Allon Therapeutics Inc.
TSX : NPC

Allon Therapeutics Inc.

October 27, 2005 08:30 ET

Allon Completes Dosing in Phase I Human Clinical Trials for AL-208 Product

VANCOUVER, BRITISH COLUMBIA--(CCNMatthews - Oct. 27, 2005) - Allon Therapeutics Inc. (TSX:NPC), The Neuro Protection Company™, announced today it has completed dosing for its Phase I human clinical trial evaluating the company's product AL-208 as a treatment for mild cognitive impairment (MCI) associated with cardiac artery bypass graft surgery (CABG).

Gordon McCauley, President and CEO of Allon, said AL-208 was administered intravenously to six dose groups totaling 48 healthy adults and two additional dose groups totaling 16 healthy elderly adults in a single-dose, double-blind, placebo controlled, randomized, sequential and ascending study to evaluate primarily the safety and pharmacokinetic results. The company expects to release data in Q1 2006.

"For this Phase I study, Allon expanded the protocol by adding two additional dose groups of healthy elderly adults so that we could proceed more quickly into a Phase IIa study for mild cognitive impairment associated with bypass surgery," said McCauley. "We expect to start a Phase IIa trial for this product early in 2006."

In addition to commencing the Phase IIa clinical trial, McCauley said Allon has elected to conduct a multiple dose Phase Ib study for AL-208 in early 2006. This multiple ascending dose study will evaluate the safety and pharmacokinetics of AL-208 in healthy elderly adults and in patients with Type I and Type II diabetes. Proceeding with this study will broaden the safety profile and ensure that Allon will be able to use the AL-208 intravenous product in indications where multiple doses are required.

About MCI from artery bypass surgery

Mild cognitive impairment is a common result of damage to brain tissue that often occurs after cardiac artery bypass graft surgery (commonly known as bypass surgery). Some studies estimate that post-surgical cognitive impairment can occur in up to 90% of the 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 (Newman et al, New England Journal of Medicine 2001). The studies also showed that after five years, 42% of patients were significantly cognitively impaired compared to their pre-surgery performance.

Approximately 500,000 patients in the United States and 800,000 patients worldwide undergo cardiac artery bypass graft surgery every year. The post-CABG MCI market is estimated to be approximately $3 billion annually. Currently there is no therapy available that improves or treats the cognitive damage caused by neurons damaged or dying under the temporary anoxic conditions caused by artery bypass surgery.

About Allon

Allon Therapeutics Inc. is a Canadian biotechnology company developing drugs that protect against neurodegenerative conditions such as stroke, traumatic brain injury, Alzheimer's disease, 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.


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