Acceleron Announces the Initiation of the Gynecologic Oncology Group Phase 2 Clinical Trial of Dalantercept (ACE-041) in Patients with Endometrial Cancer
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Phase 2 studies of dalantercept now underway in endometrial cancer and
squamous cell carcinoma of the head and neck
Cambridge, Mass. ? November 14, 2012 ? Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases, today announced that the Gynecologic Oncology Group (GOG) initiated a phase 2 study of dalantercept in patients with recurrent or persistent endometrial cancer.? Dalantercept is a novel protein therapeutic that inhibits angiogenesis by targeting the activin receptor-like kinase 1 (ALK1) pathway.? The phase 2 study will enroll approximately 52 patients with recurrent or persistent endometrial carcinoma at multiple sites in the United States. The National Cancer Institute will provide financial support for the trial through its Cancer Therapy Evaluation Program (CTEP).
?There is substantial medical need for new drugs that can effectively treat patients whose endometrial cancer has returned or persists despite prior therapy,? said Vicky Makker, M.D., Study Chair and Assistant Attending Physician-Gynecologic Medical Oncology Service, Memorial Sloan-Kettering Cancer Center. ?We are pleased to study dalantercept as a potential new therapeutic option for these patients.?
?Acceleron is excited to collaborate with the GOG to study dalantercept in patients with endometrial cancer,? said Matthew Sherman, M.D., Chief Medical Officer at Acceleron.? ?Acceleron is building a broad phase 2 clinical development program for dalantercept with studies either underway or expected to start in the near future in head and neck cancer, renal cell carcinoma, endometrial cancer and ovarian cancer.?
The open-label clinical trial is designed to measure the number of patients treated with dalantercept who survive progression-free for at least six months as well as the number of patients who have an objective tumor response after treatment with dalantercept.? The National Cancer Institute estimates that over 45,000 cases of endometrial cancer will be diagnosed in 2012.? Current treatment options include surgery, radiation, hormones, and/or chemotherapy, depending on the stage of disease.?? Dalantercept may stop the growth of endometrial cancer in patients with advanced stages of the disease by blocking blood flow to the tumors.? For additional information on this clinical trial, please visit clinicaltrials.gov, identifier NCT01642082.
About dalantercept
Dalantercept (ACE-041) is an investigational protein therapeutic that inhibits angiogenesis by preventing BMP9 and BMP10, proteins in the TGF-? superfamily, from interacting with activin receptor-like kinase 1 (ALK1), a cell-surface receptor found on proliferating vascular endothelial cells.?? Dalantercept inhibits ALK1 signaling, which is required for the development of mature, functional vasculature.? In a Phase 1 clinical study in patients with advanced-stage tumors, dalantercept was generally well-tolerated and also exhibited signs of clinical activity, including patients with objective response and prolonged stable disease.? In addition to the phase 2 study in patients with endometrial cancer, dalantercept is also in a phase 2 clinical trial for treatment of patients with advanced head and neck cancer (clinicaltrials.gov identifier: NCT01458392).
About the Gynecologic Oncology Group
The Gynecologic Oncology Group (GOG) is one of the National Cancer Institute?s (NCI) funded cooperative cancer research groups. GOG is the only group which focuses its research on women with pelvic malignancies, such as cancer of the ovary, uterus, and cervix.? The GOG has as its main objective to provide an appropriate instrument to test new ideas for prevention of female pelvic malignancies and management of patients with such malignancies. Currently over 3,300 patients are registered each year to GOG research trials. To date, GOG has completed over 300 clinical trials and contributed over 550 manuscripts to the peer reviewed medical literature.
About Acceleron
Acceleron is a privately-held biopharmaceutical company committed to discover, develop, manufacture and commercialize novel protein therapeutics for orphan diseases and cancer. Acceleron?s scientific approach takes advantage of its unique insight to discover first-in-class therapies based on the TGF-? protein superfamily. Acceleron utilizes proven biotherapeutic technologies and capitalizes on the company?s internal GMP manufacturing capability to advance its therapeutic programs rapidly and efficiently. The investors in Acceleron include Advanced Technology Ventures, Alkermes, Avalon Ventures, Bessemer Ventures, Celgene, Flagship Ventures, MPM BioEquities, OrbiMed Advisors, Polaris Ventures, QVT Financial, Sutter Hill Ventures and Venrock. For further information on Acceleron, please visit www.acceleronpharma.com.
CONTACT:
Acceleron Pharma:
Steven Ertel, 617-649-9234
Chief Business Officer
Maureen Suda (Media)
Steven Ertel, 617-649-9234
Chief Business Officer
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