Canadian patient recruitment begins for Allon's AL-208 Phase II clinical trial
September 6, 2006
Canadian patient recruitment begins for Allon’s AL-208 Phase II clinical trial
VANCOUVER - Allon Therapeutics Inc. (TSX:NPC), The Neuro Protection CompanyTM, today announced that Health Canada has completed review of the Company’s Clinical Trial Application for the AL-208 Phase II study. Health Canada will allow the Company to begin recruiting Canadian patients into an ongoing Phase II human clinical trial evaluating its product AL-208 as a treatment for the mild cognitive impairment (MCI) that commonly occurs following coronary artery bypass graft (CABG) surgery.
The Phase II trial is currently evaluating the safety and effectiveness of AL-208 at preventing or reducing MCI on CABG surgery patients at several clinical sites in the United States. Preventing or reducing MCI post-CABG has a potential market estimated at US$500-million for which there is no available treatment today.
During the first stage of the Phase II trial, the safety of AL-208 will be confirmed in CABG patients at increasing doses. The second stage will be a placebo-controlled, double-blind, parallel-group evaluation to determine the efficacy of AL-208 at up to 25 medical centres in the United States and Canada. During the second stage, AL-208 or a placebo will be administered to patients prior to their CABG surgery. Several weeks after the surgery, the patients will undergo a battery of cognitive tests to determine whether AL-208 has prevented or reduced the cognitive impairment associated with CABG. In total, approximately 200 patients will be treated with AL-208 (or placebo) during surgery.
About Allon
Allon Therapeutics Inc. is a clinical-stage Canadian biotechnology company developing drugs that protect against neurodegenerative conditions such as Alzheimer's, cognitive impairment, stroke, traumatic brain injury, multiple sclerosis and neuropathy. The Company is listed on the Toronto Stock Exchange under the trading symbol "NPC" (Neuro Protection CompanyTM) and based in Vancouver.
Forward Looking Statements
There are forward-looking statements contained herein that are not based on historical fact, including without limitation statements containing the words “believes,” “may,” “plans,” “will,” “estimate,” “continue,” “anticipates,” “intends,” “expects,” and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others, Allon’s stage of development, lack of product revenues, additional capital requirements, risks associated with the completion of clinical trials and obtaining regulatory approval to market Allon’s products, the ability to protect its intellectual property and dependence on collaborative partners. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments.
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For further information:
Investor and Media contact:
Gordon C. McCauley
President & CEO
Allon Therapeutics Inc.
P: (604) 736-0634
C: (604) 218-4742
E: gmccauley@allontherapeutics.com
