Federal study to use creatine



The company that makes the supplement has just 10 employees.
SAN JOSE MERCURY NEWS
SAN JOSE, Calif. -- Federal health officials said they have selected a tiny company's formula of a widely used nutritional supplement for use in a major study to see if it can slow the progression of Parkinson's disease.
Officials with the National Institute of Neurological Disorders and Stroke said they will use a highly purified form of creatine, developed by Avicena, in a study with 1,720 patients suffering from early-stage Parkinson's disease.
The federal study, to be conducted at 52 medical centers in the United States and Canada, is being called one of the largest ever for a potential Parkinson's treatment. Half the patients will be given Avicena's formula and half a placebo. The patients will be studied for up to seven years.
Company's response
Belinda Tsao-Nivaggioli, Avicena's chief executive officer, said the federal government's decision to use her company's treatment helps legitimize the work being done at Avicena, which was incorporated in 1999 and went public last year.
"We are very excited," she said, noting that her company has just 10 employees. "It gives us validation to our science."
If the study proves the company's treatment is effective, Avicena will seek to have it approved commercially by the U.S. Food and Drug Administration, Tsao-Nivaggioli added.
Avicena currently has one product on the market, Neotine, a nutritional supplement. It also plans to soon begin selling a skin treatment. Neither require FDA approval.
The company, which focuses on ways to maintain or alter the body's cellular energy, also is trying to develop treatments for such ailments as Lou Gehrig's disease, Huntington's disease and muscular dystrophy.
Parkinson's disease -- which affects more than 1 million people in this country -- is a degenerative brain disorder that causes a progression of symptoms, including tremors, slowness of movement and muscle stiffness. Although some drugs can ease its symptoms, no treatment so far has been shown to slow the progression of the disease.