Allon Completes Dosing in Phase II Cognitive Impairment Study
Posted on: Monday, 26 May 2008, 06:00 CDT
Allon Therapeutics 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 that commonly occurs following coronary artery bypass graft surgery.
The Phase II clinical trial was conducted at 28 medical centres in the US and Canada. The study was a randomized, placebo-controlled, double-blind, parallel-group evaluation of the safety, tolerability and effect of a single 300mg intravenous infusion of AL-208 administered 30 minutes prior to coronary artery bypass graft (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. The company expects to release top-line results from this trial in the third quarter of 2008.
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."
Source: Datamonitor
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