>>SAN DIEGO, Dec. 6 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE - News) today reported interim clinical data from a Phase 2 trial of GVAX® cancer vaccine for acute myelogenous leukemia (AML). Patients with newly diagnosed leukemia were treated with chemotherapy, and if responsive, subsequently received autologous bone marrow stem cell transplantation and GVAX® leukemia vaccine. The preliminary findings of this trial indicate that vaccine therapy is well tolerated and may reduce residual leukemic cells that persist after chemotherapy as indicated by decreased levels of WT-1, a leukemia-associated genetic marker, which is detectable in over 95 percent of patients with active AML. The trial is being conducted by Ivan Borrello, M.D., Hyam I. Levitsky, M.D. and colleagues at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and was reported today at the American Society of Hematology (ASH) Annual Meeting in San Diego, CA, by Dr. Borrello (ASH Abstract #1791).
The Phase 2 trial was conducted at four leukemia bone marrow transplant centers in the United States and enrolled 54 patients. To date, 17 patients have received at least one GVAX® vaccination following a successful response to chemotherapy and stem cell transplantation. Twelve of these 17 patients had detectable WT-1 levels in their bone marrow following chemotherapy suggesting persistent leukemic cells, and in eight of these patients (67 percent), WT-1 levels declined after vaccination. In addition, in 13 of the 17 patients, WT-1 was detected in peripheral blood cells, and in eight of these patients (61 percent), there were post-vaccination declines in WT-1. Additionally, GVAX® leukemia vaccine was shown to induce both a cellular and antibody-based immune response against leukemia cells in the majority of patients tested to date. There have been no serious side effects reported to date with the experimental GVAX® leukemia vaccine therapy.
"We are encouraged by the initial clinical activity reported today from our Phase 2 study of GVAX® vaccine in acute leukemia as well as the updated results from a related Phase 1/2 study in multiple myeloma," stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "These results in hematologic malignancies further demonstrate the potential broad applicability of GVAX® cancer vaccines for multiple types of cancer."
In related news, updated data from the Phase 1/2 trial of GVAX® myeloma vaccine were also presented today at the ASH Meeting (ASH Abstract #1794). Patients with advanced multiple myeloma were treated with chemotherapy, and if responsive, subsequently received autologous bone marrow stem cell transplantation and GVAX® vaccination. The trial enrolled 20 patients, and 14 patients received at least one GVAX® vaccination. Combination therapy with transplantation and GVAX® vaccine resulted in three complete responses, five partial responses, five patients with stable disease and one patient with progression. Importantly, three of the responders progressed after transplantation and then demonstrated antitumor activity attributed to vaccination as measured by reductions in the myeloma-associated circulating protein (M-spike) of 92 percent, 37 percent and 25 percent. Treatment with GVAX® myeloma vaccine to date has been safe and well tolerated.
The form of GVAX® vaccine used in both the leukemia and myeloma clinical trials is a non patient-specific GVAX® product manufactured at Cell Genesys that is mixed at the treatment center with the patient's irradiated tumor cells that were collected prior to chemotherapy. Cell Genesys believes that this product (sometimes referred to as "bystander GVAX®") could potentially be developed as an off-the-shelf pharmaceutical for use in multiple types of hematologic malignancies. Future manufacturing of the product would be expected to occur at the company's plant in Hayward, California, one of three Cell Genesys manufacturing facilities with Phase 3 and market launch production capabilities.
Clinical trials of GVAX® cancer vaccines are under way for multiple types of cancer including prostate cancer, lung cancer, pancreatic cancer, leukemia and myeloma. Cell Genesys' GVAX® cancer vaccines are whole-cell vaccines which are designed to stimulate an immune response against the patient's tumor. The vaccines are comprised of tumor cells that have been irradiated and genetically modified to secrete GM-CSF (granulocyte-macrophage colony stimulating factor), an immune stimulatory hormone which plays a key role in stimulating the body's immune response to vaccines.<<
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