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

To: tuck who wrote (1159)	11/27/2001 9:35:26 AM
From: tuck	Read Replies (1) \| Respond to of 1298

>>FOSTER CITY, Calif., Nov. 27 /PRNewswire/ -- Cell Genesys, Inc. (Nasdaq: CEGE - news) today announced that it is initiating a multicenter Phase II clinical trial of GVAX® cancer vaccine for acute myelogenous leukemia (AML), the most common form of adult leukemia. The trial will evaluate the safety and efficacy of GVAX® vaccine in combination with bone marrow transplantation in approximately 50 patients with newly diagnosed AML. The trial, which will be conducted at five leading transplant centers in the United States, is strongly supported by preclinical data demonstrating that GVAX® cancer vaccine in combination with bone marrow transplantation significantly prevented relapse of leukemia and increased the overall survival. These preclinical data were published in a May 2000 issue of the journal, Blood, the official journal of the American Society of Hematology. ``This new clinical trial is one of seven cancer clinical programs now ongoing at Cell Genesys. We are fortunate that our company is in a strong financial position which enables us to conduct multiple clinical trials in parallel in an effort to expeditiously advance our products to the market,'' stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. ``GVAX® cancer vaccines have demonstrated promising results in multiple types of cancer, and we believe that the systemic antitumor immune response produced by GVAX® cancer vaccines could be particularly beneficial in patients with leukemia following chemotherapy and stem cell transplantation.'' Autologous (patient-specific) peripheral stem cell transplantation is currently being used to treat hematologic cancers to overcome the bone marrow toxicity of high dose chemotherapy, and while it cures some patients with AML, the majority still relapse and die from their disease. In the GVAX® vaccine trial for AML, patients will be treated with chemotherapy to induce a complete remission and will then be vaccinated before and after autologous peripheral stem cell transplantation. The form of GVAX® vaccine used in this trial will be a non patient-specific GVAX® product which will be mixed with the patient's irradiated leukemia cells collected prior to chemotherapy to create a patient-specific vaccine. The goal of GVAX® vaccine therapy in this setting is to stimulate an immune response directed against the patient's own tumor and enhance the anti-leukemia activity of standard chemotherapy and transplantation. Cell Genesys believes that this type of GVAX® product, which is also currently being evaluated in separate Phase I/II trials for multiple myeloma and lung cancer, can be used to develop patient-specific vaccines for multiple types of malignancies. Preclinical studies supporting the new Phase II trial were published in a May 2000 issue of the journal, Blood. Cell Genesys collaborators at Johns Hopkins University reported that in animal studies of acute leukemia, GVAX (R) cancer vaccine could be administered following bone marrow transplantation and significantly prevented tumor relapse thereby increasing the therapeutic benefit of transplantation. Tumor-free survival rates were approximately 80 percent in animals receiving the combination of GVAX® vaccine and transplantation, 40 percent in animals receiving vaccination alone and zero percent in animals receiving neither treatment. Additionally, GVAX® vaccination resulted in the sustained production of an expanded population of tumor-specific immune cells, thereby redirecting the immune system to recognize and destroy tumor cells. Multiple clinical trials of GVAX® cancer vaccines are currently under way in several types of cancer including lung, prostate, pancreatic, multiple myeloma and leukemia. GVAX® cancer vaccines are comprised of genetically modified, irradiated tumor cells which produce an immune hormone called granulocyte-macrophage colony stimulating factor (GM-CSF) which stimulates an antitumor immune response directed against the patient's tumor. Cell Genesys is currently testing both patient-specific and non patient-specific GVA X® vaccines since it believes that different types of cancer may benefit from treatment with one or the other type of vaccine. Non patient-specific vaccines, which can be developed as ``off-the-shelf'' pharmaceuticals, are currently being tested in patients with prostate and pancreatic cancer, whereas patient-specific vaccines are being tested in patients with lung cancer, myeloma and leukemia. GVAX® cancer vaccines have demonstrated antitumor activity in all human clinical trials that data have been reported from to date and have been safely administered to more than 350 patients with a very favorable side effect profile compared to other cancer treatments.<< snip Cheers, Tuck