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Avicena Group, Carolinas Neuromuscular/ALS-MDA Center Research on ALS Featured on “Healthy Solutions” National Television Series

July 23 2002

"NEOtine® Nourishes Nervous System” examines how Avicena’s creatine may help retard the progression of ALS (Lou Gehrig’s Disease) by replenishing energy in the brain, enabling brain cells to remain healthy and live longer. The segment, which aired as paid programming July 13 and 14 on CNBC and The Health Network, can be viewed online at the “Healthy Solutions” website, www.healthysolutions.tv, where visitors can watch the program on-demand, in full motion video.

Belinda Tsao-Nivaggioli, Ph.D., Avicena’s Vice President of operations, explains, “This is a story about energy, energy in the brain. The brain has high and flexible energy demands. When brain cells get sufficient energy, they remain healthy and live longer. When they don’t, the process of cell death begins.”

Avicena is currently supporting three clinical studies on the effects of creatine among ALS patients. Following a pilot study at Cornell Medical Center in 1999, ongoing Phase II/III studies with over 300 ALS patients started in 1999 at 29 sites, including The Carolinas Neuromuscular ALS/MDA Center in Charlotte, North Carolina.

ALS is a progressive neurodegenerative disease that attacks motor neurons, the components of the nervous system that connect the brain with the skeletal muscles,” explains Dr. Jeffrey Rosenfeld, Director of the Carolinas Neuromuscular ALS/MDA Center. “While we don’t have exact figures, our best estimates are that there are 5000 new cases diagnosed each year in the United States, or 14 new cases every day.”

Reviewing the research program, Dr. Rosenfeld said, “Avicena’s laboratory studies showed that creatine prolonged the life of motor neurons, the brain cells most affected by ALS, and extended survival. Now, in clinical studies with ALS patients, we are seeing some positive preliminary changes in muscle strength. Some patients are also reporting less fatigue."

Dr. Tsao-Nivaggioli highlights a recent milestone in the program, “In February we received Orphan Drug designation from the FDA for creatine in the treatment of ALS. This is the critical first step in bringing an orphan drug, one for a disease experienced by 200,000 people or less, to market. We are following this with a final clinical study and then plan to proceed to market.

About the Avicena Group:
Avicena is a private biotechnology company based in San Francisco, CA and Cambridge, MA, which is developing products based upon regulating cellular energy and/or mitochondrial energy processes. The company has an extremely rich intellectual property portfolio of 25 US patents and patent applications that also have extensive foreign filings.

About The Carolinas Neuromuscular/ALS-MDA Center:
The Carolinas ALS Center, located at Carolinas Medical Center in Charlotte, NC, is one of the most comprehensive ALS facilities in the United States. Through the interdisciplinary participation of key physicians and allied health care professionals, Carolinas ALS Center provides a high level of diagnostic services and coordinated care.

About Healthy Solutions:
"Healthy Solutions,” now in its seventh season, is an award-winning television series which explores the most important issues related to America’s health and well being. The series is produced and paid for by TV Interactive, an international leader in the production and distribution of multi-media television programming.