Acceleron and Celgene Initiate Phase 2 Study of ACE-011 to Treat Chemotherapy-Induced Anemia
News Jul 29, 2009
Acceleron Pharma, Inc and Celgene Corporation have announced the initiation of a second Phase 2 clinical study of ACE-011. This Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study designed to evaluate the potential of ACE-011 to treat chemotherapy-induced anemia in patients with metastatic breast cancer.
ACE-011 is a novel therapeutic agent that has been shown to increase levels of red blood cells and hemoglobin and stimulate new bone formation. ACE-011 works through a novel mechanism by inhibiting certain members of the TGF-beta superfamily while potentially avoiding the erythropoietin pathway.
“We are pleased to build on the robust hematologic effects observed in earlier studies of ACE-011 by initiating this Phase 2 clinical trial in breast cancer patients with chemotherapy-induced anemia,” said Matthew Sherman, M.D., Chief Medical Officer of Acceleron. “This study, along with the nearly completed Phase 2 clinical trial in patients with multiple myeloma, will provide insight into the therapeutic potential of ACE-011.”
“Our discovery of a novel class of anemia therapies comes at a critical time for cancer patients. Many of these patients suffer from an inadequate response to existing therapies or remain untreated due to safety concerns with erythropoietin-based therapies for chemotherapy-induced anemia,” said John Knopf, Ph.D., Chief Executive Officer of Acceleron.
“We are excited to be working with a pre-eminent global biopharmaceutical company like Celgene, which is experienced in maximizing the clinical and commercial potential of disease-altering compounds, to advance the development of this unique molecule, which could replenish red blood cells and has been shown to inhibit the growth and metastasis of tumors in nonclinical animal models of breast cancer.”