Allon completes dosing in Phase II cognitive impairment trial

27-May-2008

Allon Therapeutics Inc. announced it has completed the randomized portion of its 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. The Company expects to release top-line results from this trial in the third quarter.

Gordon McCauley, President and CEO of Allon, said the trial will determine whether a single dose of AL-208 administered to patients prior to CABG surgery has an impact on their cognitive performance two to three weeks after their surgery.

"It is well established that a majority of patients who have CABG surgery emerge with mild cognitive impairment (MCI) likely resulting from short-term ischemia, or reduced blood supply, in the brain," said McCauley. "A reduction in cognitive impairment in these patients would confirm the efficacy we have already shown in numerous animal studies of acute brain injury. This outcome would establish the potential of AL-208 to reduce or prevent the damage that results from CABG surgery and in other medical conditions, including ischemic stroke and traumatic brain injuries."

The Phase II clinical trial was conducted at 28 medical centres in the United States and Canada. The study was a randomized, placebo-controlled, double-blind, parallel-group evaluation of the safety, tolerability and effect of a single 300 mg intravenous infusion of AL-208 administered 30 minutes prior to CABG surgery. Approximately half of the 210 patients randomized were treated with AL-208 and half were given a placebo.

The primary objective of the randomized study is to demonstrate an impact on cognitive performance in patients treated with AL-208 compared with patients given placebo when measured 2-3 weeks post surgery. Cognitive performance was assessed by a regimen of neuropsychological tests evaluating memory and executive function. The study will also expand the safety database on this drug.

In several preclinical studies, AL-208 has demonstrated statistically significant protection in animal models of stroke, traumatic brain injury, and in models of acute eye injury.

https://www.bionity.com/en/news/82570/allon-completes-dosing-in-phase-ii-cognitive-impairment-trial.html