ANN ARBOR, Mich., Sept. 19, 2011 /PRNewswire/ -- 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 Rhonda Voskuhl, M.D., Director, University of California, Los Angeles (UCLA) 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 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 (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.
Rhonda Voskuhl, M.D., 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.
About the Phase II Trimesta Clinical Trial for Relapsing-Remitting Multiple Sclerosis
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 multiple sclerosis clinical trial is available at http://www.clinicaltrials.gov/ct2/show/NCT00451204.
About Adeona Pharmaceuticals, Inc.
Adeona is a pharmaceutical company focused on developing innovative medicines for the treatment of serious central nervous system diseases. The Company's strategy is to license product candidates that have demonstrated a certain level of clinical efficacy and develop them to a stage that results in a significant commercial collaboration. Adeona is developing, or has partnered the development of, drug product candidates to treat multiple sclerosis, fibromyalgia, amyotrophic lateral sclerosis (ALS) and Alzheimer's disease. The Company is currently preparing to make the following products commercially available: reaZin™, a prescription medical food for the dietary management of zinc deficiency associated with Alzheimer's disease, and wellZin™, a homeopathic over-the-counter medicine for reducing the duration and symptoms of the common cold. Adeona also operates Adeona Clinical Laboratory, a wholly owned clinical reference laboratory, that provides a broad array of chemistry and microbiology diagnostic tests. For more information, please visit Adeona's website at www.adeonapharma.com.
This release includes forward-looking statements on Adeona's current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "could," "potential," "positions," "continue," "expects," "anticipates," "intends," "plans," "believe," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding the expected results of the clinical study, the anticipated use of funding and adequacy of funding and any expected FDA guidance with respect to filing a New Drug Application. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Adeona's forward-looking statements include, among others, our failure to successfully commercialize a new oral therapy for multiple sclerosis, the availability of additional financial and other resources, a failure of our clinical trial to achieve desired results, our failure to obtain FDA approval of oral Trimesta for the treatment of MS and other factors described in Adeona's report on Form 10-K for the year ended December 31, 2010 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Adeona undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
|SOURCE Adeona Pharmaceuticals, Inc.|
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