Ann Arbor-based 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 Program, part of the federal health care reform law enacted earlier this year. The grants will support the company’s Alzheimer’s disease and multiple sclerosis treatment programs currently in clinical testing.
These grants represent approximately 38 percent of the company’s total research and development expenses based on trailing 12-month calculations.
In October, 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 percent patient enrollment. Patients are assessed three and six 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 www.clinicaltrials.gov/ct2/show/NCT01099332.
In August, 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 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 CEO.
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 percent 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.
Adeona is a pharmaceutical company developing innovative medicines for the treatment of serious central nervous system diseases. 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.
More at www.adeonapharma.com.
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