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  Proneuron announces patent for Copolymer-1
Posted February 16, 2005 in ALS News

BusinessWire

Proneuron Biotechnologies, announced today the granting of U.S. Patent No. 6,844,314 for the use of Copolymer-1 (Cop -1) for protection from neuronal degeneration. The patent was granted to Proneuron Scientific Founder Professor Michal Schwartz of the Weizmann Institute of Science. The patent, exclusively licensed to Proneuron, is owned by Yeda Research and Development Company Ltd., the commercial arm of the Weizmann Institute of Science.

Cop-1 was invented at the Weizmann Institute of Science over thirty years ago and licensed to Teva Pharmaceutical Industries (Nasdaq: 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. Years of research, led by Prof. Michal Schwartz of the Weizmann Institute of Science, has shown that Cop-1 acts as a low-affinity antigen that activates a wide range of self-reacting T cells, resulting in neuroprotective autoimmunity that is safe and effective against both CNS white matter and grey matter degeneration. The neuroprotective effect of Cop-1 vaccination was demonstrated in preclinical models of acute and chronic neurological injuries and disorders such as optic nerve injury, head trauma, glaucoma, Amyotrophic Lateral Sclerosis and Huntington's disease.

Under a collaboration agreement with Teva from 2001 and its 2003 expansion, Cop-1 is being developed by Teva as a therapy for several neurodegenerative conditions. Under this collaboration, a joint project is in progress to use Cop-1 for Huntington's disease, ALS and for the attenuation of the progressive optic nerve and retinal degeneration that causes visual field loss and eventually blindness in glaucoma patients. Cop-1 is expected to enter Phase II clinical trials in the near future for a number of indications. The collaboration provides for milestone payments to Proneuron of up to $190 million and includes royalties on worldwide sales. To date, total payments received from Teva pursuant to this collaboration, exceed $20 million.

The patent granted is the latest in a series of patents granted to Yeda and licensed to Proneuron including that for ProCord (autologous incubated macrophage therapy), PN277 and others.

"The evidence for the dual action of Cop-1, as an anti-inflammatory and a neuroprotective drug, has been fundamentally strengthened thanks to the research led by Proneuron and the Weizmann Institute of Science. Our collaboration with Proneuron presents us with a great opportunity to expand the use of this important drug," said Teva's V.P. of Strategic Business Planning and New Ventures, Dr. Aharon Schwartz.

"We are very pleased by the issuance of this patent that further supports Proneuron's drug development efforts. It is a green light for the company and Teva to further enhance the development of Cop-1 for an expanded list of indications in addition to the original use for Multiple Sclerosis," said Proneuron's CEO Mr. Nir Nimrodi.

Proneuron Biotechnologies Inc. is a privately held biopharmaceutical company developing products for the medical treatment of spinal cord injuries and other disorders of the central nervous system. Its products are based on proprietary technology for modulating the interaction between the nervous and immune systems. The company's products are currently being evaluated in several clinical studies located in the U.S., Belgium and Israel. These include: an independently managed, international, multi-center, randomized-controlled Phase II trial of ProCord, autologous incubated macrophages, an experimental procedure for spinal cord injuries and a Phase II program of Cop-1 for the treatment of Huntington's disease (HD), Glaucoma and other neurodegenerative diseases. The latter is being managed by Teva as part of the Proneuron's strategic collaboration for development and commercialization of Cop-1 for various neurodegenerative indications. The Company is also developing PN277 for the treatment of additional neurodegenerative diseases.

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