Acceleron announces positive results from phase 1 study in patients with advanced ACE-041

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Acceleron Pharma, Inc., a biopharmaceutical company protein therapeutics for cancer and orphan diseases, today presents positive results from a phase 1 study of ACE-041, a novel anti-angiogenesis goal the Activin receptor-like kinase 1 (ALK1) way. Results of the study suggest that can prevent ACE-041-monotherapy tumour growth, through angiogenesis ALK1-mediated inhibition. Results were presented Research Institute at the annual Conference of the American Association of cancer research (AACR) by Johanna Bendell, m.d., of the Sarah cannon.

"I am excited, to the new anti-angiogenic agent ACE-041, present interesting data on" drug development at the Sarah Cannon said Johanna Bendell, m.d., Director of the stomach bowel cancer research and Associate Director, Research Institute. "We have tolerable dose levels identified, and have seen preliminary signs of antitumor activity." "I look forward to the further development of this agent for cancer patients."

"We are pleased with the successful completion of the ACE-041 phase 1 study that sets ALK1 as an important target for angiogenesis," said Matthew Sherman, m.d., Chief Medical Officer at Acceleron Pharma. "Based on the observed clinical efficacy and safety profile, we plan to initiate a clinical phase 2 program, ACE-041 alone and in combination with other therapies, this year to study including VEGF antagonist."

In the multiple ascending dose phase 1 clinical trial were 37 patients with advanced tumors to assess the safety, pharmacokinetics and antitumor activity of ACE-041 are treated.

Summary of the results:

-Pharmacokinetic supports profile dosing of subcutaneous injection once every three weeks.

-Light were most commonly observed side effects to moderate peripheral edema, fatigue, anemia, nausea, dyspnea, loss of appetite and headache.

-Toxicities often associated with VEGF inhibition (hypertension, proteinuria, or bleeding) were not observed.

-A patient with advanced, recurrent head and neck cancer achieved a partial response (PR) and eight patients experienced disease stabilisation (SD) > 12 weeks.

-Robust decline > 20% in tumor metabolic activity, by FDG PET imaging in 35% of patients evaluated.

Over ACE-041

ACE-041 is a recombinant receptor fusion protein that inhibits angiogenesis by preventing, that BMP9 and BMP10, proteins in the superfamily TGFß interaction with Activin receptor-like kinase 1 (ALK1), a cell surface receptor on proliferating cells found. ACE-041 inhibits ALK1 signaling, the vascular system functional development of tyres, is required. In animal studies, treatment with ACE-041 tumor angiogenesis and growth and eyepiece inhibits more worldwide. ACE-041 is for the treatment of solid tumors are advanced stage and age-related macular degeneration (AMD) developed.

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Acceleron Pharma