 percent of advanced cancers occurring in men with the top 10 percent of PSA levels.

This finding was presented Moderated Poster Session 59 at AUA on Wednesday, May 23 , 2007.

Jim Kiefert, chair of the executive committee of US Too International prostate cancer support group, interviewed yesterday at the American Urological Association (AUA)’s annual meeting by CNBC’s pharmaceuticals reporter Mike Huckman, said some members of his support group wept when they heard FDA had delayed approval of Dendreon’s vaccine for advanced prostate cancer, Provenge. The interview with Kiefert is part of the video at this CNBC link. Meanwhile advocates are signing a petition and plan to demonstrate in Washington D.C. and hope to meet with the head of the FDA.

Lack of cancer education, writes Aria White, NNPA Special Correspondent, causes desperate deaths for African-Americans. Because of a lack of education on cancer and cancer-prevention in the African-American community, African-Americans are more likely than any other race or ethnicity to die from cancer, according to medical experts, White reports.

”The problem is that we don’t do enough of what works,” says Sanya Springfield, Ph.D., Director of the Center to Reduce Cancer Health Disparities, in an interview.

According to the National Cancer Institute (NCI), African-American men are 35 percent more likely to die from cancer than White men and African-American women are 18 percent more likely to die from cancer than White women.

Cancer death disparities are top priority at the National Cancer Institute. The NCI’s Center to Reduce Cancer Health Disparities tries to determine the cause for such health disparities in minorities.

”The difficulty lies in funding, there are plenty of models out there that work, there just aren’t enough of them,” Springfield says.

FoxNews (“Fair and Balanced”) aired Killer Bureaucracy: Why the FDA is Keeping Lifesaving Drugs from Cancer Patients May 19, 2007. Paul Gigot interviewed Dr. Scott Gottlieb. Scott Gottlieb MD, a stock analyst appointed to a top FDA job by President Bush in 2005, returned to Wall Street where he promotes Dendreon’s Provenge in his Forbes/Gottlieb Medical Technology Investor newsletter.

Timing of Androgen Deprivation Therapy and its Impact on Cancer-specific Survival after Radical Prostatectomy: A Matched-cohort Analysis (Abstract 601)

Adjuvant androgen deprivation therapy (ADT) can improve survival following radiation therapy or radical prostatectomy. Researchers from the Mayo Clinic in Rochester, Minnesota conducted a study that focused on 6,401 patients who underwent radical prostatectomy between 1990 and 1999 with node-negative prostate cancer. Patients were divided into five groups: those who underwent ADT in the adjuvant setting; those with ADT initiated at PSA greater or equal to 0.4 ng/ml, ADT initiated at PSA greater or equal to 1 ng/ml. ADT initiated at PSA greater or equal to 2 ng/ml and ADT at systemic progression. Median follow-up for the cohort was 10 years.

The study found that patients who underwent adjuvant ADT experienced improved 10-year systematic progression-free survival (95 percent vs. 90 percent) and 10-year cancer-specific survival (98 percent vs. 95 percent) compared to patients who did not undergo adjuvant ADT. The results do not dictate whether the initiation of ADT at any other stage can impact survival, although the survival advantage was found to diminish if ADT is administered farther in the disease process. These findings do, however, support the immediate use of ADT in high-risk radical prostatectomy patients while suggesting the limitations of ADT in enhancing survival after prostate-specific antigen progression.

This abstract will be presented during Podium Session 20 on Sunday, May 20 2007 starting at 3:30 p.m.

The Food and Drug Administration (FDA) is advising consumers not to purchase or use “True Man” or “Energy Max” products promoted and sold as dietary supplements throughout the United States. Both products — touted as sexual enhancement products and as treatments for erectile dysfunction (ED) — contain potentially harmful, undeclared ingredients.The products contain substances called analogs that have similar structures to active ingredients in approved prescription drugs.

The undeclared analog ingredients in True Man and Energy Max may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.