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GB Therapeutics Ltd. Acquires License For A Phase 2 Neuropathic Pain molecule


10/19/2005 5:11:43 PM

MISSISSAUGA, ON, Aug. 10 /PRNewswire/ -- Anthony Giovinazzo, President & CEO of GB Therapeutics Ltd. (GBt), announced today that on July 29, 2004 GB Therapeutics Ltd. concluded an agreement with Chiesi Farmaceutici S.p.A. headquartered in Parma, Italy, for a worldwide exclusive license of Chiesi's CHF3381 molecule. The molecule is a dual-mechanism NMDA (N-methyl-D Aspartate) antagonist and MAO-A (monoamine oxidase-A) inhibitor and will initially be targeted at Neuropathic Pain. Phase 2 trials are expected to commence in Q2, 2005. Financial terms of the arrangement were not disclosed.

"We are delighted to have been able to obtain the license to this molecule, which is a true example of a third generation, oral, NMDA modulator and we are especially pleased to be partnering with Chiesi, which has invested a significant effort in pre-clinical and clinical development" said Mr. Giovinazzo. "As an NMDA antagonist with unique attributes, the molecule did not exhibit any of the side effects in human studies seen with other NMDA blocker molecules. This molecule has the potential for use in post-operative pain and Alzheimer's Disease", he added.

"We are very pleased to have this agreement with GB Therapeutics Ltd." said Dr. Alberto Chiesi, President & CEO of Chiesi Farmaceutici, "since GB has significant experience in the area of Central Nervous System diseases".

About CHF3381 (GT3381)

CHF3381 (to be known in the future as GT3381) has been identified as having activity at the NMDA ion channel and also includes monoamine oxidase (MAO) inhibitory activity. A complete screening of the biochemical profile of GT3381 led to the identification of its mechanism of action as a use and voltage-dependent NMDA channel blocker and a reversible MAO-A inhibitor. Both activities were observed at low micromolar concentrations. The compound has shown excellent results in a variety of preclinical efficacy studies used in identifying Neuropathic Pain candidates. It has completed Phase 1a and Phase 1b human safety and tolerability studies in Europe. Further, a proof of concept study in human volunteers was completed at a specialised pain management centre in Copenhagen, Denmark.

About Neuropathic Pain

Neuropathic pain can include: diabetic neuropathies, HIV neuropathy and chemo-therapy induced neuropathy among others. The development of Neuropathic Pain is thought to arise from long-term changes in the processing of nociceptive information, particularly in the Central Nervous System (CNS). There is evidence that changes in the structure, connectivity, receptor phenotype, and activity of nociceptive neurons may all contribute to the development of abnormal pain states. Among the most important changes that have been proposed to occur, is a development of "central sensitization" of spinal nociceptive neurons in the CNS.

Among the many neurochemical mechanisms believed to be involved in the CNS processes, one of the most important mechanisms involved in the development and maintenance of chronic pain syndromes appears to be NMDA glutamate ion channel receptors in the spinal cord, which are validated primary molecular targets for pain modulation.

About GB Therapeutics Ltd.

GB Therapeutics Ltd. (GBt) is a development stage pharmaceutical company that is developing products for neurodegenerative disorders and pain which may include mechanisms related to glutamate processing in the nervous system. These mechanisms play significant roles in neuroprotection and neuronal functional efficiency, and therefore play an important role in neurodegenerative disorders, cognitive deficiencies, and chronic pain.

GBt is supported by venture capital with VenGrowth Capital Partners Inc. as its primary investor. The Company is development based, focusing on building a portfolio of proprietary and in-licensed drug candidates for diseases of the central nervous system. The Company's core competency is to identify innovative, cost-effective drugs that provide more effective relief with fewer side effects, and, in the case of neurodegenerative diseases like Alzheimer's Disease, Parkinson's Disease, and ALS (Lou Gehrig's Disease), can slow the progression of these diseases.

About Chiesi Farmaceutici S.p.A.

Chiesi Farmaceutici is one of the largest Italian-owned European pharmaceutical groups headquartered in Parma, Italy. The company is dedicated to the research, development and commercialization of ethical products, focusing on respiratory, cardiovascular, musculoskeletal / inflammation and neonatology therapeutic areas. Consolidated group turnover was EUR 474 mil in 2003. Chiesi has marketing and sales organizations in all the major European markets and product distribution in over 40 countries. Chiesi employs 2600 people worldwide, including approximately 300 scientists in research facilities in Italy, France and the US.

GB Therapeutics Ltd.

CONTACT: Anthony Giovinazzo, President & CEO, GB Therapeutics Ltd., 2480Dunwin Drive, Mississauga, Ontario, L5L 1J9, CANADA, Tel: (905) 607-4903 ext222, Fax: (905) 607-7351, Email: agiovinazzo@gbtherapeutics.com



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