FDA approves phase I clinical trial for ProNeuron's spinal cord cell therapy.
September 28, 1999

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Proneuron Biotechnologies, Inc. (Delaware) announced that the U.S. Food and Drug Administration (FDA) has approved a Phase 1 clinical trial of the company's spinal cord cell therapy for newly-injured paraplegic patients.

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

The clinical trial has been authorized by the Israeli Ministry of Health and will be conducted at two medical centers in Israel. "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. The study will involve a total of about ten new spinal cord injury patients.

Proneuron's novel spinal cord cell therapy has shown encouraging results in animal studies reported in the July 1998 edition of Nature Medicine. The procedure will consist of taking white blood cells known as macrophages from the injured patient's own blood and processing them in a laboratory for a short period. The activated cells are then administered to the patient's spinal cord. Macrophages promote wound healing in most body tissues, but are normally unable to enter the spinal cord in large numbers. However, once activated and administered directly, they promote the healing process in spinal cord tissue as well.

Proneuron's spinal cord cell therapy must be started within a few days of the injury. For this reason, the treatment cannot be applied to chronically-paralyzed patients who sustained injuries in the past.

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

Proneuron Biotechnologies´ proprietary technologies are based on research by Prof. Michal Schwartz of the Weizmann Institute, and 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.

Proneuron is developing several other technologies for the treatment of CNS disorders and systemic immune-related disorders: One is T-Cell Neuroprotection Technology for the treatment of partial spinal cord injury, glaucoma, diabetic neuropathy and other disorders. Another technology uses Immune Privilege Factor, an inflammatory suppressant for the treatment of degenerative CNS diseases such as Alzheimer's, Parkinson's and Multiple Sclerosis.

For more information contact:
Dr. Adrian Harel
Proneuron Biotechnologies (Israel) Ltd.
POB 277, Ness-Ziona
Israel 74101

Tel: +972-8-940-9550
Fax: +972-8-940-9560
Web Site: www.proneuron.com
Email: info@proneuron.com