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Allon Therapeutics completes dosing in AL-208 phase I trial
By E. Janene Geiss
Philadelphia, Oct. 27 - Allon Therapeutics Inc., The Neuro Protection Company, said Thursday that 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 associated with cardiac artery bypass graft surgery.
In the trial, 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 the first quarter of 2006, Gordon McCauley, president and chief executive officer, said in a company news release.
"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," McCauley said.
In addition to commencing the phase IIa clinical trial in 2006, 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, McCauley said.
About 500,000 patients in the United States and 800,000 patients worldwide undergo cardiac artery bypass graft surgery every year. The post-bypass, mild cognitive impairment market is estimated at $3 billion annually.
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.
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