Avicena Advances Clinical Development Of HD-02 For Huntingtons Disease
Update:2006-12-13 From:medicalnewstoday.com Fonts:【
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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.
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among other things, management's current expectations, plans and
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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
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including the company's need for additional funds, the company's dependence
on a limited number of therapeutic compounds, the early state of the
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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/