Avicena's HD-02 to Proceed to NIH Sponsored Phase III Huntington's Disease Trial
March 12 2008 - 8:30AM
PR Newswire (US)
PALO ALTO, Calif., March 12 /PRNewswire-FirstCall/ -- Avicena
Group, Inc. (OTC:AVGO) (BULLETIN BOARD: AVGO) , a late stage
biotechnology company that develops central nervous system
therapeutics for neurodegenerative diseases, announced today that
it met with the Food and Drug Administration (FDA) and will proceed
with a Phase III trial of its lead drug candidate, HD-02, for the
treatment of Huntington's disease, pending final analysis of
completed animal toxicology studies. A double-blind,
placebo-controlled Phase III clinical trial which will be led by
Dr. Steven Hersch and Dr. Diana Rosas of Massachusetts General
Hospital, Dr. Bernard Ravina of University of Rochester and the
Huntington Study Group will evaluate the ability of HD-02 to slow
functional decline in Huntington's disease patients as measured by
the Total Functional Capacity (TFC) score. A Special Protocol
Assessment will be submitted which will expedite FDA review. The
trial will be sponsored by the National Center for Complementary
and Alternative Medicine (NCCAM) of the National Institutes of
Health (NIH) and the Orphan Product Division of the FDA. Enrollment
is anticipated to begin in Q3 2008. In previous studies, HD-02 has
shown potential neuroprotective properties in Huntington's disease
patients. Results from a Phase II clinical trial of HD-02, led by
Dr. Steven Hersch, were published in the January 24, 2006 issue of
Neurology and showed that HD-02 suppressed an oxidative damage
marker, 8OH2DG, which is a measure of cellular injury. Also, in a
dose escalation 2 year open-label study led by Dr. Steven Hersch
and Dr. Diana Rosas of Massachusetts General Hospital, higher doses
of HD-02 were observed to normalize 8OH2DG and stabilize clinical
and radiological hallmarks of HD. These findings demonstrate the
disease-modifying potential of HD-02 and provided the rationale for
a Phase III study to further evaluate its efficacy. "We are
extremely pleased with the outcome of the FDA meeting and look
forward to this pivotal assessment of HD-02 as a treatment for
slowing Huntington's disease for which there currently is no
approved treatment," stated Belinda Tsao Nivaggioli, CEO and
Chairman of Avicena. "We are also pleased to further strengthen our
on-going relationship with Dr. Steven Hersch, Dr. Diana Rosas, and
Dr. Bernard Ravina. We look forward to working with the NCCAM, a
Division of NIH, and the Orphan Products Division through their
sponsorship of this trial." "We are very enthusiastic about the
study results of HD-02 to date and excited to be advancing it into
a Phase III trial," stated lead investigator Dr. Steven Hersch.
"This Phase III study will evaluate whether HD-02 can slow the
progression of Huntington's disease, and pending positive results,
may provide a much needed treatment option to Huntington's
patients." ABOUT HD-02 HD-02 is a novel and proprietary 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 suppressed a
Huntington's disease marker. Some researchers have linked this
oxidative marker as a measure of cellular injury. Earlier
preclinical studies performed by Dr. Flint Beal of Cornell Medical
Center and Dr. Robert Ferrante of Boston University, showed that
HD-02 has significant neuroprotective effects, such as improved
movement, reduced neuropathology, and prolonged survival. 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
widespread 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 the symptoms of
Huntington's disease and an additional 150,000 Americans are at
risk to be 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. 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 Phase III trial in Huntington's disease as
discussed above and a confirmatory Phase III trial in ALS to
accompany the ongoing NIH 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, Inc.) Sara Ephraim (investors) (646)
536-7002 Janine McCargo (media) (646) 536-7033 DATASOURCE: Avicena
Group, Inc. CONTACT: investors, Sara Ephraim, +1-646-536-7002, ,
or, media, Janine McCargo, +1-646-536-7033, , both of The Ruth
Group, for Avicena Group, Inc. Web site:
http://www.avicenagroup.com/
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