|Early results for BioSante's GVAX Prostate cancer vaccine|
|By Staff and Wire Reports|
|Monday, 05 March 2012 08:19|
While the drug development is obvisouly still early, results showed that the GVAX Prostate cancer vaccine in treating metastatic castration-resistant prostate cancer patients (mCRPC) in combination with ipilimumab (Ipi; Yervoy; BMS), resulted in 53 percent of patients achieving at least stable disease, with two patients showing clear regression of metastases. In addition, 23 percent of patients in the higher dose cohorts had confirmed partial PSA (prostate specific antigen) responses of greater than 50 percent from baseline, sccording to the company. Last week, shares of the company jumped early, but eventually sold off after BioSante said patients who were treated with the pancreatic cancer version of its GVAX therapy in an early clinical trial showed signs of improved survival.
The 28 patient Phase I study was conducted by researchers at the VU University Medical Centre in Amsterdam, Netherlands. BioSante’s Prostate cancer vaccine is made from allogeneic prostate cancer cells genetically altered to produce an immune system stimulator called GM-CSF, and irradiated to prevent cell growth. A Phase II GVAX Prostate clinical trial is anticipated to begin in 2012 at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center.
“We are very excited by the positive results of this prostate cancer study notably combined with recently reported excellent results in pancreatic cancer. This is encouraging news concerning the potential for GVAX cancer vaccines, especially when combined with other anticancer immunotherapies like Ipi, for treatment of a disease that can be so devastating for so many patients,” said Stephen M. Simes, BioSante’s president & chief executive officer.
Shares of the company have been rising steadily since its lead product, Libigel failed based on an initial analysis of data from two pivotal phase 3 efficacy trials. Biotech bloggers point out that Biosante's Bio-T testosterone gel approved earlier this month also faces significant hurdles and competition.
Video of BioSante's Presentation from a recent Cancer Immunotherapy Conference can be seen at: http://www.biobusiness.tv/investor-presentations/biosante-presentation-at-cancer-immunotherapy-conference-1548/.