Allon Therapeutics Inc.
TSX : NPC

Allon Therapeutics Inc.

August 12, 2008 09:15 ET

Pharmacokinetics Study Confirms Therapeutic-Enabling Quantities of Allon's Drugs AL-108 and AL-208 in Human Cerebrospinal Fluid

VANCOUVER, BRITISH COLUMBIA and BOSTON, MASSACHUSETTS--(Marketwire - Aug. 12, 2008) - Allon Therapeutics Inc. (TSX:NPC) announced today that a pharmacokinetics study has confirmed that the Company's clinical stage drugs AL-108 and AL-208 penetrate the blood brain barrier of healthy adults and Alzheimer's disease patients in sufficient quantities to enable a therapeutic effect on Alzheimer's and other neurodegenerative diseases.

Gordon McCauley, President and CEO of Allon, said the results support the Company's ongoing clinical development programs for AL-108 and AL-208 and will help determine appropriate dosages for future clinical trials.

"Our results confirmed that therapeutic-enabling quantities of AL-108 or AL-208 were found in the cerebrospinal fluid (CSF) of the healthy adults and the Alzheimer's patients," said McCauley. "The amounts of AL-108 and Al-208 in the CSF were dose proportional and both drugs were safe and well-tolerated by the test subjects."

McCauley announced the pharmacokinetic results during his presentation to the Canaccord Adams Inc. 28th Annual Global Growth Conference in Boston, MA. The conference brings together institutional investors, venture capital investors and small to mid-cap growth-oriented companies.

Allon is developing AL-108 as a treatment for Alzheimer's disease and for schizophrenia-related cognitive impairment. Allon is developing AL-208 as a treatment for the ischemic damage resulting from a variety of acute brain injuries.

- Earlier this year, Allon announced that a Phase IIa clinical trial evaluating AL-108 in 144 patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer's disease, demonstrated that specific memory function improved in patients who were given twice daily dosages of 15 milligrams (mgs) of AL-108 intranasally over 12 weeks. Later this year, the Company will begin enrolment in a Phase IIb clinical trial evaluating AL-108 in Alzheimer's patients.

- The Company expects to complete patient enrolment during the Third Quarter and report top-line results during the Fourth Quarter from a Phase II clinical trial evaluating AL-108 as a treatment for schizophrenia-related cognitive impairment.

- The Company expects to release top-line results during the Third Quarter from the randomized portion of a Phase II clinical trial evaluating the safety, tolerability and effect of AL-208 as a prevention for the mild cognitive impairment resulting from ischemic damage during coronary artery bypass graft surgery.

Pharmacokinetic study results

Test subjects were given a single 15 mg intranasal dose of AL-108 or a single intravenous dose of 50 mg or 300 mg of AL-208. These doses were found to be safe and well-tolerated by the healthy volunteers and mild-to-moderate AD patients.

The pharmacokinetic profile of AL-108 and AL-208 in healthy volunteers confirm results obtained in Allon's previous Phase 1 trials. These conclusions are based on measures of peak concentrations, overall exposure to drug and rate of clearance. The concentration of AL-108 and AL-208 in CSF indicate that the drug crosses the blood-brain barrier in quantities that have conferred protection in prior experimental models.

McCauley said the pharmacokinetic profile of 15 mg AL-108 in mild-to-moderate Alzheimer's patients provides sufficient information to design dose-range components of the Company's proposed Phase IIb Alzheimer's trial. "The modest intra-individual variability observed in the Alzheimer's patients validates the intranasal route of administration for this therapeutic indication and provides us with added confidence in moving this program forward," said McCauley.

About Allon's neuroprotective platforms

Allon's two neuroprotective technology platforms are based on two naturally occurring proteins secreted by the brain in response to a range of insults. The platforms are activity-dependent neuroprotective protein (ADNP) and activity-dependent neurotrophic factor (ADNF). Because the two platforms are based on different proteins, the drugs from each are different molecules with different therapeutic mechanisms and distinct commercial opportunities. Clinical-stage drugs AL-108 and AL-208 are derived from ADNP, while preclinical stage drug AL-309 is derived from ADNF.

About Allon

Allon Therapeutics Inc. is a clinical-stage biotechnology company developing treatments for major neurodegenerative conditions. In Q1 2008, Allon's drug AL-108 demonstrated human efficacy in amnestic mild cognitive impairment, a precursor to Alzheimer's disease. Allon has Phase II human efficacy programs pursuing three large underserved markets: Alzheimer's disease, stroke and schizophrenia-related cognitive impairment. The Company is listed on the Toronto Stock Exchange under the trading symbol "NPC" (Neuro Protection Company™) and based in Vancouver. For additional information please visit the Company's website: www.allontherapeutics.com.

Forward Looking Statements

Statements contained herein, other than those which are strictly statements of historical fact may include forward-looking information. Such statements will typically contain words such as "believes", "may", "plans", "will", "estimate", "continue", "anticipates", "intends", "expects", and similar expressions. While forward-looking statements represent management's outlook based on assumptions that management believes are reasonable, forward-looking statements by their nature are subject to 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 them. Such factors include, among others, the inherent uncertainty involved in scientific research and drug development, Allon's early stage of development, lack of product revenues, its additional capital requirements, the risks associated with successful completion of clinical trials and the long lead-times and high costs associated with obtaining regulatory approval to market any product which Allon may eventually develop. Other risk factors include the limited protections afforded by intellectual property rights, rapid technology and product obsolescence in a highly competitive environment and Allon's dependence on collaborative partners and contract research organizations. These factors can be reviewed in Allon's public filings at www.SEDAR.com and should be considered carefully. Readers are cautioned not to place undue reliance on such forward-looking statements and Allon disclaims any obligation to update or announce changes in any such factors except in its periodic filings.

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