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GB Therapeutics Ltd. Obtains Canadian Regulator's Approval To Start Human Safety Testing For GT 1061, Targeted At Alzheimer's Disease


10/19/2005 5:09:23 PM

MISSISSAUGA, ON, Dec. 4 /PRNewswire/ -- Anthony Giovinazzo, President & CEO of GB Therapeutics Ltd. (GBt), announced today that approval was obtained December 2, 2003 from the Canadian Therapeutics Products Directorate, for GBt to proceed with GT 1061 in a Phase 1a study in healthy aged volunteers. The molecule is targeted at mild to moderate Alzheimer's Disease.

"In less than a year, we have moved this drug candidate from early validation studies to approval to start clinical testing; all without compromising the breadth or depth of studies required to submit applications to the regulatory bodies. This achievement demonstrates our commitment to rapidly advance new, more effective, treatments through the clinical study process" said Mr. Giovinazzo.

"GT 1061 is the first drug candidate from a new class of molecules, discovered by GBt's founding scientists from Queens University, Kingston, Ontario. GT 1061 shows significant promise at extending the improvement in memory as well as the potential to slow disease progression, by rescuing brain cells from significant compromise or death. This molecule has been through several different models of Alzheimer-like disease using two different approaches, namely, induction of cholinergic deficits and beta-amyloid deficits, as well as four different means of testing memory formation, storage and retrieval" said Dr. Mark de Somer, Executive Vice President of Research and Development.

About Alzheimer's Disease.

Alzheimer's Disease is named after Dr. Alois Alzheimer, a German physician, who first characterized the disease in the early 1900's. Patients experience mild forgetfulness initially and then progress to the point of not being able to perform even the most basic activities of daily living. This leads to institutionalization and death from the effects of the disease, and associated complications.

With the aging of the baby boom generation, the number of patients with Alzheimer's Disease is anticipated to grow from 5.1 million in the United States in 2010, to 15 million by 2040. Worldwide estimates are approximately 2-2.5 times the United States prevalence.

Although there are five approved drugs on the market, they have weak, limited efficacy along with significant side effects. These drugs treat the symptoms of the disease, but offer no real prospect of altering the progression of the disease.

About GB Therapeutics Ltd.

GBt is supported by venture capital with VenGrowth Capital Partners Inc. as its lead investor. The Company is development based, focusing on building a portfolio of proprietary and in-licensed drug candidates for diseases of the 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, can slow the progression of these diseases. The Company's proprietary chemistry library is made up of molecules that were designed by its founding scientists to be mimetics of Nitric Oxide, with unique targeting attributes. GT 1061 is a molecule from this library.

GB Therapeutics Ltd.

CONTACT: Anthony Giovinazzo, President and CEO, GB Therapeutics Ltd.,(905) 607-4903 ext. 222, email: agiovinazzo@gbtherapeutics.com



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