-- Alzheimer's Disease and Multiple Sclerosis Clinical Programs Advanced by Grants --
ANN ARBOR, Mich., Nov. 4, 2010 /PRNewswire-FirstCall/ -- Adeona Pharmaceuticals, Inc. (AMEX: AEN), a developer of innovative medicines for serious central nervous system diseases, announced today that it was awarded two grants totaling $488,959 under the Qualifying Therapeutic Discovery Project (QTDP) Program to support the Company's Alzheimer's disease and multiple sclerosis programs currently in clinical testing. These grants represent approximately 38% of the Company's total research and development expenses based on trailing twelve month calculations.
In October 2010, Adeona announced that Part 2 of its randomized, double-blind, placebo-controlled CooperProof-2 clinical study evaluating Zinthionein, a new zinc-based treatment for Alzheimer's disease, completed 100% patient enrollment. Patients are assessed 3 and 6 months after they begin the once-daily oral treatment or matching placebo, and all patients should complete their 6 month treatment by the end of March 2011. It is anticipated that the clinical study results should be available shortly thereafter. To date, there have been no significant adverse effects reported. If successful, Adeona expects to make its Zinthionein product commercially available as a prescription medical food for patients suffering from Alzheimer's disease and mild cognitive impairment. Further information on the clinical study is available at http://www.clinicaltrials.gov/ct2/show/NCT01099332.
In August 2010, Adeona announced that nearly two-thirds of the patients have been enrolled in the clinical trial evaluating Trimesta in women suffering from relapsing-remitting multiple sclerosis. The randomized, double-blind, placebo-controlled clinical trial to study the reduction in the rate of relapses is currently underway at 15 centers in the United States. The clinical trial has previously received approximately $5.9 million in grant funding. Further information on the clinical trial is available at http://www.clinicaltrials.gov/ct2/show/NCT00451204.
"We are pleased to receive these tax-free grants as they will enable us to advance our prescription medical food clinical study for the treatment of Alzheimer's disease and accelerate our clinical trial for the treatment of multiple sclerosis," stated James S. Kuo, M.D., M.B.A., Adeona's Chief Executive Officer.
About the Qualifying Therapeutic Discovery Project (QTDP)
As part of the Patient Protection and Affordable Care Act, Congress allocated $1 billion to the QTDP in March 2010, providing small and mid-sized biotech, pharmaceutical and medical device companies with up to a 50% tax credit or tax-free grant for investments in qualified therapeutic discoveries. A qualifying therapeutic discovery project is one designed to either treat or prevent diseases or conditions by conducting preclinical studies or clinical trials or carrying out research protocols for the purpose of securing approval from the Food and Drug Administration; or diagnose diseases or conditions or to determine molecular factors relating to diseases or conditions by developing molecular diagnostics to guide therapeutic decisions. It is expected that the QTDP should: enhance the potential to develop new treatments that address "unmet medical needs" or chronic and acute diseases; reduce long-term health care costs; represent a significant advance in finding a cure for cancer; advance U.S. competitiveness in the fields of life, biological, and medical sciences; or create or sustain well-paying jobs, either directly or indirectly.
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 has the following product candidates in development: a prescription medical food for Alzheimer's disease, and four drugs for multiple sclerosis, fibromyalgia, rheumatoid arthritis and dry 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," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," 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 completion of the Zinthionein clinical study by the end of March 2011, the expected commercial availability of the Zinthionein product and our ability to advance our prescription medical food clinical study. 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 Zinthionein clinical study to be completed on time or to achieve desired results, or a failure by us or our strategic partners to successfully commercialize Zinthionein and other factors described in Adeona's report on Form 10-K for the year ended December 31, 2009 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.