Data on Avicena's Drug Candidate HD-02 Presented at the 2007 World Congress on Huntington's Disease
November 19 2007 - 8:30AM
PR Newswire (US)
PALO ALTO, Calif., Nov. 19 /PRNewswire-FirstCall/ -- Avicena Group,
Inc. (OTCBB: AVGO), a late-stage biotechnology company that
develops central nervous system therapeutics for neurodegenerative
diseases, announced today that Drs. Steven Hersch and Diana Rosas
presented results regarding the Company's novel Huntington's
disease treatment candidate HD-02 at the 2007 World Congress on
Huntington's Disease in Dresden, Germany. Drs. Hersch and Rosas, of
Massachusetts General Hospital, led the open- label, dose
escalation study, which evaluated daily administration of HD-02 in
doses ranging from 10 to 40 grams. Results of the study showed that
a 30-gram dose provided the optimal levels of efficacy, safety, and
tolerability. The researchers also observed a slower cognitive
decline and a sustained reduction in brain atrophy at the 30-gram
dose level. These findings demonstrate the disease-modifying
potential of HD-02 and provided the rationale for a Phase III study
to further evaluate its efficacy at the 30-gram dose. Based on
these findings, Dr. Hersch and the Huntington Study Group have
designed a double-blind, placebo-controlled Phase III clinical
trial to evaluate the 30-gram dose and its ability to slow
functional decline. The trial will be sponsored by the National
Center for Complementary and Alternative Medicine (NCCAM) of the
National Institutes of Health (NIH). Enrollment is anticipated to
begin in the second half of 2008. "We are excited about the results
of this HD-02 study in Huntington's disease and are pleased to have
identified the optimal dose for further evaluation in next-year's
Phase III trial," stated Belinda Tsao Nivaggioli, CEO and Chairman
of Avicena. "We are also pleased to further strengthen our
relationship with the NIH via their sponsorship of this trial and
look forward to working with the NCCAM within this organization to
advance HD-02." ABOUT HD-02 HD-02 is a novel drug candidate for the
treatment of Huntington's disease (HD). HD-02 has been granted
orphan drug designation in the U.S. Results from a Phase II
clinical trial of HD-02, led by Dr. Steven Hersch of Massachusetts
General Hospital, were published in the January 24, 2006 issue of
Neurology and showed that HD-02 reduced the Huntington's disease
marker, which some researchers have linked to brain injury. Earlier
preclinical studies performed by Dr. Flint Beal of Cornell Medical
Center and Dr. Robert Ferante of Boston University, showed that
HD-02 has significant neuroprotective effects, such as improved
motor movement and increased survival rate. ABOUT HUNTINGTON'S
DISEASE Huntington's Disease 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 and an additional 150,000 Americans are carriers of the
Huntington's gene. Carriers of the Huntington's gene will develop
this deadly disease during their lifetime. ABOUT AVICENA Avicena
Group, Inc. (OTCBB: AVGO) 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) Sara Ephraim (investors) (646)
536-7002 Janine McCargo / Jason Rando (media) (646) 536-7033 / 7025
or DATASOURCE: Avicena Group, Inc. CONTACT: Investors, Sara
Ephraim, +1-646-536-7002, , Janine McCargo, +1-646-536-7033, , or
Jason Rando (media), +1-646-536-7025, , all of The Ruth Group for
Avicena Group, Inc. Web site: http://www.avicenagroup.com/
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