The phase I trial is designed to characterize the pharmacokinetic profile of two currently marketed drugs, identified by Stem Cell Therapeutics (SCT) as effective in non-clinical models of stroke.
SCT also has a phase II trial planned to evaluate safety and efficacy of its NTx-265 therapy in stroke patients. Now that formal approval from the Danish authorities has been received, screening of volunteers who will serve as trial subjects will be initiated in the near future.
Drug administration is expected to begin within 30 days of the first subject being screened. The study subjects will be dosed in two groups staggered by approximately two weeks. The duration of the phase I trial is anticipated to be eight weeks.
“This clinical development milestone for NTx-265 positions us closer to addressing the therapeutic needs of all stroke patients,” remarked Dr Alan Moore, Chief Clinical and Regulatory Officer of SCT.
Stroke is the third leading cause of death in the US and second worldwide and has an incidence of 700,000 victims in the US each year.