Avicena To Proceed To Confirmatory Phase III Amyotrophic Lateral Sclerosis (ALS) Trial

Main Category: Muscular Dystrophy / ALS
Also Included In: Clinical Trials / Drug Trials;  Neurology / Neuroscience
Article Date: 18 Jul 2007 - 0:00 PDT

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Avicena Group, Inc. (OTC Bulletin Board: AVGO), a late stage biotechnology company that develops central nervous system therapeutics for neurodegenerative diseases, announced today that it met with the Food and Drug Administration (FDA) and will proceed with a confirmatory Phase III trial of its lead drug candidate, AL-02, for the treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease).

Two completed Phase III studies led by Dr. Jeffrey Rosenfeld of the Carolinas ALS Center and North East ALS Consortium (NEALS) demonstrated a positive trend towards increased survival at 9 months. The results of the studies are pending publication. Further, Avicena will be analyzing the data at the 18-month time point to confirm a longer term survival benefit. These data will be used to support a new Phase III study which is planned to commence in 2008. The new Phase III study will be designed to evaluate AL-02's potential to increase survival.

"We are very pleased with the FDA's feedback and we eagerly anticipate moving AL-02 forward into a confirmatory Phase III trial during the first quarter of next year," stated Belinda Tsao-Nivaggioli, Chief Executive Officer of Avicena. "Given the severity of this unmet medical need, the advancement of our lead ALS drug candidate represents significant progress for Avicena and our collaborators, NEALS and the Carolinas ALS Center. We hope to duplicate the pooled results of two prior studies which demonstrated AL-02's potential to increase survival of patients afflicted with ALS."

ABOUT ALS

ALS is a neurodegenerative disease that attacks the motor neurons of the brain and spinal cord that are responsible for voluntary muscle movement. As these motor neurons degenerate, their ability to send impulses to the muscle fibers is compromised. The progressive degeneration of motor neurons eventually leads to neuron death resulting in the brain's inability to initiate or control muscle movement. Once a patient's muscles no longer receive the messages that they require to function, the muscles begin to atrophy. With an incidence rate of approximately 1 in 10,000, ALS affects roughly 30,000 Americans at any given time. Each year, approximately 5,600 new cases of ALS are diagnosed.

ABOUT AVICENA

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). The company is currently analyzing data from its Phase IIb/III trial in ALS. Near term, Avicena intends to initiate a Phase III trial in Huntington's disease to accompany the ongoing 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.

SAFE HARBOR

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.

Avicena Group, Inc.
http://www.avicenagroup.com

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