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Avicena Advances Clinical Development Of HD-02 For Huntingto

时间:2006-12-13 22:26来源:medicalnewstoday.com 作者:admin 阅读:


Avicena Group, Inc. (OTC Bulletin Board: AVGO), a biotechnology company focused on commercializing its proprietary cellular energy modulation technology, announced today the initiation of a chronic toxicology study of HD-02, its lead candidate for Huntington's disease (HD).

The study marks the latest advancement in the progression of Avicena's HD program and is expected to conclude during the second half of 2007. Upon successful completion of this animal toxicity study, Avicena intends to initiate a Phase III clinical trial.

This study is the next step in the steady development program for HD-02, which has been granted orphan drug designation by the FDA. Results from a previous Phase I/II clinical study of HD-02, published in the January 24, 2006, issue of Neurology, demonstrated that the drug was safe and well- tolerated at a dose of 8 g/day in HD patients. HD-02 patients also showed reduced levels of an oxidative marker, serum 8-hydroxy-2'-deoxyguanosine, which some researchers have linked to reduced oxidative injury in patients with Huntington's disease. Earlier preclinical trials examining the effects of HD-02 in a model of Huntington's disease showed significantly improved survival and slowed the rate of brain atrophy.

"We are continuing to move our HD program forward, and I am very encouraged by the Phase I/II results as well as by our previous clinical and pre-clinical data," stated Belinda Tsao-Nivaggioli, Avicena's chief executive officer. "To date, HD-02 has shown significant potential in Huntington's disease, and based on the results of this toxicology study, we expect to initiate a Phase III trial for HD-02 in 2007."

ABOUT HUNTINGTON'S DISEASE

Huntington's disease is a progressive neurodegenerative disease that is caused by a defective gene. This genetic defect, which is often inherited, causes the deterioration of neurons in those parts of the brain that are responsible for controlling cognitive, emotional and motor functions. As a result, patients suffer a variety of symptoms including uncontrollable muscle movements, clumsiness, memory loss, and, ultimately, severe mental deterioration. In the United States, approximately 35,000 people suffer from Huntington's disease. There is presently no known cure for Huntington's disease.

ABOUT AVICENA

Avicena Group, Inc. (OTCBB: AVGO) 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 both a Phase III trial in Huntington's disease and a 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 early state 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/
(责任编辑:泉水)
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