Encouraging Results From Phase I Trial Of GVAX Cancer Vaccine.(Brief Article)

2002 JAN 9 - (NewsRx.com & NewsRx.net) -- Cell Genesys, Inc., reported that a Phase I clinical trial of GVAX cancer vaccine in patients with refractory or relapsed acute myelogenous leukemia (AML) and preleukemia 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, MD, PhD, who presented the interim data December 10, 2001, at the American Society of Hematology Meeting in Orlando, Florida. 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 preleukemia 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 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, PhD, Cell Genesys. "GVAX cancer vaccines continue to demonstrate antitumor activity in multiple types of cancer, and we are ...