Survival Data for Avicena's Amyotrophic Lateral Sclerosis Drug Candidate, AL-02, to be Presented at 18th International Symposium
October 18 2007 - 8:30AM
PR Newswire (US)
PALO ALTO, Calif., Oct. 18 /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 data related to
the Company's Amyotrophic Lateral Sclerosis (ALS) drug candidate,
AL-02, will be presented at the 18th International Symposium on
ALS/MND which will be held on December 1-3, 2007, in Toronto,
Canada. The poster presentation by Allitia DiBernardo, M.D. of
Massachusetts General Hospital will discuss a pooled analysis of
survival data from three randomized, placebo-controlled studies.
Results suggest a trend towards increased survival in patients
taking AL-02. The combined analysis examined three trials and
included a total of 386 patients. The three trials were conducted
by the Northeast ALS Consortium (NEALS), Carolinas Medical Center
and Utrecht University. The pooled analysis showed an increase of
1.47-fold in median survival compared to results in patients taking
a placebo. Certain portions of these data were presented to the FDA
and formed the basis for Avicena's intent to initiate a
confirmatory Phase III trial in 2008. This study will evaluate
AL-02's effect on the primary endpoint of median survival and
secondary endpoints of ALS functional scores. "These data points
support AL-02's positive effect on the survival rate of ALS
patients," stated Belinda Tsao-Nivaggioli, Chairman and C.E.O. of
Avicena. "We are very encouraged by these results and we will
continue to advance AL-02 towards commercialization, as well as our
drug candidates for Parkinson's and Huntington's disease. AL-02
will be the Company's third late-stage drug candidate." ABOUT ALS
ALS is a neurodegenerative disease that attacks the motor neurons
of the brain and spinal cord that are responsible for voluntary
muscle movement. As these motor neurons degenerate, their ability
to send impulses to the muscle fibers is compromised. With an
incidence rate of approximately 1 in 10,000, ALS affects roughly
30,000 Americans at any given time. Each year, approximately 5,600
new cases of ALS are diagnosed. The two types of ALS are "sporadic
ALS," which accounts for approximately 85% - 90% of all cases; and
"familial ALS," which accounts for the remaining 10% - 15% of
patients. A progressive degeneration of motor neurons eventually
leads to neuron death resulting in the brain's inability to
initiate or control muscle movement. Once a patient's muscles no
longer receive the messages that they require to function, muscles
begin to atrophy. ABOUT AVICENA Avicena Group, Inc. (OTC:AVGO)
(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). Near term, the Company plans to initiate a
confirmatory Phase III trial in ALS and a Phase III trial in
Huntington's disease 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) Sara Ephraim (investors) (646)
536-7002 Janine McCargo / Jason Rando (media) (646) 536-7033 / 7025
or DATASOURCE: Avicena Group, Inc. CONTACT: investors, Sara
Ephraim, The Ruth Group, +1-646-536-7002, , for Avicena Group,
Inc.; media, Janine McCargo or Jason Rando, +1-646-536-7033 or
7025, ,
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