Avicena Announces Positive Phase II Data for a Combination Trial Involving AL-08 for the Treatment of Amyotrophic Lateral Sclero
December 03 2007 - 10:00AM
PR Newswire (US)
Selected Therapy Can Advance to Phase III Clinical Trial PALO ALTO,
Calif., Dec. 3 /PRNewswire-FirstCall/ -- Avicena Group, Inc.
(OTC:AVGO) (BULLETIN BOARD: AVGO) , a late-stage biotechnology
company that develops central nervous system therapeutics for
neurodegenerative diseases, today announced positive Phase II data
for a combination trial involving AL-08, the Company's second
generation proprietary drug candidate for the treatment of ALS. The
purpose of the trial was to determine which of two compounds used
in combination with AL-08 would yield the most favorable results,
so that the Company could proceed to a Phase III trial. Results
were presented by Paul H. Gordon, MD of Columbia University in a
presentation titled "Combination Drug Selection Trial in
Amyotrophic Lateral Sclerosis" at the 18th International Symposium
on ALS/MND in Toronto, Canada on December 3, 2007. This study was
funded by the ALS Association, Ride for Life, and the Russ Bowen
and Spina Family Foundations. The Phase II trial evaluated the
neuroprotective capacity of two combinations, AL-08 and minocycline
versus AL-08 with celecoxib, using group sequential design and a
natural history control group for a futility analysis. The primary
objective of the trial was selection of a treatment based on which
drug combination appeared to slow deterioration in the ALS-
Functional Score. Results showed that patients taking the
AL-08/celecoxib combination showed a smaller mean decline in ALS-
Functional Score compared to those taking the AL- 08/minocycline
combination. Results also showed that the AL-08/celecoxib
combination was non-futile compared to historical controls, and
merits further evaluation. The trial was concluded ahead of
schedule after the first pool of patients met the selection
criteria. "We are encouraged that the AL-08/celecoxib combination
showed less of a decline in ALS-Functional Score compared to AL-08
and minocycline and historical control. Since the difference in the
ALS- Functional Score between the therapies tested was large
enough, and comparison to the historical controls was non-futile at
the 6-month time point, we were able to finish the trial early
after just 60 patients," stated Dr. Gordon. "We originally planned
to enroll up to 120 patients, in sequential pools of 60. Our
ability to halt the trial early underscores the potential efficacy
of AL-08, which can be further evaluated in a Phase III ALS
clinical trial." "We are pleased that AL-08/celecoxib slowed
deterioration in ALS- Functional Score compared to the other
treatment and believe that results of this trial highlight the
potential of this combination treatment for ALS patients," stated
Belinda Tsao Nivaggioli, CEO and Chairman of Avicena. "We are eager
to proceed with designing our Phase III clinical trial which will
attempt to confirm the efficacy of AL-08". About the Trial The
randomized, double-blind, selection trial targeted enrollment of up
to 120 patients in sequential pools of 60 to evaluate the
neuroprotective capacity of two drug combinations, AL-08/
minocycline and AL-08/celecoxib. The trial used a group sequential
design and a natural history control group for a futility analysis.
The primary objective was treatment selection based on which drug
combination appeared to slow deterioration in the ALS-Functional
Score. Patients were randomized to receive daily administration of
AL- 08/minocycline or AL-08/celecoxib. The trial was stopped early
after the first pool of 60 patients when the selection criteria was
met by showing a large enough difference in ALS-Functional Score
between the two treatment arms. Results showed that patients
treated with AL-08/celcoxib showed a smaller mean functional
decline versus AL-08/minocycline. At the end of the trial, the
decline in ALS-Functional Score in both treatment arms was compared
separately to the mean historical control group at a 0.05
significance level. The mean decline in ALS-Functional Score was
5.27 in the celecoxib/creatine arm, compared to 6.47 in the
minocycline/creatine arm, and 5.82 in the historical control group.
The trial's secondary objective was evaluation of futility, which
showed that AL-08/celecoxib was non-futile compared to historical
controls and the null hypothesis of at least a 25% reduction in the
ALS-Functional Score could not be rejected. This combination was
selected for a Phase III study. 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). 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(R)) Sara Ephraim (investors)
(646)536-7002 Janine McCargo / Jason Rando (media) (646) 536-7033 /
7025 or DATASOURCE: Avicena Group, Inc. CONTACT: Investors, Sara
Ephraim of The Ruth Group, +1-646-536-7002, , Inc., or Media,
Janine McCargo, +1-646-536-7033, , or Jason Rando, +1-646-536-7025,
, all for Avicena Group, Inc. Web site:
http://www.avicenagroup.com/
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