ANN ARBOR, MI--(Marketwire - February 23, 2010) - Adeona Pharmaceuticals, Inc. (AMEX: AEN) announced today that the clinical trial of its investigational drug Trimesta™ (estriol oral) being conducted by principal investigator Dr. Rhonda Voskuhl (Director, UCLA Multiple Sclerosis Program, UCLA Dept. of Neurology) has enrolled over 75 patients. The total planned enrollment is 150 patients.
The Trimesta™ study is a double-blind, placebo-controlled clinical trial. Sixteen sites in the United States are currently enrolling patients. Investigators at these clinical sites are administering either Trimesta™ along with glatimer acetate (Copaxone®), an FDA approved therapy for multiple sclerosis, or a placebo plus glatimer acetate to women between the ages of 18 to 50 who have been recently diagnosed with relapsing-remitting multiple sclerosis.
The primary endpoint is relapse rates at two years with a one year interim analysis using standard clinical measures of multiple sclerosis disability. Secondary endpoints of magnetic resonance imaging measurements of brain lesion and effects on cognition will also be studied.
The Trimesta™ clinical trial has received a $5 million grant from the National Multiple Sclerosis Society in partnership with the National Multiple Sclerosis Society’s Southern California chapter, with support from the National Institutes of Health. In January of 2010, it was announced that an additional $860,440 in grant funding had been received allowing the number of clinical sites enrolling patients for this study to more than double to 16 clinical sites.
Trimesta™ has previously completed a 22-month, single-agent, crossover clinical trial in the United States for the treatment of relapsing remitting multiple sclerosis. The results showed the total volume and number of enhancing pathogenic myelin lesions (established neuroimaging measurements of disease activity in multiple sclerosis) decreased during the treatment period as compared to a six-month pretreatment baseline period. The median total enhancing lesion volumes decreased by 79 percent (p=0.02) and the number of lesions decreased by 82 percent (p=0.09) within the first three months of treatment with Trimesta™.
“We are encouraged with the accelerated pace of patient enrollment in the Trimesta clinical trial,” stated James S. Kuo, M.D., M.B.A., Adeona’s Chairman and CEO. “Based on the previous clinical trial results, we are hopeful that we will see an improvement in cognition in multiple sclerosis patients. Such a clinical finding would serve a compelling clinical need in these patients and highly differentiate the product from others currently in development.”
About Adeona Pharmaceuticals, Inc.
Adeona (AMEX: AEN) is a pharmaceutical company developing new treatments for serious central nervous systems diseases. Trimesta™ (estriol oral) is an investigational drug for the treatment of relapsing-remitting multiple sclerosis. A 16-center, double-blind, placebo-controlled clinical trial is currently underway. In December of 2009, Adeona initiated a 60 patient clinical trial of its patent pending oral gastro-retentive sustained release high dose zinc and cysteine formulation, Zinthionein™ ZC GS-150, for the dietary management of Alzheimer’s disease and mild cognitive impairment. Effirma™ (flupirtine oral) is a novel centrally-acting investigational drug for the treatment of fibromyalgia syndrome. It is ready for a proof-of concept clinical trial. For further information, please visit the company’s website at www.adeonapharma.com.
This press release includes forward-looking statements on Adeona’s current expectations and projections about future events (including the potential of Trimesta™ (estriol oral), and reflects Adeona’s current beliefs. 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 designing additional clinical trials for its oral zinc therapies, dnaJP1, Zinthionein, Zinthionein ZC, flupirtine, or Trimesta. As with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization and there can be no guarantee that any product will be commercially successful. Adeona is at an early stage of development and may not ever have any products that generate significant revenue. Adeona’s Hartlab subsidiary is generating modest revenues and its future success will likely depend upon its ability to successfully introduce and market new specialty diagnostic assays to generate additional revenues. 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 Adeona’s product candidates to be demonstrably safe and effective, a failure to obtain regulatory approval for the company’s products or to comply with ongoing regulatory requirements, regulatory limitations relating to the company’s ability to promote or commercialize its products for awareness, prevention, diagnosis or treatment of zinc deficiency and chronic copper toxicity, a lack of acceptance of Adeona’s product candidates in the marketplace, a failure of the company to become or remain profitable, that we will continue to meet the continued listing requirements of the American Stock Exchange (which, unlike other exchanges, does not require us to maintain any minimum bid price with respect our stock but does require us to maintain a minimum of $6 million in stockholders’ equity during the current year, for example), our inability to obtain the capital necessary to fund our research and development activities, a loss of any of our key scientists or management personnel, and other factors that are described in Adeona’s report on Form 10-K for the year ended December 31, 2008, Forms 10-Q for quarters ending in 2009 and in its other filings with the SEC. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Adeona undertakes no duty to update any forward-looking statements.
For Further Information Please Contact:
James S. Kuo, M.D., M.B.A.
Chairman, CEO and President
(734) 332-7800 X36
