February 7 2011, BUFFALO, NY — The nation’s first FDA-approved cancer treatment vaccine, Provenge (sipuleucel-T), is being offered for the first time in Western New York at Roswell Park Cancer Institute (RPCI). The vaccine is designed for men with advanced prostate cancer who have limited treatment options and who meet eligibility requirements.
Category > Immunotherapy
“These results confirm the clinical value of Provenge to prolong survival in patients with advanced prostate cancer,” said Dr. Philip Kantoff, head of the prostate cancer program and chief of the division of solid tumor oncology at the Dana-Farber Cancer Institute and Harvard Medical School, and a principal investigator of the Provenge study, in a statement.
“We’ve been waiting a long time for a drug that is well tolerated and that gives men with advanced prostate cancer another option,” said Christopher Amling, chief of urology at Oregon Health & Science University, Portland, Ore., who wasn’t involved with the study.
A four part interview with Hy Levitsky M.D., professor of oncology and tumor immunology at Johns Hopkins Medical School and co-inventor GVAX anti-cancer vaccine, is posted on Dendreon Investor Village website.
Interview conducted by rufustoehee, a dentist and Dendreon investor, published 4/22/2009.
By way of introduction, Dr Levitsky’s bio is posted alphabetically downpage among those of other speakers at Cancer Immunology & Immunotherapy 2008: From Discovery to Development to Drug.
EXCERPTS FROM INTERVIEW
Conversation with Dr. Levitsky Part 1
“. . . . how this impacts on the field of tumor immunology, I feel it will very much depend on the nature of the data they present, assuming for the sake of discussion, that this is an unequivocal and unambiguous win, then I think it will have a very significant impact. Number one, I think that unless there are aspects to this that have not been made public, I think the FDA would in this instance need to move it forward in the approval process and I think that how it ultimately gets integrated into clinical practice will be a fascinating thing to watch.
“. . . . It is important to acknowledge that tumor response is a surrogate endpoint. It is a surrogate endpoint for perhaps 2 other endpoints that might be more meaningful. One is overall survival which is the gold standard and the other perhaps is the quality of life. No one can argue that those two things have sort of the paramount importance where as to an objective 50% or greater reduction in the mean diameter of all measurable tumor masses is an interesting yard stick, but it is only a yard stick.”
Today’s New York Times reports that two groups of scientists have independently made major discoveries about the immune system. One group is led by Allan Bradley and Martin Turner in England and the other by Klaus Rajewsky at Harvard Medical School.
“These findings demonstrate the importance of this level of control in the immune system and will lead immunologists to rethink how the immune system works,” said Dr Martin Turner, Head of the Laboratory of Lymphocyte Signalling and Development at the Babraham Institute.
According to today’s issue of the journal Science, Friday Apriil 27, the discoveries number not just 2 but 4:
In a flurry of papers, three of which appear on pages 575, 604, and 608 of this issue of Science, four independent groups have for the first time deleted mouse genes for microRNAs, RNA molecules that can modulate gene behavior, with profound effects.
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
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.”