Proneuron Biotechnologies Inc. Announces Phase II Trial of Copolymer-1 for the Treatment of Patients with Huntington's Disease; Clinical Trial to Commence in Fall 2003.

Business Editors/High-Tech Writers

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LOS ANGELES & NESS ZIONA, Israel--(BUSINESS WIRE)--Sept. 22, 2003

Proneuron Biotechnologies, Inc. (www.proneuron.com), a leader in the development of treatments for spinal cord injuries and other acute and chronic disorders of the central nervous system, announced today that it has obtained the necessary approval to begin a Phase II clinical trial of Copolymer-1 (Cop-1) for the treatment of patients with Huntington's Disease (HD). The objective of the trial will be to assess the safety, the immunological response and relevant efficacy parameters following the treatment of HD patients with Cop-1.

Named for Dr. George Huntington, who first described this hereditary disorder in 1872, HD is a genetic degenerative brain disorder that slowly diminishes the ability to walk, think, talk and reason. HD usually begins in mid-life, between the ages of 30 and 45, though it can afflict those as young as two years of age. More than a quarter of a million Americans have HD or are "at risk" of inheriting the disease from an affected parent.

Cop-1 was invented at the Weizmann Institute of Science nearly thirty years ago and licensed to Teva Pharmaceutical Industries (Teva) for the treatment of Multiple Sclerosis. Teva's drug, Copaxone(R), was approved by the FDA several years ago and has since been used safely and successfully. Decades of research, led by Prof. Michal Schwartz of the Weizmann Institute of Science, have shown that neurological disorders may be effectively treated by controlling the immune activity in the central nervous system. The neuroprotective effect of Cop-1 vaccination was demonstrated in a variety of preclinical models of acute and chronic neurological disorders such as optic nerve injury, glaucoma, Amyotrophic Lateral Sclerosis and HD. In the 1990's, following the discovery of Prof. Schwartz, Proneuron secured the license to develop and commercialize Cop-1 as a therapy for all neurodegenerative disorders. During 2001, Proneuron entered into a strategic collaboration with Teva to develop and commercialize Cop-1 for various indications. Proneuron retained its exclusive rights to independently commercialize Cop-1 for HD and other indications that fall within the Company's strategic focus.

This Phase II study will be conducted in Israel and will initially include 20 to 40 patients between the ages of 18 and 70 years old. The trial will be a randomized, open label, parallel-group, dose-ranging study.

"The potential neuroprotective activity of Cop-1 was found in Proneuron's preclinical studies to be dependent on the regimen (frequency of administration of the drug). The protocol of daily treatment, currently used for treatment of multiple sclerosis, did not provide neuroprotection, whereas, a single periodic injection of Cop-1 appeared to maintain a long-term neuroprotective effect. A Phase II clinical trial is therefore needed to find out the optimal regimen for human neurodegenerative disorders," said Proneuron V.P. Clinical Development, Dr. David Snyder.

About Proneuron Biotechnologies

Proneuron Biotechnologies, Inc. is a privately held biopharmaceutical company developing products for the treatment of spinal cord injuries and other acute and chronic disorders of the central nervous system based on a proprietary technology for modulating the interaction between the nervous and the immune systems. The company is currently engaged in several clinical studies in the U.S., Belgium and Israel. These include: a trial of ProCord for the treatment of spinal cord injuries and a trial of Cop-1 for the treatment of Huntington's Disease. Proneuron is also developing PN277 for the treatment of neurodegenerative diseases.