Avicena Announces Phase III ALS Trial Results
ALS-02 Demonstrates Positive Mortality Trend
Palo Alto, CA, May 9, 2006 — The Avicena Group, Inc. (OTCBB: AVGO) (Avicena), a
developer of novel pharmaceutical and therapeutic products, announced today results of a
Phase III trial of its drug candidate, ALS-02, for the treatment of amyotrophic lateral
sclerosis (ALS or Lou Gehrig’s disease). Study data showed no statistically significant
difference between ALS-02 (five grams per day) and placebo with regard to the study’s
primary and secondary endpoints (various measures of muscle strength, muscle fatigue
and functional scores). However, in a separate analysis when mortality data was
combined and analyzed with mortality data from a second study of ALS-02 previously
conducted by the North East ALS Consortium (NEALS), the analysis demonstrated a
positive trend toward decreased mortality in subjects receiving ALS-02. The compound
was also found to be safe and well-tolerated by patients.
“We are very interested in further exploring this trend toward decreased mortality,” said
Belinda Tsao-Nivaggioli, Ph.D., Avicena’s chief executive officer. “We intend to
explore whether these findings can be expected to impact the remaining regulatory path
for the compound.”
In a separate analysis, investigators are currently combining data on all outcome
measures from the recently completed phase III trial, led by Jeffrey Rosenfeld, M.D.,
Ph.D., director of the Carolinas ALS Center, with data from the previously completed
phase II trial of ALS-02, led by Jeremy Shefner, M.D. and conducted by NEALS. A
comprehensive meta analysis is also being planned to combine data from all formal trials
in which ALS-02 was used as an experimental therapeutic agent in ALS. Upon
completion of the meta analysis, Avicena intends to discuss the findings, including the
mortality trend, with the United States Food and Drug Administration (FDA) in order to
determine the appropriate next development steps for ALS-02.
“We are hopeful that together with FDA we will be able to identify a clear path to market
for ALS-02,” stated Dr. Tsao-Nivaggioli. “It is important to note that the one currently
approved treatment for patients suffering from ALS offers only limited, short-term
survival benefit and has not demonstrated benefit in regard to measures of muscle
strength and neurological function.”
Additionally, in previous studies conducted in other neurodegenerative conditions such as
Huntington’s disease, data suggest that Avicena’s proprietary creatine-based therapeutics
may be significantly more efficacious at higher doses, without causing an increase in
adverse effects. As such, Dr. Allitia DiBernardo and the NEALS consortium, with
Avicena, are presently planning a dose-escalation study of ALS-02, which is being
designed to determine the optimal treatment dosage within the ALS patient population.
Avicena’s Phase III study of ALS-02 was a multi-center, double-blind, placebocontrolled,
randomized trial designed to evaluate the safety and efficacy of the compound
at a dose of five grams per day for nine months. The trial was supported by the National
Institutes of Health’s National Center for Complementary and Alternative Medicine.
ALS-02 is a proprietary therapeutic that incorporates an ultra-pure, clinical form of
creatine. The compound was granted orphan drug designation by FDA in 2002.
Amyotrophic Lateral Sclerosis (ALS), also known as "Lou Gehrig's disease," is a
progressive 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. There are
approximately 30,000 individuals suffering from ALS in the United States at any one
time. There is presently no known cure for ALS.
CTD has been shown to affect both males and females. However, the severity of the mental retardation is significantly magnified in male patients due to the fact that the defect is located on the X-chromosome, of which males have only one. Female CTD carriers (mothers and sisters of male CTD patients) appear to have only partial function of the transporters and as a result, can suffer from lower cognitive function than the general population, but higher than male CTD patients. Due to these differences, treatment of CTD will differ between genders.
Based in Palo Alto, CA, Avicena is a biotechnology company that seeks to develop and commercialize therapeutic products that regulate the critical energy processes which occur within human cells. Avicena's focus is on the development of pharmaceutical products to treat patients with rare diseases (orphan drugs), as well as dermaceutical products. To date, the company has advanced certain compounds for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) into Phase III trials and treatments for Huntington's disease (HD) into Phase II development. Having completed Phase II trials, the company is now considering a Phase III trial for the treatment of Parkinson's disease.
This release may contain forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements reflect, among other things, management's current expectations, plans and strategies, and anticipated financial results, 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" in the company's prospectus 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 early state 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.
Vida Communication (on behalf of the Avicena Group)
Stephanie Diaz (investors)
Tim Brons (media)