Cell Genesys Provides Update on Clinical Program for GVAX Immunotherapy for Leukemia

Three New Clinical Trials Under Way

11-May-2007

Cell Genesys, Inc. reported that three new clinical trials for GVAX immunotherapy for leukemia are now under way in collaboration with the Johns Hopkins Sidney Kimmel Cancer Center. The new trials are based on encouraging results in an initial Phase 2 study of the product in patients with chronic myelogenous leukemia (CML) and include:

- A Phase 2 randomized trial in 56 patients with CML who have persistent molecular evidence of disease following Gleevec(R)(imatinib) therapy that will compare the combination of GVAX plus continued Gleevec to the combination of interferon-alpha, GM-CSF plus continued Gleevec with respect to the levels of bcr-abl, a well-established marker of residual leukemia. The study will also compare the ability of each combination therapy to permit a carefully monitored discontinuation of therapy in those patients who achieve a sustained complete disappearance of bcr-abl in order to determine the potential for disease eradication.

- An extension study of the initial Phase 2 trial in 19 patients with CML that will evaluate the efficacy of a second course of GVAX with respect to inducing a complete disappearance of bcr-abl in the 11 patients who responded to the first course of GVAX, but failed to achieve a sustained complete response.

- A Phase 1 trial in 18 patients with poor risk myelodysplastic syndrome (MDS) with or without prior chemotherapy, that will evaluate response to GVAX as measured by blood counts and transfusion requirements, cytogenetics and levels of WT-1, a marker associated with leukemia.

https://www.bionity.com/en/news/64560/cell-genesys-provides-update-on-clinical-program-for-gvax-immunotherapy-for-leukemia.html