ZICHRON YAAKOV, Israel - Proneuron Biotechnologies, Inc. (Ness-Ziona, Israel) is poised to start Phase I clinical trials of the company's spinal cord cell therapy for newly injured paraplegic patients following U.S. FDA approval.

"This is the FDA's first approval for a trial of a therapy aimed at regenerating nerve cells damaged by a complete spinal cord injury, a treatment that addresses a dire and major medical need," said physician researcher Adrian Harel, manager of Proneuron Biotechnologies (Israel) Ltd, the company's R&D and manufacturing subsidiary.

The clinical trial received authorization from the Israeli Ministry of Health and will be conducted at two medical centers in Israel with the FDA imprimateur.

"The enrollment of the first patient is expected to take place in the autumn," said Dr. Valentin Fulga, Proneuron's director of clinical and regulatory affairs. This study will recruit 10 newly injured patients.

The procedure for Proneuron's innovative spinal cord cell therapy was established in animal studies reported in the July 1998 edition of Nature Medicine. White blood cell macrophage subsets are removed from the injured patient's blood and processed briefly ex vivo to activate them. The activated cells are injected into the patient's spinal cord. Unactivated macro phages, which promote wound healing in most body tissues, are normally unable to enter the spinal cord in large numbers; the activation and direct administration promoted significant healing in injured animals and return of function, Michal Schwartz, professor at the Weizmann Institute of Science in Rehovot, upon whose research Proneuron was founded, told BioWorld International.

Proneuron's spinal cord cell therapy must be started within a few days of the injury and thus is not a treatment for chronically paralyzed patients who sustained injuries in the past.

There are about 12,000 spinal cord injuries per year in the U.S. alone, mostly the results of vehicular or sports accidents. Each injury causes enormous suffering to the patients and their families, and leads to lifetime health care costs averaging an estimated $750,000 per patient.

Proneuron Biotechnologies' proprietary technologies are protected by exclusive worldwide rights. The company was established in 1996 and has obtained about $7 million in funding from the U.S. Hudson Investment Group, D.S. Polaris Ltd., Lapid Medical Ventures, Nessuah-Zannex Venture Capital Management Ltd. and Infinity Venture Capital Fund L.P.

Other technologies in the Proneuron pipeline will treat CNS disorders and systemic immune-related disorders, including T-cell neuroprotection technology for the treatment of partial spinal cord injury, glaucoma, diabetic neuropathy and other disorders, and immune privilege factor, an inflammatory suppressant for the treatment of degenerative CNS diseases such as Alzheimer's, Parkinson's and multiple sclerosis.