ANN ARBOR, Mich.
Sept. 19, 2011
Adeona Pharmaceuticals, Inc. (AMEX: AEN), a developer of innovative medicines for serious central nervous system diseases, announced today that the 150th patient has been enrolled in the randomized, double-blind, placebo-controlled, multi-center clinical trial of its Trimesta™ (oral estriol) drug candidate for relapsing-remitting multiple sclerosis (MS) in women, per the original protocol. The Company also announced that
, M.D., Director,
University of California, Los Angeles
) Multiple Sclerosis Program, UCLA Department of Neurology, and lead Principal Investigator of this Phase II clinical trial, has funding available to continue enrollment at all 15 centers, therefore, increasing the power of the trial. It is anticipated that the remaining grant funding will allow for the enrollment of an additional 10-20 patients.
"We are excited to announce the enrollment of the 150th MS patient in this clinical trial, achieving our original targeted goal for enrollment. I am also very pleased that we have funds available to continue enrolling additional patients in this landmark MS trial," said Dr. Voskuhl. "Of the 400,000 people in the U.S. afflicted with MS, approximately 85% are initially diagnosed with relapsing-remitting MS, which is characterized by relapses, or attacks of declining neurologic function, followed by periods of remission. As we continue to dose and monitor each MS patient enrolled in the trial over a two year period, we would expect to demonstrate a statistically significant reduction in the rate of relapses in the patients treated with oral Trimesta."
"Completing enrollment in the Trimesta MS clinical trial as originally prescribed in the protocol is a significant milestone for Adeona and for MS patients, as it brings us one step closer to a potential treatment for women suffering from this devastating disease," stated
James S. Kuo
, M.D., M.B.A., Adeona's Chairman and CEO. "Once all of the patients have been enrolled and dosed for two years, we look forward to announcing Dr. Voskuhl's top-line results, and if positive, we would expect to seek FDA guidance on filing a New Drug Application."
About Trimesta (oral estriol)
Trimesta (oral estriol) is Adeona's proprietary drug candidate for the treatment of relapsing-remitting MS in women. Estriol has been approved and marketed for over 40 years throughout
for the treatment of post-menopausal hot flashes. It has never been approved by the FDA for any indication in
the United States
It has been scientifically documented that pregnant women with certain autoimmune diseases experience a spontaneous reduction of disease symptoms during pregnancy, particularly in the third trimester. The PRIMS (Pregnancy In Multiple Sclerosis) study, a landmark clinical study published in the
New England Journal of Medicine
followed 254 women with MS during 269 pregnancies, and for up to one year after delivery. The PRIMS study demonstrated that relapse rates were significantly reduced by 71 percent (p < 0.001) through the third trimester of pregnancy compared to pre-pregnancy-rates, and that relapse rates increased by 120 percent (p < 0.001) during the first three months after birth (post-partum) before returning to pre-pregnancy rates.
It has been hypothesized that the female hormone, estriol, produced by the placenta during pregnancy, plays a role in "fetal immune privilege," a process that prevents a mother's immune system from attacking and rejecting her fetus. Maternal levels of estriol increase in a linear fashion through the third trimester of pregnancy until birth, whereupon they abruptly return to low circulating levels. The anti-autoimmune effects of estriol may also be responsible for the beneficial effects of pregnancy on MS.