By Lisa Seachrist

Washington Editor

Baltimore-based Guilford Pharmaceuticals Inc. said Monday that marketing partner Amgen Inc. had begun Phase II clinical testing of neuroimmunophilin ligands as a treatment for Parkinson's disease.

The Phase II test is a randomized, multicenter, double-blind, placebo-controlled study evaluating the safety and efficacy of the orally active compounds in patients with Parkinson's. Thousand Oaks, Calif.-based Amgen isn't detailing the length of the study or the number of patients likely to be involved; however, these types of trials typically study patients for 12 to 18 months.

"This is an important step for us," said Stacey Jurchison, director of corporate communications at Guilford. "Previous human studies of various doses have shown the drug is safe and well tolerated. We are excited to be testing the drug in Parkinson's patients. Amgen is a very strong partner for us."

Neuroimmunophilin ligands are small-molecule drugs that cross the blood-brain barrier and induce nerve growth. The compounds bind to immunophilins, intracellular proteins found in the brain and central nervous system. The proteins are involved in nerve cell growth, but their exact role isn't well defined.

The neuroimmunophilin ligands were derived from the immunosuppressive drug FK-506, which targeted immunophilins - specifically FK binding protein - on immune cells. Guilford co-founder Solomon Snyder, director of the Department of Neuroscience at Johns Hopkins Medical School, discovered FK-506 not only damped down immune responses but also stimulated nerve growth.

Guilford scientists designed a series of neuroimmunophilin ligands possessing the neurotrophic proprieties of FK-506 without the immunosuppressive properties. Those molecules served as the basis for a 1997 development and marketing deal with Amgen worth up to $465.5 million. (See BioWorld Today, August 22, 1997, p. 1.)

In addition to announcing the beginning of a Phase II program for the compounds, the company also announced Johns Hopkins University had been granted a patent covering the use of neuroimmunophilin ligands for stimulating the growth of damaged neurons in patients suffering from Alzheimer's disease, Parkinson's disease or physical damage to the spinal cord. JHU has licensed this patent to Guilford.

Guilford's stock (NASDAQ:GLFD) closed Monday at $19.25, up $2.281. Amgen's stock (NASDAQ:AMGN) closed at $72.125, up $3.