CellGenesys Reports Positive Results From Phase 2 Trial of GVAX(R) Vaccine for Leukemia in Chronic Myelogenous Leukemia

VaccineReduces Molecular Evidence of Persistent Leukemia After Long-Term Gleevec(R) Therapy

14-Dec-2005

Cell Genesys, Inc.reported encouraging clinical data from a Phase 2 trial ofGVAX(R) vaccine for chronic myelogenous leukemia (CML). Nineteen CML patients with molecular evidence of persistent leukemia despite more than one year ofGleevec(R) (imatinib mesylate) therapy were treated with GVAX vaccine for leukemia while continuing to receive Gleevec. The initial findings of this trial indicate that the addition of the vaccine to Gleevec therapy has reduced persistent leukemic disease in 9 of 19 patients to date as demonstrated by a complete disappearance (five patients) or agreater than one log (90%) reduction (four patients) in bcr-abl -- a validatedgenetic marker found on the leukemic cells.

Of the remaining 10 patients, only one patient has progressed on therapy with GVAX vaccine for leukemia while the other 9 continue to be monitored forreductions in bcr-abl. Reductions of bcr-abl have been previously shown to be strongly associated with improved progression-free survival in patients with CML. The trial was conducted at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center by Dr. Hyam Levitsky, professor of Oncology Medicineand Urology, and colleagues.

The therapy of CML has improved substantially in recent years as a result of the introduction of Gleevec therapy, which is now approved for the first-line treatment of CML in chronicphase. Hematologic responses are seen routinely in the majority of treated patients but complete molecular responses,as measured by quantitative PCR for bcr-abl, occur in less than 10 percent of patients even after 12 months of therapy. Given that the reduction in bcr-abl in patients is positively associated with clinical outcome, new therapeutic strategies to eliminate persistent leukemic disease as evidenced by bcr-abl positive cells are urgently needed. Moreover, it should be noted that to date, the only therapeutic intervention shown to be capable of completely eliminating bcr-abl positive leukemic cells in the majority of patients is allogeneic bonemarrow transplantation, an intensive medical procedure with significant treatment-related mortality that may not be indicated in many patients.

https://www.bionity.com/en/news/50848/cellgenesys-reports-positive-results-from-phase-2-trial-of-gvax-r-vaccine-for-leukemia-in-chronic-myelogenous-leukemia.html