Acceleron commences dalantercept phase 2 study in metastatic renal cell carcinoma

Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases, announced the initiation of a phase 2 study of dalantercept, a novel angiogenesis inhibitor that targets the activin receptor-like kinase 1 (ALK1) pathway. The phase 2 study is a two-part, randomized study of dalantercept in combination with axitinib (Inlyta^®, Pfizer), a vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor, to treat patients with metastatic renal cell carcinoma (RCC). 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.

"Many patients with renal cell carcinoma respond to treatment with a VEGF inhibitor yet their disease subsequently progresses," said Michael B. Atkins, M.D., Deputy Director, Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center. "We are optimistic that combining two therapies with distinct anti-angiogenesis mechanisms, a VEGF inhibitor and dalantercept, an ALK1 signaling inhibitor, can provide a more effective and durable antitumor response in these patients."

"Angiogenesis is known to be a key factor in the development and progression of renal cell carcinoma" said Matthew Sherman, MD, Chief Medical Officer of Acceleron. "Dalantercept, in combination with a VEGF inhibitor, may inhibit angiogenesis more completely which could lead to improved outcomes in RCC patients. Acceleron is excited by the potential of dalantercept and is committed to a broad development program for this promising molecule."

The clinical trial is designed as two-part study in patients with metastatic renal cell carcinoma. Part 1 is a dose-escalation study of dalantercept in combination with axitinib to evaluate the safety and tolerability of the combination as second line treatment. Part 2 is an open-label, randomized study to determine whether treatment with dalantercept in combination with axitinib prolongs progression free survival (PFS) compared to treatment with axitinib alone. For additional information on this clinical trial, please visit clinicaltrials.gov, identifier NCT01727336.