ANN ARBOR, Mich., May 3, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (AMEX: AEN), a developer of innovative medicines for serious central nervous system diseases, announced today that after scientific review, the ongoing clinical trial of its Trimesta™ (oral estriol) drug candidate for multiple sclerosis (MS) has received an additional $1,594,553 in grant funding from the National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS). The clinical trial is led by Rhonda Voskuhl, M.D., Director, University of California, Los Angeles (UCLA) Multiple Sclerosis Program, UCLA Department of Neurology. Along with the recent grant award of $409,426 received from the National Multiple Sclerosis Society (NMSS), this NIH/NINDS grant award should support the ongoing Trimesta clinical trial to its completion.
"The goal of this clinical trial is to demonstrate a reduction in the rate of relapses in female MS patients with a treatment regimen of oral Trimesta added to the standard of care Copaxone®. MS is a debilitating disease, therefore, slowing the progression of the disease could potentially allow these patients to achieve a more normal quality of life," said Dr. Voskuhl. "We are very grateful to the NIH for supporting this important mission. Their commitment to pursuing estriol as a novel treatment for MS has been unwavering."
This ongoing clinical trial previously received a $5 million grant from the NMSS in partnership with the NMSS's Southern California chapter, with support from the National Institutes of Health, $860,440 in grant funding through the American Recovery and Reinvestment Act, and recent additional funding of $409,426 from the NMSS. In November 2010, Adeona announced that it was awarded $244,480 under the Qualifying Therapeutic Discovery Project Program to support research and development expenses related to the Company's MS program.
The 150-patient, randomized, double-blind, placebo-controlled clinical trial of Trimesta is currently underway 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. With 133 out of 150 patients enrolled in the clinical trial as of May 1, 2011, the Company anticipates full enrollment by the second half of 2011. Additional information regarding this multiple sclerosis clinical trial is available at http://www.clinicaltrials.gov/ct2/show/NCT00451204.
"We are very pleased that the Trimesta MS clinical trial has been awarded over $8 million in grant funding by organizations such as the NIH, NMSS and other third party groups. This support demonstrates independent scientific review of the clinical work being conducted by Dr. Voskuhl and provides funding for our MS program that is non-dilutive to our shareholders," stated James S. Kuo, M.D., M.B.A., Adeona's Chairman and CEO. "We are also excited to be exploring new opportunities with Dr. Voskuhl that could further expand our MS clinical program beyond the current trial."
About Adeona Pharmaceuticals, Inc.
Adeona is a pharmaceutical company 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. Currently, Adeona is developing, or has partnered the development of, the following product candidates: a prescription medical food for Alzheimer's disease, and drugs for multiple sclerosis, fibromyalgia and age-related macular degeneration. 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 grant award supporting the Trimesta clinical trial to its completion, the grant award further expanding the MS program, the potential effects of slowing the progression of the disease , our ability to produce a new, effective oral therapy for multiple sclerosis and the anticipated enrollment. 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, a lack of funding despite the recent grants, our failure to successfully commercialize a new oral therapy for multiple sclerosis, the availability of additional financial and other resources and the allocation of resources among different potential uses, a failure of our clinical trial to complete enrollment in the anticipated time period or to achieve desired results, our ability to initiate additional clinical programs for multiple sclerosis 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.