Among other things, there can be no that GPI 1485, or other neuroimmunophilin ligands
, will successfully complete clinical testing or be granted regulatory approval to be sold and marketed as pharmaceutical products in the United States or elsewhere.
Neuroimmunophilin Ligands (NILs) belong to a class of neuroprotective and neuroregenerative drugs that Guilford is evaluating for the potential treatment of central and peripheral nerve disorders.
Neuroimmunophilin ligands may have application in the treatment of a broad range of diseases, including: Parkinson's disease, brain and spinal cord injury, multiple sclerosis, and peripheral nerve injuries including post- prostatectomy erectile dysfunction.
In the NIH-supported project, The Johns Hopkins team will evaluate one of Guilford's neuroimmunophilin ligands in preclinical cell culture and animal models of sensory neuropathy, as well as clinical studies in patients with HIV-related sensory neuropathy.
Neuroimmunophilin ligands are small molecules that in preclinical experiments have been shown to be orally bioavailable, cross the blood-brain barrier, and repair and regenerate damaged nerve terminals without affecting normal nerves.
are small molecules, which in preclinical experiments, have been shown to repair and regenerate damaged nerves without affecting normal, healthy nerves.
The Phase II clinical trial of NIL-A was the first clinical evaluation of our neuroimmunophilin ligand
technology, and was an important exploratory study," continued Dr.
are small molecules that in preclinical experiments have been shown to be orally-bioavailable, cross the blood-brain barrier, and repair and regenerate damaged nerves without affecting normal nerves.
Guilford, in collaboration with Amgen, has developed a second generation neuroimmunophilin ligand
, which is currently being evaluated in a Phase II clinical study in patients with Parkinson's disease.
We are extremely pleased with the progress Amgen has made in the clinical development of our neuroimmunophilin ligands
," commented Dr.
Corporate partners include Amgen for development of neuroimmunophilin ligands
and Aventis S.
The initial studies are designed to assess the safety, tolerability and pharmacokinetic profile of neuroimmunophilin ligands
in healthy volunteers.