Allon Therapeutics Inc.

Allon Therapeutics Inc.

June 02, 2006 08:30 ET

Allon Begins Enrolment for AL-208 Phase II Clinical Trial

VANCOUVER, BRITISH COLUMBIA--(CCNMatthews - June 2, 2006) - Allon Therapeutics Inc. (TSX:NPC), The Neuro Protection Company™, today announced that patient enrolment has begun for a Phase II human clinical trial evaluating the Company's product AL-208 as a treatment for the mild cognitive impairment (MCI) that commonly occurs following coronary artery bypass graft (CABG) surgery.

Gordon McCauley, President and CEO of Allon, said the Phase II trial will evaluate the safety and effectiveness of AL-208 at preventing or reducing MCI in CABG surgery patients aged 65 to 79. Preventing or reducing MCI post-CABG has a potential market estimated at US$500-million for which there is no available treatment today.

"This clinical trial is particularly significant for Allon because it is the first trial that will evaluate the effectiveness of one of our drugs in patients," McCauley said. "We believe this will be the first of several human clinical trials starting in the next year to evaluate the effectiveness of our drugs in different neurodegenerative diseases and conditions."

The initial portion of the study in which all patients receive AL-208 will be open-label to confirm safety, followed by a randomized placebo-controlled portion. In total, approximately 200 patients will be treated with AL-208 (or placebo) during surgery. The patients will be assessed using standard cognitive tests, administered several weeks after surgery, to determine the impact on cognitive function of patients treated with AL-208 versus patients in the control group. The trial will be conducted in approximately 20 hospitals in the US and Canada.

The Company expects results of the Phase II trial will be released during the second half of 2007.

Allon's compounds have been shown to be effective in preventing and repairing brain cells from disease or injury in 14 different pre-clinical animal models of eight central nervous system conditions. In some acute animal models, a single administration of AL-208 has provided 30 days of neuroprotection and maintenance of cognitive function after a single administration.

About MCI-post CABG

Mild cognitive impairment is a common result after coronary artery bypass graft surgery (CABG - commonly known as "bypass surgery").

Some studies estimate that cognitive impairment occurs in 90% of cases in the first week post-surgery, that more than 50% of patients show impairment when discharged from the hospital, and that 24% continue to show impairment after six months.

Approximately 500,000 patients in the United States and 800,000 patients worldwide undergo coronary artery bypass graft surgery every year. Currently there is no therapy available that ameliorates or treats the cognitive damage associated with artery bypass surgery.

About Allon

Allon Therapeutics Inc. is a Canadian biotechnology company developing drugs that protect against neurodegenerative conditions such as Alzheimer's disease, mild 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 Company) 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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