NEWS & COMMENTS

    PROHOST    FILTER

YES, IT IS HORMONE-REFRACTORY PROSTATE CANCER

And, Yes, We have a Promising Drug

   GPC BIOTECH (GPCB) and PHARMION (PHRM) announced positive topline results for the satraplatin Phase 3 registrational trial, the SPARC trial (Satraplatin and Prednisone Against Refractory Cancer). The trial was to evaluate (satraplatin plus prednisone) versus (placebo plus prednisone) as a second-line treatment in 950 patients with hormone-refractory prostate cancer (HRPC). The results were positive for progression-free survival (PFS) in a stage of prostate cancer that is considered extremely bad news with no hope showing at any horizon. We believe that satraplatin plus prednisolone results provided that hope, as the results are highly statistically significant (p<0.00001). PFS is the primary endpoint for submission for accelerated approval in the U.S. and will also serve as the primary basis for a Marketing Authorization Application (MAA) in Europe.

     Good news?

     It is excellent for both firms. The improvement in Progression-free survival in the satraplatin arm was seen equally for patients who had received prior Taxotere(R) (docetaxel), as well as those who received other types of chemotherapy treatments.

     In accordance with the recommendation of the independent Data Monitoring Board for the SPARC trial, patients who have not progressed will continue to be treated, and all patients will be followed for overall survival. With approximately half of the patients from the trial still alive, the companies currently expect to have final overall survival results in the fall of 2007, rather than the previously communicated mid-2007.

     The most common adverse reactions are mamageable as they consist of myelosuppression (bone marrow functions, such as lowered platelet count or lowered white blood cell count). Nausea, vomiting and diarrhea are mild to moderate.

      Why important?

     Because advanced hormone-refractory prostate cancer is life-threatening with no treatment available any where that can make a difference in the prognosis. At this stage of cancer patients are desperate for new treatments that can provide them hope for survival and, here we are, a drug that has scored a highly statistically significant improvement in progression-free survival.

     "Importantly, the difference in progression-free survival increases over time has been in favor of the satraplatin group," said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer of GPC Biotech. "Based on the positive data announced today, we will move forward as rapidly as possible with the FDA with the goal of completing the filing for marketing approval of satraplatin in the U.S. before the end of this year."

     There should be a celebration, not only by GPC BIOTECH and PHARMION, but by the oncologists, the patients, their relatives and friens and, of course, by investorswho picked up the stock of one, or the two firms.

READ MORE: GPC Biotech and Pharmion Announce Positive Results from the Satraplatin Pivotal Phase 3 Trial and Achievement of the Progression-Free Survival Endpoint

Prohost is independent publication providing information on biotech companies. Prohost does not accept compensation from companies that are featured or profiled. It is strongly recommended that any purchase or sale decisions to any of the featured companies be discussed with a financial advisor or broker prior to completing any such purchase or sale decision. All statements or expressions are the opinion of Prohost and are not meant to be a solicitation or recommendation to buy, sell, or hold securities. Investing in embryonic companies, micro-cap and growth securities is highly speculative and carries a high degree of risk. It is possible that an investor can lose all of his/her investment in this type of companies that are profiled. The information that Prohost relies on is either through the profiled company, news services, research reports, interviews, or other outside sources that Prohost believes are reliable. Prohost makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure of the profiled companies and accepts no responsibilities for inaccuracies or misleading content in any material supplied by those clients. There can be no assurance that future events relating to the profiled company will occur as anticipated. The information contained herein is provided as an information service only. Past performance of featured companies does not guarantee the future success of any currently featured or profiled company. We encourage our readers to invest carefully and read the investor information provided by the Securities and Exchange Commission ("SEC") and/or the National Association of Securities Dealers ("NASD"). We also strongly recommend that you read the SEC advisory to investors concerning Internet Stock Fraud, which can be found at: http://www.sec.gov/consumer/cyberfr.htm