Allon Therapeutics Inc.

Allon Therapeutics Inc.

December 18, 2007 08:30 ET

Allon Therapeutics Completes Dosing in Phase II Clinical Trial in Alzheimer's Program

VANCOUVER, BRITISH COLUMBIA--(Marketwire - Dec. 18, 2007) - Allon Therapeutics Inc. (TSX:NPC), The Neuro Protection Company™, announced today that it has completed patient dosing for its Phase II clinical trial evaluating the safety and efficacy of the Company's proprietary drug candidate AL-108 in patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer's disease (AD).

Allon said the trial will continue gathering data into the first quarter as patients undergo a final follow-up assessment. The Company is on schedule to release results from the trial during the first quarter of 2008.

Gordon McCauley, Allon's President and CEO, said the objective of the trial is to evaluate AL-108's potential to treat the causes and halt the progression of AD.

"This trial is designed to demonstrate that AL-108 has an impact on memory function. AL-108 would be the first drug under development to improve memory performance by impacting the mechanisms that lead to physical damage in the brain caused by neurofibrillary tangles, one of the two established pathological hallmarks that are common to aMCI and AD," McCauley said.

"We were the first company to achieve this in preclinical animal studies and now we expect to demonstrate the same capability in people." Allon's program is also the first clinical program to show an effect in animals on both of the classic hallmarks of Alzheimer's: Neurofibrillary tangles and amyloid beta plaques.

McCauley said the Phase II trial of AL-108 in aMCI will provide key information for progression into a larger but more focused Phase II trial in AD.

Dr. Donald E. Schmechel, the principal investigator of the trial, said that all the drugs now approved for the treatment of AD offer some symptomatic relief, but have no impact on the disease process itself or the progression of the disease.

"If Allon's Phase II trial can achieve in people what it achieved in animals, AL-108 will have demonstrated significant potential to become the first drug to treat the causes and halt the progression of Alzheimer's disease," Schmechel said. Dr. Schmechel is an adjunct Professor of Medicine (Geriatics), at Duke University Medical Center in Durham, North Carolina and the Medical Director of The Falls Neurological and Memory Center at the Caldwell Memorial Hospital.

Trial design and objectives

The Phase II trial is a double-blind, randomized, placebo-controlled, multiple-dose study to evaluate the safety, tolerability and effect on cognitive function of AL-108 after 12 weeks of intranasal administration in patients with aMCI.

The trial is being conducted at 15 sites in the United States in patients aged 55 to 85 years diagnosed with aMCI. The trial was designed to achieve statistical significance with 120 patients, but enrolled over 140. Three groups of patients received either placebo, low dose of AL-108 (5 mg once a day) or high dose (15 mg twice a day) intranasally for 12 weeks. Completion of patient enrolment was announced October 2, 2007.

The objective of the primary endpoint of the trial is to demonstrate an overall improvement on memory performance after 12 weeks of treatment with AL-108. This overall memory performance will be determined from a composite score of different tests that together measure short-term memory, recognition, working memory, strategic use of memory, episodic memory and associative learning.

The secondary endpoints represent signals of efficacy that correlate to the specific cognitive changes impacted by AL-108 treatment. These secondary endpoint objectives will demonstrate an impact of AL-108 on a number of individual cognitive performance tests over the 16 weeks of the trial, including improvements in memory, learning, problem solving and motor control. These individual measures are in addition to further analysis of overall memory performance in the composite score both during and after the treatment period.

Additional Efficacy Trials

Allon has two additional Phase II human efficacy trials under way pursuing three large underserved markets: schizophrenia and cognitive impairment. The Phase II study in mild cognitive impairment post-coronary artery bypass graft (MCI-CABG) is evaluating the potential for AL-208 to be used as a treatment for the ischemic damage that results from heart bypass surgery as well as other indications such as stroke. The Phase II study in schizophrenia cognitive impairment is evaluating the potential of AL-108 to be used as a treatment for the debilitating cognitive impairment suffered by most schizophrenia patients. Each of these studies has the potential to lead to a significant treatment opportunity and is evaluating Allon's drugs in different patients, medical conditions and clinical endpoints using two different routes of administration.

About Allon

Allon Therapeutics Inc. is a clinical-stage biotechnology company developing treatments for major neurodegenerative conditions. Allon has 3 Phase II human efficacy trials underway pursuing three large underserved markets: Alzheimer's disease, schizophrenia and cognitive impairment. The Company is listed on the Toronto Stock Exchange under the trading symbol "NPC" (Neuroprotection Company™) and based in Vancouver. For additional information please visit the company's website:

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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