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Acorda Therapeutics Announces Investigational New Drug Application Accepted for GGF2 for Treatment of Heart Failure
Investigational New Drug Application (IND) Filed on March 19, 2010 Phase 1 Clinical Trial Expected to Begin in Mid-2010 in Heart Failure Patients HAWTHORNE, N.Y., Apr 20, 2010 (BUSINESS WIRE) --Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced plans to initiate a Phase 1 single-dose clinical trial of the Company's compound, Glial Growth Factor 2 (GGF2), in patients with heart failure in mid-2010, based on an IND filed with the U.S. Food and Drug Administration (FDA) on March 19, 2010. GGF2 has been shown to protect heart muscle and restore cardiac function in preclinical models of heart failure, myocardial infarction and cardiotoxicity.
"This IND is the result of a number of years of research, planning and collaboration. Acorda's clinical, preclinical and regulatory teams have done an outstanding job designing a development program to explore the potential of GGF2 in heart failure," said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. "GGF2 may represent a new approach to treating heart failure, and may also have potential applications in neurology, which we hope to investigate in subsequent clinical studies."
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 central nervous system 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 resulting from heart disease or injury. Existing medications for heart failure primarily aim to modify the workload of the heart, rather than promote ventricular repair.
Acorda submitted an IND for GGF2 as a therapy for heart failure, based on extensive research by the Company and both independent and collaborative academic centers. Acorda is also continuing preclinical studies of potential neurology indications for GGF2 and other neuregulin growth factors. |