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Biotech / Medical : Cell Genesys (CEGE) -- Ignore unavailable to you. Want to Upgrade?

To: SemiBull who wrote (1163)	12/10/2001 9:45:33 AM
From: tuck	Read Replies (1) \| Respond to of 1298

>>FOSTER CITY, Calif., Dec. 10 /PRNewswire/ -- Cell Genesys, Inc. (Nasdaq: CEGE - news) today reported that a Phase I clinical trial of GVAX® cancer vaccine in patients with refractory or relapsed acute myelogenous leukemia (AML) and pre-leukemia has demonstrated clinical safety and the induction of antitumor immunity following GVAX® vaccination. The Phase I trial is being sponsored by the Dana-Farber Cancer Institute under the direction of Daniel J. DeAngelo, M.D., Ph.D who presented the interim data today at the American Society of Hematology (ASH) Meeting in Orlando, FL. In follow-up, Cell Genesys has recently initiated a multicenter Phase II trial of GVAX cancer vaccine in up to 50 patients with AML. The interim clinical trial data include results on five patients with AML or pre-leukemia entered on the trial to date. All five patients demonstrated a biopsy-proven immune response at the vaccine site following treatment with GVAX® cancer vaccine. Additionally, a patient whose disease had relapsed, developed a strong immune response directed against her leukemia cells and has ongoing stable disease at 22 months following treatment. As with other GVAX® clinical trials, vaccine treatment was safe and well tolerated, and no significant hematologic toxicity was noted. ``New strategies for the treatment of leukemia are greatly in need, because while many patients respond to chemotherapy, the majority of acute leukemia patients ultimately relapse and die from their disease,'' stated Dr. DeAngelo. ``We are encouraged by the results we have seen with GVAX® cancer vaccine and hope that it will provide a promising treatment option for leukemia patients in the future.'' ``These Phase I clinical data provide a further rationale for our recently initiated Phase II study of GVAX® cancer vaccine in patients with leukemia following chemotherapy and bone marrow stem cell transplantation,'' stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. ``GVAX® cancer vaccines continue to demonstrate antitumor activity in multiple types of cancer, and we are pleased to have the financial resources to advance multiple clinical trials in parallel with the goal of bringing safe and effective cancer treatments to the market as quickly as possible.'' The GVAX® vaccine evaluated in this Phase I trial was comprised of patient-specific leukemia cells that were genetically modified to secrete granulocyte-macrophage colony stimulating factor (GM-CSF), an immune stimulatory hormone, and then irradiated for safety. Patients received at least a total of six vaccine treatments administered both intradermally and subcutaneously weekly for three weeks and then every other week for a median of four months. The form of GVAX® leukemia vaccine used in the study differs from that being evaluated in the Phase II trial initiated by Cell Genesys which employs a mixture of the patient's irradiated leukemia cells and a non patient-specific GVAX® product manufactured at Cell Genesys.<< snip Cheers, Tuck