Ann Arbor-based Adeona Pharmaceuticals Inc. announced Tuesday that after a scientific review, the ongoing clinical trial of its Trimesta oral estriol drug for multiple sclerosis has received an additional $1,594,553 in grant funding from the National Institutes of Health’s National Institute of Neurological Disorders and Stroke.
The clinical trial is led by Rhonda Voskuhl, M.D., Director, University of California, Los Angeles Multiple Sclerosis Program, UCLA Department of Neurology. Along with the recent grant award of $409,426 received from the National Multiple Sclerosis Society, this new 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,” Voskuhl said. “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. 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 under way 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 and 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, the company anticipates full enrollment by the second half of 2011.
Additional information regarding this multiple sclerosis clinical trial is available at www.clinicaltrials.gov/ct2/show/NCT00451204.
“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,” said James S. Kuo, M.D., , Adeona’s chairman and CEO.
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, visit www.adeonapharma.com.