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USPTO Issues Patent for Avicena Groupís Proprietary Compounds to Treat Amyotrophic Lateral Sclerosis
Tuesday, November 13, 2007
Patent Expands Existing IP to Treat ALS
Palo Alto, CA -- Avicena Group, Inc. , a late-stage biotechnology company that develops central nervous system therapeutics for neurodegenerative disorders, announced today that the United States Patent and Trademark Office (USPTO) has granted the Company U.S. Patent #7,285,573 for the use of the Company's proprietary drug candidates for the treatment of amyotrophic lateral sclerosis ("ALS" or "Lou Gehrig's Disease"). This patent expands the Company's existing U.S. and international IP portfolio to 22 issued patents and 30 pending patents.
This patent provides further protection for the Company's growing portfolio of drug candidates for the treatment of ALS, which are designed to slow disease progression and improve the quality of life for patients. The Company's present ALS drug candidates, AL-02 and AL-08, have been the subjects of an extensive body of clinical research including Phase II/III trials conducted by the Northeast ALS Consortium (NEALS), Carolinas Medical Center and Utrecht University. The pooled analysis of these studies showed an increase of 1.47-fold in median survival compared to results in patients taking a placebo. Portions of these data have been presented to the FDA and formed the basis for Avicena Group's intent to initiate a confirmatory Phase III trial in 2008. This study will evaluate AL-02's effect on the primary endpoint of median survival and secondary endpoints of ALS functional scores.
"Avicena continues to execute its critical milestones. While we are advancing our drug candidates through clinical trials, including the ongoing Phase III trial in Parkinson's disease, we are also securing patent protection as we move closer to potential commercialization of our therapeutic candidates," stated Belinda Tsao Nivaggioli, Ph.D., Chairman and CEO of Avicena. "We are very excited about the prospects of AL-02 for the treatment of ALS and are gearing up to initiate the confirmatory Phase III early 2008."
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-sponsored Phase III trial in Parkinson's disease. Avicena Group's science is well established and its products are safe and well tolerated. Unlike traditional biotechnology companies, Avicena Group'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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