This is the text of Howard Scher M.D.’s letter to FDA about the March 29th advisory committee hearing on Dendreon’s vaccine Sipuleucel-T (Provenge):

I am writing to express concerns about the recent review of Sipuleucel-T at the FDA Advisory Meeting on March 29, 2007. These concerns are: a recommendation for approval based on data that fall short of the regulatory requirements; an inadequate statistical construct to determine definitive benefit; incomplete data on product safety; and what appear to be different criteria for approval by two Advisory Committees to the Agency.

A week before the FDA advisory committee meeting on Dendreon’s Provenge, investment analyst Adam Feuerstein predicted that if Provenge is approved it could generate over $100 million in sales in 2008. Feuerstein’s estimate is based on a projected price of $30,000 per year per course of the vaccine. His model assumes increasing numbers of men living with (and dying of) metastatic androgen independent refractory prostate cancer (AIPrC) over the next decade.

For an overview of 3 main types of immunotherapies, or therapeutic vaccines, in trials for prostate cancer see Round Table meeting held on April 1, 2005 in Boston, Massachusetts. This meeting was paid for by Cell Genesys. Contents (with charts and explanatory cartoons):

FUNDAMENTALS OF TUMOR IMMUNOLOGY
RELEVANT TO PROSTATE CANCER IMMUNOTHERAPY
Charles G. Drake, MD, PhD
The Sidney Kimmell Comprehensive Cancer Center Johns Hopkins Medical Center

POXVIRUS VACCINES
Robert S. DiPaola, MD
The Cancer Institute of New Jersey

TUMOR CELL VACCINES
Jonathan Simons, MD
Emory University School of Medicine

DENDRITIC CELL VACCINES
Johannes Vieweg, MD
Duke University Medical Center

Cell Genesys says the 22 patients in their Phase 2 trial of GVAX who received the most effective tolerable dose — “the dose that is comparable to that being employed in the company’s ongoing Phase 3 program”– reached median survival of 35.0 months.

This trial enrolled men with hormone refractory prostate cancer. Cell Genesys previously reported final median survival results from its first multi-center Phase 2 trial of GVAX as 26.2 months.

“The survival results from the two, independent multi-center Phase 2 clinical trials compare favorably to the previously published median survival of 18.9 months for metastatic hormone-refractory prostate cancer patients treated with Taxotere(R) (docetaxel) chemotherapy plus prednisone, the current standard of care for these patients. The company’s ongoing Phase 3 program is designed to confirm this potential survival benefit for GVAX immunotherapy for prostate cancer.”

Read the full press release

Nicholas DeWolf, inventor, computer expert and philosopher, died Sunday April 12 in a hospital in Aspen, CO age 77 of complications from a stroke and prostate cancer.

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