Jan Manarite of Raise a Voice Campaign writes:

Prostate cancer patients have been watching for the prostate cancer/Provenge story on ABC World News with Charles Gibson. I just got a call from Dr Moyad that ABC called the prostate cancer patient who was interviewed for that story, and informed him that it would air Monday night, June 4th. This appears to be a commitment. Did ABC wait for our June 4th DC rally?

A company in Hanover, Germany, Vakzine Projekt Management, reports positive clinical trial results with their therapeutic prostate cancer vaccine VPM4001. The results will be presented at the annual meeting of the American Society for Clinical Oncology (ASCO) in Chicago, USA.

A clinical phase I/II study with 30 patients completed in 2006 showed that 73% of patients suffering from advanced, hormone-resistant prostate carcinoma responded positively to the VPM4001 therapy. The primary study parameter, the PSA doubling time, was increased from 63 days to 114 days on average. This promising result has a high statistical significance (p=0.0035), the company says. PSA doubling time is a surrogate parameter well correlated to survival: higher PSA doubling times mean higher probabilities to survive a five year period. In this trial, the median survival time came to 981 days.

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

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.

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.

Seattle P-I reporter DAN RICHMAN in an article updated tonight writes:

Seattle-based Dendreon Corp. will delay releasing its much-anticipated Provenge drug to fight prostate cancer until at least next year and possibly until 2010, spokeswomen said Thursday.

Because of that delay, the company Thursday cut 15 percent of its 250-person work force, laying off the roughly 40 staffers who were preparing to begin marketing Provenge later this year, said one spokeswoman, Monique Greer, in an interview Thursday morning.

The Food and Drug Administration last week unexpectedly declined to approve Provenge, Dendreon’s only product, without more data supporting the drug’s effectiveness.

“We expect interim data in 2008, but it’s event-driven, by deaths or survival, so it could be 2010 until we have final-survival analysis,” Greer said in an interview Thursday morning. The drug will make it to the market “at the earliest in 2009, potentially,” she said.

She said the company plans to meet with the FDA in the near future and will base its next steps on the results of that meeting.

Full Story Seattled PI, Dendreon will Delay Provenge…

A site to advocate for “Provenge Now!” has been launched. Provenge is Dendreon’s immunotherapy for prostate cancer, which was approved 17-0 for safety and 13-4 for efficacy by an FDA Advisory Committee vote March 29th this year. On May 9, Dendreon announced that FDA has sent them a “Complete Response Letter,” commonly called an approvable letter, requesting more data. Dendreon CEO Mitchell Gold said “The FDA has requested additional clinical data in support of the efficacy claim.”

In today’s Wall Street Journal, Mark Thornton, M.D., Ph.D. deplores the FDA’s decision on Dendreon’s sipuleucal-T immunotherapy (Provenge vaccine). Dr. Thornton says “May 9, 2007, should be cited in the annals of cancer immunotherapy as Black Wednesday. Within an eight-hour period that day, the FDA succeeded in killing not one but two safe, promising therapies designed and developed to act by stimulating a patient’s immune system against cancer. The FDA’s hubris will affect the lives and possibly the life spans of cancer patients from nearly every demographic, from elderly men with prostate cancer to young children with the rarest of bone cancers.”