Avicena Announces Positive Data For Amyotrophic Lateral Sclerosis Trial

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Amyotrophic Lateral Sclerosis Trial

Avicena Group announced positive Phase II data for a combination trial involving AL-08, the Company's second generation proprietary drug candidate for the treatment of ALS. The purpose of the trial was to determine which of two compounds used in combination with AL-08 would yield the most favorable results, so that the Company could proceed to a Phase III trial. Results were presented by Paul H. Gordon, MD of Columbia University in a presentation titled "Combination Drug Selection Trial in Amyotrophic Lateral Sclerosis" at the 18th International Symposium on ALS/MND in Toronto, Canada on December 3, 2007. This study was funded by the ALSAssociation, Ride for Life, and the Russ Bowen and Spina Family Foundations.

The Phase II trial evaluated the neuroprotective capacity of two combinations, AL-08 and minocycline versus AL-08 with celecoxib, using group sequential design and a natural history control group for a futility analysis. The primary objective of the trial was selection of a treatment based on which drug combination appeared to slow deterioration in the ALS-Functional Score. Results showed that patients taking the AL-08/celecoxib combination showed a smaller mean decline in ALS- Functional Score compared to those taking the AL- 08/minocycline combination. Results also showed that the AL-08/celecoxib combination was non-futile compared to historical controls, and merits further evaluation. The trial was concluded ahead of schedule after the first pool of patients met the selection criteria.

"We are encouraged that the AL-08/celecoxib combination showed less of a decline in ALS-Functional Score compared to AL-08 and minocycline and historical control. Since the difference 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."

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"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 mean decline in ALS-Functional Score was 5.27 in the celecoxib/creatine arm, compared to 6.47 in the minocycline/creatine arm, and 5.82 in the historical control group.

The trial's secondary objective was evaluation of futility, which showed that AL-08/celecoxib was non-futile compared to historical controls and the null hypothesis of at least a 25% reduction in the ALS-Functional Score could not be rejected. This combination was selected for a Phase III study.

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