Acceleron Announces the Initiation of Phase 2 Clinical Trial of Dalantercept (ACE-041) in Patients with Ovarian Cancer

Dalantercept Now in Four Phase 2 Studies to Treat Aggressive Cancers with Limited Treatment Options

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Acceleron Pharma, a biopharmaceutical company developing protein therapeutics for cancer and orphan disease, today announced that the Gynecologic Oncology Group (GOG) initiated a phase 2 study of dalantercept in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer. Dalantercept is a novel protein therapeutic that targets the activin receptor-like kinase 1 (ALK1) pathway and inhibits angiogenesis through a mechanism distinct from that of anti-angiogenic therapies currently used to treat various cancers. The phase 2, open-label study is chaired by Robert Burger, M.D., Director of the Women’s Cancer Center and Professor at the Department of Surgical Oncology at the Fox Chase Cancer Center in Philadelphia, Pa. Acceleron, its partners, and collaborators have now initiated seven phase 2 studies across three of Acceleron’s programs – dalantercept (ACE-041), sotatercept (ACE-011), and ACE-536 – since November of 2012.

“Dalantercept could offer a new therapeutic option for patients and we are excited to explore the potential benefits in this phase 2 study.”

“Resistance to current therapies remains a significant challenge in treating patients with advanced ovarian cancer,” said Dr. Burger. “Dalantercept could offer a new therapeutic option for patients and we are excited to explore the potential benefits in this phase 2 study.”

“We are pleased to collaborate with Dr. Burger and the GOG,” said Matthew Sherman, M.D., Chief Medical Officer at Acceleron. “The GOG has a long history of excellence in designing and running clinical trials in the field of gynecological malignancies. In addition to this clinical trial, dalantercept is now being studied in several phase 2 trials in patients with endometrial cancer, head and neck cancer, and renal cell carcinoma.”

This is the second clinical trial of dalantercept sponsored by the GOG; a phase 2 study in patients with endometrial cancer began in November, 2012. This study will treat patients with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer and determine the safety and efficacy as measured by the rate of progression-free survival at six months as well as the proportion of patients who have an objective tumor response. Ovarian cancer causes approximately 15,000 deaths and over 22,000 new cases are diagnosed in the United States each year, as estimated by the National Cancer Institute. For additional information on this clinical trial, please visit clinicaltrials.gov, identifier NCT01720173.

About Dalantercept

Dalantercept (ACE-041) is an investigational protein therapeutic that inhibits angiogenesis by preventing BMP9 and BMP10, proteins in the TGF-β 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 ovarian cancer, dalantercept is also in phase 2 clinical trials for treatment of patients with advanced head and neck cancer (NCT01458392), renal cell carcinoma (NCT01727336), and endometrial cancer (NCT01642082).

About Ovarian Cancer

Ovarian cancer is the fifth leading cause of cancer-related death among women, and is the deadliest of gynecologic cancers. Ovarian cancer is often undetected until it has reached advanced stages of the disease, when it is most difficult to treat. Globally, an estimated 225,000 patients are diagnosed with ovarian cancer and 140,000 patients die from this disease each year. Treatment through a combination of cytoreductive surgery and chemotherapy can be effective, but relapse remains common.

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-β 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.

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.