International Group Initiates Trial To Evaluate NeuroAid In Stroke Recovery
NeuroAid is the first natural compound to be studied in a large clinical trial focused on stroke recovery starting in the acute stage.
The CHIMES study is a multi-center double-blind placebo-controlled randomized trial to evaluate the efficacy of NeuroAid in reducing neurological deficit and improving independence in patients in rehabilitation, with treatment starting within 48 hours of a stroke. Already studied in a rehabilitation setting with initiation of treatment within 14 days of stroke incidence, NeuroAid will now be evaluated when administered in the acute stage, with periodic assessments for three months. The study will begin enrollment of 1,100 patients in early October 2007 at several hospitals in Singapore, followed by hospitals in the Philippines and in Thailand.
The study will be conducted by CHIMES Society, an international partnership of Key Opinion Leaders in stroke whose objective is to establish new stroke treatments.
Professor Marie-Germaine Bousser, Head of the Neurology Department at Lariboisiere Hospital in Paris, France and member of the Council of the American Stroke Association, commented, ''Recent drug trials in the acute treatment of stroke have unfortunately all been negative. It is thus very exciting to take a completely new approach and to scientifically test in different populations a compound that has long been used in Traditional Chinese Medicine.''
David Picard, CEO of Moleac, the Singapore/Biopolis-based global biopharmaceutical company that develops and markets NeuroAid outside of China, said: ''We are delighted at the interest NeuroAid has generated in the medical community worldwide. Over 200,000 patients in China alone are using NeuroAid every year, and patient feedback from other countries is very positive. Our next milestone is to generate clinical data in the acute phase, with studies that meet the standards of European and U.S. regulatory authorities.'' ''Our ultimate goal is to see NeuroAid included in key treatment guidelines for stroke victims, making its benefits available to all patients who need it,'' David added.
NeuroAid's efficacy and safety was tested in a multi-centre double blind randomized clinical trial conducted on 605 patients in China in 1999-2000. Patients taking NeuroAid were shown to be 2.11 times more likely to reach functional independence and 1.7 times more likely to reduce their neurological deficit by at least 55% than patients who did not take the product. It helped improve stroke patients' ability to recover even when treatment was started several weeks after the onset of stroke.