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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

Selected Therapy Can Advance to Phase III Clinical Trial

PALO ALTO, Calif., Dec. 3 /PRNewswire-FirstCall/ -- Avicena Group, Inc. (OTC Bulletin Board: AVGO), a late-stage biotechnology company that develops central nervous system therapeutics for neurodegenerative diseases, today 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 ALS Association, 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 dif
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SOURCE Avicena Group, Inc.
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