Adeona receives additional funding for multiple sclerosis trial
Posted Jan 16 2010 6:44am
Jan 11, 2010 (Datamonitor via COMTEX) --
Adeona Pharmaceuticals has reported that the ongoing clinical trial of its Trimesta drug candidate being conducted by Rhonda Voskuhl, director of UCLA multiple sclerosis program at the UCLA department of neurology, has received an additional $860,440 in grant funding through the American Recovery and Reinvestment Act.
Investigators will administer Trimesta along with 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.
This ongoing clinical trial previously received a $5 million grant from the National Multiple Sclerosis Society in partnership with the National MS Society's Southern California chapter, with support from the National Institutes of Health.
In the current Phase II/III study, Trimesta is being given orally once-a-day versus placebo to 150 female relapsing-remitting MS patients in combination with a standard of care background therapy, subcutaneously injected glatimer acetate.
The primary endpoint for the study will evaluate effects of the treatment combination on relapse rates at two years with a one year interim analysis using standard clinical measures of MS disability as well as secondary endpoints of magnetic resonance imaging measurements of brain lesion and effects on cognition. The study is approaching a 50% enrollment with the rate of enrollment benefiting significantly from the expansion of clinical sites.
Dr Voskuhl said: "This additional funding has already had a very positive impact on our trial. It has greatly increased the rate of enrollment by supporting the addition of nine more clinical sites, bringing the total up to 16 sites across the US. We were extremely pleased that our trial was deemed important enough to be supplemented with these additional funds."