Published: July 17, 2007 at 2:27 PM

Avicena plans confirmatory ALS trial

PALO ALTO, Calif., July 17 (UPI) -- U.S. firm Avicena said Tuesday it would launch a confirmatory phase 3 trial of AL-02 to treat amyotrophic lateral sclerosis, or Lou Gehrig's disease.
The company said a pair of phase 3 studies already completed suggested the new treatment improves survival in ALS patients at nine months, with data at 18 months yet to be evaluated.
The confirmatory phase 3 trial is set to begin in the first quarter of 2008, Avicena said.

"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," said Belinda Tsao-Nivaggioli, Avicena's chief executive officer.

ALS is a neurodegenerative disorder marked by the breakdown of the motor neurons in the brain and spinal cord that control voluntary muscle movement, which interferes with the neurons' ability to send impulses to the muscles. About 30,000 Americans have ALS, with roughly 5,600 new cases diagnosed each year, the company said.

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.

     Contact:

     The Ruth Group (on behalf of Avicena Group, Inc.)

     Sara Ephraim (investors)
     (646) 536-7002
     sephraim@theruthgroup.com

     Janine McCargo (media)
     (646) 536-7033
     jmccargo@theruthgroup.com

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