Acorda initiates enrollment in GGF2 Phase 1 clinical trial in patients with heart failure

Dec 9 2010

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the first patient has been enrolled in the first clinical trial of Glial Growth Factor 2 (GGF2). Acorda is collaborating with the Vanderbilt University Heart and Vascular Institute to conduct this Phase 1 single-dose trial in patients with heart failure.

"In preclinical models, GGF2 restored the integrity of heart muscle and improved function, which represents a novel approach to treat heart failure," said Anthony Caggiano, M.D. Ph.D., Vice President of Research and Development at Acorda. "This first clinical trial in patients with heart failure is an important step to assess the safety of GGF2 in humans and will inform the design of potential future trials."

The primary objective of this double-blind, randomized study is to evaluate the safety and tolerability of GGF2 in patients with heart failure. In this trial, participants will receive either placebo or a low dose of GGF2 administered as a single intravenous infusion. If GGF2 is well tolerated, subsequent groups will receive single infusions of higher doses.

GGF2, which is part of a family of proteins known as neuregulins, has been shown to be pharmacologically active in a number of preclinical models of cardiovascular and neurological conditions. GGF2 acts directly on heart muscle cells, or cardiomyocytes. It is believed to improve the heart's ability to contract by promoting the repair of tissue damage that results from heart disease or injury. GGF2 may offer a unique treatment strategy as preclinical studies demonstrate that GGF2 acts directly to repair cardiac muscle and improve its contractile function.

SOURCE Acorda Therapeutics