NIH Selects Guilford Pharmaceuticals' GPI 1485 For Clinical Study of Parkinson's Disease
Monday December 16, 8:30 am ET
Novel Neuroimmunophilin Ligand Selected for Comprehensive Investigation of Neuroprotection
BALTIMORE, Dec. 16 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc. (Nasdaq: GLFD - News) announced today that the National Institutes of Health (NIH) plans to test the Company's neuroimmunophilin ligand, GPI 1485, in a comprehensive clinical investigation of novel neuroprotective therapies for Parkinson's disease. The clinical program, which will study up to six promising compounds, including GPI 1485, will be funded by the National Institute of Neurological Disorders and Stroke (NINDS), a division of the NIH. The studies will be carried out by NIH in cooperation with coordinating centers at the University of Rochester and the Medical University of South Carolina, and up to 42 participating sites in the United States and Canada. The NINDS selected GPI 1485 based upon strong, consistent preclinical data in animals and preliminary data from a recently completed Phase II clinical trial.
"We're very honored that GPI 1485 was chosen by the NINDS as one of a select few investigational new drugs to be evaluated in its clinical protocol for Parkinson's disease," remarked Craig R. Smith, M.D., Chairman and Chief Executive Officer of Guilford. "The NINDS decision underscores the significance of recent data from a Phase II evaluation, which suggest that GPI 1485 administered orally for six months may retard the loss of dopamine transporters, a marker of disease progression, in patients with Parkinson's disease. We look forward to the results of the NINDS investigation, as well as our own Phase II trial, which has already begun."
NINDS, through its investigators, plans to conduct a series of studies designed to evaluate the treatment benefit of GPI 1485. Each pilot study will focus on a single agent and will determine if the agents appear to slow the rate of progression of Parkinson's disease, and if it is promising enough to enter Phase III studies. Combinations of agents may also be tested in the future. NINDS and its investigators are currently developing the protocol for these studies. It is anticipated that the studies will begin in 2003. Guilford will be responsible for supplying active drug and placebo for the studies. If the results of the initial pilot studies of GPI 1485 appear promising, NINDS may consider Phase III clinical testing. All financial and other obligations related to the conduct of these studies will be supported by NINDS. Further, NINDS and its investigators will provide Guilford access to data from the study, and will cooperate with Guilford in meeting Food and Drug Administration (FDA) requirements for submission of the results of the trial as part of a broader filing, should this occur.
"We're very pleased to undertake this comprehensive clinical investigation of novel neuroprotective therapies for Parkinson's disease," remarked Bernard Ravina, MD, Program Director, Clinical Trials, NINDS. "Parkinson's disease is a chronic, progressive, debilitating disorder which presently affects over one million Americans. Current therapies for the disease focus on controlling or minimizing the symptoms. They have not been shown to impact disease progression, however, we're hopeful that this important collaborative effort will elucidate new potential treatments for the benefit of patients with Parkinson's disease."
About GPI 1485 and Neuroimmunophilin Ligands
GPI 1485 is an investigational new drug that belongs to a class of compounds called neuroimmunophilin ligands. Neuroimmunophilin ligands are small molecules, which in preclinical experiments, have been shown to repair and regenerate damaged nerves without affecting normal, healthy nerves. Neuroimmunophilin ligands may have application in the treatment of a broad range of diseases, including: Parkinson's disease, spinal cord injury, brain trauma, and peripheral nerve injuries including post-prostatectomy erectile dysfunction.
Guilford Pharmaceuticals Inc. is a fully integrated pharmaceutical company that discovers, develops and markets novel pharmaceutical products targeting the hospital and neurological markets.
Contact: Guilford Pharmaceuticals Inc.
Stacey Jurchison 410.631.5022
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