Acorda Therapeutics Announces Initiation of Phase I Clinical Trial in Patients With Heart Failure
Acorda Therapeutics, Inc. recently announced 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 I 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, MD, PhD, 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.
Acorda Therapeutics is a biotechnology company developing therapies for multiple sclerosis, spinal cord injury, and related nervous system disorders. The company is commercializing and marketing AMPYRA (dalfampridine) Extended Release Tablets, 10 mg, in the Unites States. AMPYRA is a potassium channel blocker approved as a treatment to improve walking in patients with multiple sclerosis (MS); this was demonstrated by an improvement in walking speed. AMPYRA was developed using Elan’s Matrix Drug Absorption System (MXDAS) technology and is manufactured by Elan based on a supply agreement with Acorda. The company also markets ZANAFLEX CAPSULES (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The pipeline includes a number of products in development for the treatment, regeneration, and repair of the spinal cord and brain.
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