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 Rhonda Voskuhl, M.D., Director, University of California, Los Angeles (UCLA) 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.
"We are very pleased to announce the initiation of this new clinical trial that will evaluate our drug candidate Trimesta," said James S. Kuo, M.D., M.B.A., Adeona's CEO and President. "Results from the ongoing Phase II relapsing-remitting MS clinical trial and this new Phase II clinical trial for cognitive dysfunction in MS patients should provide results within the same time frame. Expanding the clinical development of Trimesta in the United States to include cognitive benefit should broaden the potential treatment options for women suffering from MS and should increase the economic opportunity for our drug candidate."
About Trimesta™ (oral estriol)
Trimesta is Adeona's proprietary drug candidate for the treatment of relapsing-remitting MS and for cognitive dysfunction, both in female patients. Estriol has been approved and marketed for more than 40 years throughout Europe and Asia for the treatment of post-menopausal hot flashes. It has never been approved in the United States by the Food and Drug Administration (FDA) for any indication.
On September 19, 2011, Adeona announced that the 150th patient has been enrolled in the randomized, double-blind, placebo-controlled, multi-center clinical trial of its Trimesta drug candidate for relapsing-remitting MS in women, per the original protocol. The Company also announced that Dr. Voskuhl had received funding to continue enrollment of an additional 10-20 patients at all 15 centers.
About Cognitive Dysfunction in Multiple Sclerosis
According to the National Multiple Sclerosis Society and the Multiple Sclerosis Society of Canada publication, Hold that Thought! Cognition and MS, it is fairly common for people with multiple sclerosis to complain of problems remembering things, finding the right words, concentrating on a task or something they are reading, or following a conversation. These are all cognitive symptoms of multiple sclerosis. Fifty to sixty-five percent of those affected by multiple sclerosis have cognitive dysfunction. Despite the fact that most symptoms are mild to moderate, they can have a significant impact on a person's ability to normally function. The overall cognitive dysfunction can be described as a reduction in mental "sharpness."
The major areas of cognition that can be dysfunctional include what are termed complex attention and executive functions. Complex attention involves multitasking, the speed with which information can be processed, learning and memory, and perceptual skills; executive functions include problem solving, organizational skills, the ability to plan, and word finding. Just as the nature, frequency, and severity of multiple sclerosis-related physical problems can widely vary, not all people with multiple sclerosis will display these cognitive issues, and no two people will experience exactly the same types or severity of problems.
About the Phase II Trimesta™ Clinical Trial for Cognitive Dysfunction in Multiple Sclerosis
The randomized, double-blind, placebo-controlled clinical trial of Trimesta is expected to enroll 64 relapsing-remitting or secondary-progressive female MS patients at UCLA. Those between the ages of 18 and 50 will be randomized 1:1 into the treatment and placebo groups. Dr. Voskuhl will administer either oral Trimesta or a matching placebo, in addition to any FDA-approved standard MS treatment. Each patient will be dosed and monitored for one year after being enrolled. The primary endpoint is better cognition scores in the Trimesta group versus the placebo group based on PASAT cognitive testing scores. Detailed information regarding this clinical trial, including contact information for the clinical site, is available at http://www.clinicaltrials.gov/ct2/show/NCT01466114.
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 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," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "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 timing of results for the two studies and benefits of expanding the clinical development of Trimesta. 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 failure of the clinical trial to provide desired results, our failure to successfully commercialize a new oral therapy for cognitive dysfunction in 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.|
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