Neotherapuetics possibly has a breakthrough drug - NEOT Message Board

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Biotech / Medical : Neotherapuetics possibly has a breakthrough drug - NEOT

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Jan 17 4:00 PM EST

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To: Icebrg who wrote (202)	9/22/2003 4:52:01 AM
From: Icebrg	of 204

GPC Biotech Receives Fast Track Designation for Anticancer Drug Candidate Satraplatin from U.S. FDA Monday September 22, 1:45 am ET MARTINSRIED/MUNICH, Germany and U.S. Research Facilities in WALTHAM/BOSTON, Mass. and PRINCETON, N.J., Sept. 22 /PRNewswire-FirstCall/ -- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX 30) today announced that the U.S. Food and Drug Administration (FDA) has granted "fast track" designation to satraplatin as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer (HRPC). The FDA's fast track programs are intended to facilitate the development and expedite the review of drugs to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The "fast track" designation enables a company to do a rolling submission, submitting sections of the NDA (New Drug Application) as they become available. A multicenter, global, randomized study evaluating satraplatin plus prednisone versus prednisone alone as a second-line chemotherapy regimen for treating patients with HRPC is expected to begin soon. The primary endpoint of the trial will be the time to disease progression. The study's objectives also will include the evaluation of pain control and survival, as well as an assessment of drug safety in this patient population. "The receipt of fast track designation from the FDA represents another important step forward in our strategy to advance satraplatin through the clinical/regulatory process as rapidly as possible," said Marcel Rozencweig, M.D., Senior Vice President, Drug Development of GPC Biotech. "This fast track designation recognizes the need for new, efficacious therapies in treating hormone-refractory prostate cancer patients who have failed one chemotherapeutic regimen. We will continue to work closely with the FDA throughout the trial process."

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