PALO ALTO, Calif., Dec. 3 /PRNewswire-FirstCall/ -- Avicena Group, Inc. , 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 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."
"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.
Avicena Group, Inc. is a Palo Alto, California based late- stage biotechnology company that develops central nervous system therapeutics for neurodegenerative diseases. The Company's core technologies, supported by a robust IP portfolio, have broad applications in both pharmaceuticals and dermaceuticals. Avicena's pharmaceutical program centers on rare neurological disorders (orphan diseases). Near term, the Company plans to initiate a confirmatory Phase III trial in ALS and a Phase III trial in Huntington's disease to accompany the ongoing NIH Phase III trial in Parkinson's disease. Avicena's science is well established and its products are safe and well tolerated. Unlike traditional biotechnology companies, Avicena's clinical programs are largely funded by government and non-profit organizations. Avicena presently derives revenue from the sale of proprietary dermaceutical ingredients to skin care manufacturers.
This release contains forward-looking statements that reflect, among other things, management's current expectations, plans and strategies, all of which are subject to known and unknown risks, uncertainties and factors that may cause our actual results to differ materially from those expressed or implied by these forward-looking statements. Many of these risks are beyond our ability to control or predict. See "Risk Factors" under "Item 6. Management's Discussion and Analysis of Financial Condition and Results of Operation" from our Annual Report on Form 10-KSB for the year ended December 31, 2006, and other descriptions in the Company's public filings with the Securities and Exchange Commission for a discussion of such risks, including the Company's need for additional funds, the Company's dependence on a limited number of therapeutic compounds, the stage of the products the Company is developing, uncertainties relating to clinical trials and regulatory reviews, competition and dependence on collaborative partners, the Company's ability to avoid infringement of the patent rights of others, and the Company's ability to obtain adequate patent protection and to enforce these rights. Because of these risks, uncertainties and assumptions, you should not place undue reliance on these forward-looking statements. Furthermore, forward-looking statements speak only as of the date they are made. Avicena does not undertake any obligation to update or review any such forward-looking information, whether as a result of new information, future events or otherwise.
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