MISSISSAUGA, ON, Jan. 6 /PRNewswire/ -- Anthony Giovinazzo, President & CEO of GB Therapeutics Ltd. (GBt), announced today that the United States Food and Drug Administration has reviewed GBt's first IND which will proceed to human safety testing, in a Phase 1a trial in healthy aged volunteers. The molecule is targeted for mild to moderate Alzheimer's Disease.
"I am particularly pleased with this approval as it was completed by the FDA with significant diligence and on a timely basis. This allows us to pursue our dual Canada/US clinical strategy, the first step in our global clinical and registration objective for GT 1061" said Mr. Giovinazzo.
"Phase 1a clinical trials of GT 1061 are scheduled to begin January 14, 2004 in Canada. This approval provides GBt with the first step to undertake future clinical studies of GT 1061 for Alzheimer's in the United States" said Dr. Mark de Somer, Executive Vice President of Research and Development.
About GT 1061 and the Phase 1a Trial
GT 1061 is a compound, which specifically targets the brain and mimics certain activities of Nitric Oxide. Nitric Oxide is a naturally occurring gaseous element with multiple and significant roles in the human body. In models of cognitive compromise GT 1061 demonstrated the potential to reverse memory loss and rescue brain cells from further compromise. The Phase 1a study for safety begins on January 14, 2004. It is a single escalating dose study with a randomized, double blind and placebo controlled design. Healthy volunteers will be both male and female between 50 and 70 years of age.
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.
Currently, there are five approved drugs on the market, with limited efficacy and side effects. These drugs treat the symptoms of the disease, but offer no 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 & CEO, GB Therapeutics Ltd.,2480 Dunwin Drive, Mississauga, Ontario, L5L 1J9, CANADA, Tel: (905) 607-4903ext 222, Fax: (905) 607-7351, Email: email@example.com