Avicena Group,
Inc. (OTC Bulletin Board: AVGO), a late stage biotechnology company that
develops central nervous system therapeutics for neurodegenerative
diseases, announced today the selection of the optimal dose of HD-02, its
novel drug candidate for the treatment of Huntington's Disease. This dose
was determined in an open-label dose escalation study, led by Dr. Steven
Hersch and Dr. Diana Rosas of Massachusetts General Hospital (MGH), and
will be further evaluated in a Phase III clinical trial.
The dose escalation study evaluated HD-02 in a range of doses from 10
to 40 grams per day and successfully determined the optimal dose that
provided the maximum efficacy, safety and tolerability. The full scope of
the data will be disseminated upon the results being peer reviewed.
Based on these findings, Avicena and its collaborators Dr. Hersch and
the Huntington Study Group have developed a double-blind,
placebo-controlled Phase III clinical trial anticipated to commence in
early 2008. The Phase III trial will be one of the single largest trials
for Huntington's patients, with external funding to be announced.
Upon commencement of this clinical trial, Avicena will have advanced
three different indications into phase III trials that include some of the
largest trial to date in both Parkinson's and Huntington's.
"We are very encouraged by the results of our HD-02 trial and we
believe that in conjunction with our collaborators at MGH, we have
identified the optimal dose as we move forward to validate HD-02 as a
potential treatment for Huntington's disease, for which there is no current
approved drug by the FDA. We are committed to developing therapeutics that
we hope can slow the progression of neurodegenerative diseases," stated
Belinda Tsao-Nivaggioli, CEO of Avicena.
"We are excited by the results of our studies with HD-02 to date. This
Phase III study will evaluate whether HD-02 can slow the progression of
Huntington's disease and translate into real-world clinical benefits for
patients," stated lead investigator Dr. Steven Hersch.
ABOUT HD-02
HD-02 is a 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 January 24, 2006 issue of Neurology, showed that HD-02
reduced the Huntington's disease marker, which some researchers have linked
to brain injury. Further studies by Dr. Hersch and Dr. Rosas have optimized
the dosing of HD-02 and provided further evidence supporting its potential
to slow HD.
Earlier preclinical studies performed by Dr. Flint Beal of Cornell
Medical Center and Dr. Robert Ferante of Boston University, HD-02 have
shown significant neuroprotective effects such as improved motor movement
and increased survival rate.
Avicena intends to collaborate with Dr. Hersch and the Huntington Study
Group to initiate a Phase III trial in early 2008 following completion of a
chronic toxicology study that is currently underway.
The magazine R&D Directions recently selected HD-02 as one of the "100
Great Investigational Drugs of 2007" in the March 2007 issue.
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
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. (OTC Bulletin Board: 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.
Avicena Group, Inc.
avicenagroup