Guilford Announces Start of Phase II Study in Parkinson's Disease and Receipt Of New Patent Covering Neuroimmunophilin Ligands
BALTIMORE, Aug 7, 2000 /PRNewswire via COMTEX/ -- Guilford Pharmaceuticals (Nasdaq: GLFD chart, msgs) announced today that its partner, Amgen Inc. (Nasdaq: AMGN chart, msgs), has commenced a Phase II clinical trial to evaluate the safety and efficacy of neuroimmunophilin ligands in the treatment of patients with Parkinson's disease. Neuroimmunophilin ligands are orally-active drugs, which have been shown to cross the blood-brain barrier and may be useful for treating a variety of neurodegenerative disorders.
"We are extremely pleased with the progress Amgen has made in the clinical development of our neuroimmunophilin ligands," commented Dr. Craig R. Smith, President and Chief Executive Officer. "Neuroimmunophilin ligands represent a potentially exciting new development in the treatment of neurodegenerative diseases, and the initiation of a major Phase II trial for Parkinson's disease is an important milestone for both companies."
The Phase II clinical trial is a randomized, multicenter, double-blind, placebo-controlled study to evaluate the safety and efficacy of neuroimmunophilins in the treatment of patients with Parkinson's disease. Previous clinical studies in healthy volunteers demonstrated that neuroimmunophilins appeared to be safe and well tolerated at the doses and durations of administration evaluated.
Guilford also announced today the issuance of a patent that relates to this technology. The issued patent, U.S. Patent No. 6,080,753, was granted to Johns Hopkins University and is licensed to Guilford. The patent covers "stimulating growth of damaged neurons in patients suffering from Alzheimer's disease, Parkinson's disease or physical damage to the spinal cord" with a compound "having an affinity for FKBP".
"Guilford is committed to pursuing strong patent protection for its discoveries," commented Dr. Smith. "Combined with the previous patents we've obtained in this field, we believe the new patent will add to our strong intellectual property position."
About Neuroimmunophilins
In 1990, scientists led by Dr. Solomon Snyder, Director of the Department of Neuroscience at Johns Hopkins Medical School and a co-founder of Guilford, discovered that an immunosuppressive drug called FK-506 possessed neurotrophic activity and was able to induce nerve growth in both test tube and animal experiments. After licensing the rights to this technology to Guilford, our scientists designed a series of novel, proprietary drugs, called neuroimmunophilin ligands, which possessed the neurotrophic properties of FK-506, without any undesired immunosuppressive activity.
Since this initial discovery, Guilford's neuroimmunophilin ligands have demonstrated neurotrophic activity in a number of animal models of Parkinson's disease and other acute and chronic neurological diseases and conditions. Results from some of these studies have been published in The Proceedings of the National Academy of Sciences and Nature Medicine.
In 1997, Guilford partnered with Amgen to develop, manufacture and market FKBP-neuroimmunophilin ligands for up to ten therapeutic indications including, Parkinson's disease, Alzheimer's disease, traumatic brain and spinal cord injuries and ALS.
About Parkinson's disease
More than one million people in the United States have been diagnosed with Parkinson's disease. Parkinson's is a progressive disease of the central nervous system, which clinically manifests itself in reduced muscle movement and control. Symptoms may include muscle rigidity, tremors, difficulty speaking and walking. Untreated, the disorder can progress to severe disability or even premature death.
Guilford Pharmaceuticals Inc. is a biopharmaceutical company engaged in the development of polymer-based therapeutics for brain cancer and other cancers, and novel products for the treatment of neurological diseases, including Parkinson's disease, Alzheimer's disease, stroke, head trauma, spinal cord injuries, multiple sclerosis, and peripheral neuropathies. |
