ANN ARBOR — Adeona Pharmaceuticals Inc. said Monday 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 in women.
The company also announced that Rhonda Voskuhl, M.D., director of the multiple sclerosis program at the University of California Los Angeles and lead Principal Investigator of this Phase II clinical trial, has funding available to continue enrollment at all 15 centers, increasing the power of the trial. It is anticipated that the remaining grant funding will allow for the enrollment of an additional 10 to 20 patients.
Said Voskuhl: “Of the 400,000 people in the U.S. afflicted with MS, approximately 85 percent 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.”
Added Adeona chairman and CEO James S. Kuo, M.D.: “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. 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.”
Estriol has been approved and marketed for over 40 years throughout Europe and Asia 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 through the third trimester of pregnancy compared to pre-pregnancy-rates, and that relapse rates increased by 120 percent during the first three months after birth 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.
Voskuhl has found that levels of estriol equivalent to pregnancy have potent immunomodulatory effects on MS. She has further shown in a small number of non-pregnant female MS patients that estriol may have a therapeutic benefit by regulating the immune system and thus reducing the relapse rates, similar to the response seen in MS patients during pregnancy.
The randomized, double-blind, placebo-controlled clinical trial of Trimesta has enrolled the original target of 150 patients and will continue to enroll patients at 15 centers in the United States. Investigators are administering either Trimesta or matching placebo in addition to glatimer acetate (Copaxone), an FDA-approved therapy for MS, to women between the ages of 18-50 who have been recently diagnosed with relapsing-remitting MS. Each MS patient will be dosed and monitored for two years after being enrolled in the clinical trial. With over $8 million in grant funding awarded to date, the ongoing Trimesta clinical trial should be funded to its completion.
Additional information regarding this trial is available at www.clinicaltrials.gov/ct2/show/NCT00451204.
Adeona is a pharmaceutical company focused on developing innovative medicines for the treatment of serious central nervous system diseases. Adeona is developing, or has partnered the development of, drug product candidates to treat multiple sclerosis, fibromyalgia, amyotrophic lateral sclerosis and Alzheimer’s disease.
More at www.adeonapharma.com.