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Avicena Announces Positive Phase II Data for a Combination Trial Involving AL-08 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
Date:12/3/2007

ference in the ALS- Functional Score between the therapies tested was large enough, and comparison to the historical controls was non-futile at the 6-month time point, we were able to finish the trial early after just 60 patients," stated Dr. Gordon. "We originally planned to enroll up to 120 patients, in sequential pools of 60. Our ability to halt the trial early underscores the potential efficacy of AL-08, which can be further evaluated in a Phase III ALS clinical trial."

"We are pleased that AL-08/celecoxib slowed deterioration in ALS- Functional Score compared to the other treatment and believe that results of this trial highlight the potential of this combination treatment for ALS patients," stated Belinda Tsao Nivaggioli, CEO and Chairman of Avicena. "We are eager to proceed with designing our Phase III clinical trial which will attempt to confirm the efficacy of AL-08".

About the Trial

The randomized, double-blind, selection trial targeted enrollment of up to 120 patients in sequential pools of 60 to evaluate the neuroprotective capacity of two drug combinations, AL-08/ minocycline and AL-08/celecoxib. The trial used a group sequential design and a natural history control group for a futility analysis. The primary objective was treatment selection based on which drug combination appeared to slow deterioration in the ALS-Functional Score.

Patients were randomized to receive daily administration of AL- 08/minocycline or AL-08/celecoxib. The trial was stopped early after the first pool of 60 patients when the selection criteria was met by showing a large enough difference in ALS-Functional Score between the two treatment arms.

Results showed that patients treated with AL-08/celcoxib showed a smaller mean functional decline versus AL-08/minocycline. At the end of the trial, the decline in ALS-Functional Score in both treatment arms was compared separately to the mean historical control group at a 0.05 significance level. The mea
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SOURCE Avicena Group, Inc.
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