Preclinical Studies Show GGF2 Promotes Functional Recovery from Stroke with Treatment Initiated Up to Seven Days After Event
HAWTHORNE, N.Y., Oct 19, 2010 (BUSINESS WIRE) -- Acorda Therapeutics, Inc, /quotes/comstock/15*!acor/quotes/nls/acor (ACOR 27.57, -1.36, -4.70%) today announced that data from preclinical studies show that Glial Growth Factor 2 (GGF2) promoted functional recovery following a permanent focal ischemic stroke. In a series of studies, GGF2 was administered starting up to seven days after the event to explore the neurorestorative properties of this novel growth factor. These studies were recently published online in Neuropharmacology, and the paper is scheduled to appear in a future print edition of the journal. An accompanying editorial discussed the need for new approaches in stroke intervention, and the potential role that GGF2 may play in improving function after stroke, pending further preclinical and clinical studies.
In one study, GGF2 was administered one hour following a permanent middle cerebral artery occlusion (MCAO) preclinical stroke model. In a second study, GGF2 was administered starting at 1, 3 or 7 days following MCAO. Daily intravenous administration continued for 10 days in both studies, and recovery of neurological function was assessed using a series of sensory and motor tests performed one day before MCAO, and at 1, 3, 7, 14 and 21 days after MCAO. The data showed that GGF2 was effective in improving recovery of neurological function both when delivered acutely and when delivered starting up to seven days after the onset of MCAO.
"Currently, FDA-approved stroke interventions need to be administered within a few hours of the event, which limits therapy to a very small minority of people who suffer a stroke. A therapy that could promote functional recovery from stroke with a longer time window to initiate treatment would represent an important advance in care," said Anthony Caggiano, Acorda's Vice President of Preclinical Development. "GGF2 is a neurorestorative agent that is thought to work through a novel mechanism involving repair of tissue damage in both the nervous and cardiovascular systems. This approach differs significantly from neuroprotective agents that have been explored in the past as potential treatments for stroke. These data show that GGF2 can be administered effectively in preclinical models of stroke up to a week following the event. Acorda is conducting further preclinical stroke studies with GGF2, and if the data continue to show promise, we plan to advance the compound to human clinical trials in stroke, in addition to the currently planed trials in heart failure."
Acorda plans to initiate Phase 1 studies in patients with heart failure based on an Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (FDA) in March 2010. The company is also pursuing preclinical studies in other cardiac and neurological applications for GGF2 and other neuregulin growth factors.
About GGF2
GGF2, a 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.
Acorda submitted an IND for GGF2 as a therapy for heart failure in March 2010, based on extensive research by the Company and both independent and collaborative academic centers. 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 is also continuing preclinical studies of potential cardiac and neurology indications for GGF2 and other neuregulin growth factors.
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