Interim data reported from phase II trial of GVAX vaccine.

2004 JAN 7 - (NewsRx.com & NewsRx.net) -- Cell Genesys, Inc., (CEGE) reported interim clinical data from a phase II 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% of patients with active AML.

The trial is being conducted by Ivan Borrello, MD, Hyam I. Levitsky, MD and colleagues at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and was reported at the American Society of Hematology (ASH) Annual Meeting in San Diego, California, by Borrello (ASH Abstract #1791).

The phase II 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%), 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%), 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 from our phase II study of GVAX vaccine in acute leukemia as well as the updated results from a related phase I/II study in multiple myeloma," stated Joseph J. Vallner, PhD, president and chief operating officer of Cell Genesys. "These results in hematologic malignancies further demonstrate the potential broad applicability of GVAX cancer vaccines for ...