Guest guest Posted February 7, 2011 Report Share Posted February 7, 2011 Passing on as an FYI. Even with as much as I read on PCa, I must admit I've never heard of the drug. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Feb. 7, 2011 (GlobeNewswire) -- SAN DIEGO, Feb. 7, 2011 (GLOBE NEWSWIRE) -- Harbor BioSciences, Inc. (OTCBB:HRBR), a biopharmaceutical company developing novel therapeutics for the treatment of cancer, metabolic and inflammatory diseases, today announced it is closing the clinical sites of its U.S.-based Phase I/IIa clinical trial with Apoptone® (HE3235) for castration resistant prostate cancer (CRPC) – also referred to as hormone resistant prostate cancer. The final statistics for the study will be generated after all sites have been closed and the database is locked. The results are not expected to change significantly from the company's September 2010 update. The Phase I/IIa data, which will include the final statistical analysis, will then be transferred to the China State Institute of Pharmaceutical Industry (CIPI), Harbor BioSciences' development partner. That partnership was announced on January 19, 2011. Apoptone, a novel steroid analog of a testosterone metabolite, has been found to induce cell death (apoptosis) in prostate tumors. The dose-response study was designed to determine safety, maximum tolerated dose and biological activity of Apoptone in both taxane-resistant and chemotherapy-naïve patients with CRPC. The study was conducted with the Prostate Cancer Clinical Trial Consortium (PCCTC) and other clinical sites. Harbor BioSciences recently received a patent for the use of Apoptone in treating breast and prostate cancer: U.S. Patent No. 7,863,261; and patent applications are pending in various foreign countries. Patent applications for formulations and solid-state forms of the compound are also pending. A total of 68 patients were treated with Apoptone at doses ranging from 10 to 700 mg per day. The drug was judged to be safe and well tolerated. Antitumor effects were noted in all doses studied including the lowest dose. In some individuals, there have been favorable responses in bone scans ranging from decrease of tracer uptake to resolution of some bone tumors; and in one patient there was a sustained partial response (RECIST) for greater than six cycles following the first evaluation at cycle two. Data, analyzed using standard methodology for prostate cancer research, demonstrate an effect on circulating tumor cells (CTC).-- Emerson www.flhw.orgEvery 2.25 minutes a man is diagnosed with prostate cancer.Every 16.5 minutes a man dies from the disease. Quote Link to comment Share on other sites More sharing options...
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