Avicena Files Composition Of Matter Patent Application For Treatment Of Huntington's Disease

Main Category: Huntingtons Disease
Also Included In: Neurology / Neuroscience;  Clinical Trials / Drug Trials
Article Date: 01 May 2007 - 0:00 PDT

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Avicena Group, Inc. (OTC Bulletin Board: AVGOE), a late stage biotechnology company focused on commercializing its proprietary cellular energy modulation technology, announced today that it has filed a composition of matter patent application with the United States Patent and Trademark Office (USPTO) to cover potential treatments for Huntington's disease, a fatal neurodegenerative disease.

This composition of matter patent aims to extend Avicena's intellectual property portfolio for its current and future drug candidates for the treatment of Huntington's disease by broadly covering pharmaceutical formulations based on creatine derivatives alone or in combination with an anti-inflammatory compound. In addition, the Company believes that this patent will extend the IP protection for its Huntington's lead drug candidate, HD-02, as well as next generation therapeutic formulations for Huntington's disease beyond Avicena's existing IP claims in neurology (US Patents 6,196,115 B1 and 6,706,764 B2). HD-02 is currently in late stage clinical trials and has U.S. orphan drug designation.

"This patent application is part of our objective to assemble a robust IP portfolio, especially as HD-02 approaches late stage development", stated Belinda Tsao-Nivaggioli, Ph.D., CEO of Avicena. "HD-02 has already demonstrated significant potential in the clinic, and was shown to reduce the Huntington's disease marker and slow the rate of disease progression in a previously completed Phase II study. As previously announced earlier this week, the publication R&D Directions highlighted HD-02 in its list of 'Top 100 Investigational Drugs of 2007.'"

ABOUT HD-02

HD-02 is novel drug candidate for the treatment of Huntington's disease (HD) with orphan drug designation in the U.S. Avicena has recently completed a Phase II clinical study of HD-02 led by Dr. Steven Hersch of Massachusetts General Hospital. Results from this study, which were published in the journal Neurology, showed that HD-02 reduced the Huntington's disease marker, which some researchers have linked to reduced brain injury. Further, HD-02 was shown to slow the rate of disease progression.

In preclinical studies performed by Dr. Flint Beal of Cornell Medical Center, HD-02 has shown significant neuroprotective effects such as improved motor movement and increased survival rate.

ABOUT HUNTINGTON'S DISEASE

HD is a progressive neurodegenerative disease caused by a defective gene that is often inherited from parent to child. This genetic defect causes a programmed deterioration of neurons in those parts of the brain that are responsible for controlling cognitive, emotional and motor functions. This progressive deterioration results in a variety of symptoms including uncontrolled muscle movement, loss of intellectual capacity, and severe emotional disturbances.

Approximately 35,000 people in the US suffer from Huntington's disease. It is estimated that an additional 250,000 Americans carry the Huntington's gene and will develop this deadly disease sometime during their lifetime.

ABOUT AVICENA

Avicena Group, Inc. is a late stage biotechnology company focused on developing products based on its proprietary understanding of the regulation of cellular energy processes. 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 (Amyotrophic Lateral Sclerosis, or Lou Gehrig's disease). Near term, Avicena intends to initiate a Phase III trial in Huntington's disease to accompany its on-going 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 ingredients to skin care manufacturers.

SAFE HARBOR

This release may contain forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements reflect, among other things, management's current expectations, plans and strategies, and anticipated financial results, 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, 2005, 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