ANN ARBOR, Mich.
Nov. 11, 2011
/PRNewswire/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of innovative medicines for serious central nervous system diseases, announced that the Company's drug candidate, Trimesta™ (oral estriol), will be utilized in a new Phase II clinical trial to evaluate its potential therapeutic effect on cognitive dysfunction observed in female multiple sclerosis (MS) patients. The Skirball Foundation and Adeona have pledged to equally support this clinical trial led by
, M.D., Director,
University of California, Los Angeles
) Multiple Sclerosis Program, Department of Neurology. The study, which focuses on cognition loss in MS patients, also received contributions from numerous supporters, such as the Sherak Family Fund, the Gustafson Fund, and the Diamont family.
"At some point, 50-65 percent of MS patients will develop problems due to cognitive loss, yet there remains no treatment to target this profound disability. Unfortunately, loss of cognition affects a person's ability to work and is the major reason MS patients stop or decrease their level of work," said Dr. Voskuhl, Principal Investigator. "We are therefore thrilled to begin this novel clinical trial of Trimesta in which the primary endpoint is improvement in cognition and the ultimate goal is to address an unmet need for these patients."
This new randomized, double-blind, placebo-controlled Phase II clinical trial is based on findings from a 10-patient, 22-month, single-agent, crossover clinical trial conducted by Dr. Voskuhl. The results from the crossover trial demonstrated a statistically significant 14% improvement from baseline in Paced Auditory Serial Addition Test (PASAT) cognitive testing scores (p = 0.04) in MS patients after six months of Trimesta therapy. PASAT is a routine cognitive test performed in patients with a wide variety of neuropsychological disorders such as MS.