PHASE III TRIAL TO EVALUATE NEUROAID IN STROKE RECOVERY.
The CHIMES study is a multi-center double-blind placebo-controlled randomized trial to evaluate the efficacy of NeuroAid(TM) 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(TM) 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(TM) outside of China, said, "We are delighted at the interest NeuroAid(TM) has generated in the medical community worldwide. Over 200,000 patients in China alone are using NeuroAid(TM) 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(TM) included in key treatment guidelines for stroke victims, making its benefits available to all patients who need it," David added.
NeuroAid(TM)'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(TM) 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.
NeuroAid(TM) is a Traditional Chinese Medicine that provides faster and more extensive recovery of motor and cognitive functions in stroke patients during rehabilitation. It is a combination of fourteen all-natural ingredients from the Chinese medicinal pharmacopoeia, formulated according to international Good Manufacturing Practice (GMP) standards. It is marketed internationally by Moleac, the biopharmaceutical company that identified the product in China as the first medicine to help improve stroke recovery. NeuroAid(TM) is currently marketed in Singapore as a Chinese proprietary medicine, and in other countries in the region as a dietary supplement.
It is also sold internationally by Moleac via the website http://www.neuroaid.com.
With the CHIMES study, NeuroAid(TM) is the first traditional medicine in the world to be studied in a large scale evidence- based clinical trial.
Moleac is a biopharmaceutical company based in Biopolis, a world-class purpose built complex for biomedical sciences research in Singapore. Moleac identifies promising medicines discovered in China and develops them into Western mainstream medicine. Moleac also develops innovative technologies and medical products in-licensed from Europe and the US, and markets them in Asia. Focusing on patients' greatest needs and specific unmet medical needs, Moleac drives research, development and registration for a pipeline of drugs and devices in various stages of development. Moleac seeks partners to bring these products to market and will continue to evaluate new opportunities.
For more information, visit http://www.biopolis.com.sg.
Moleac's first product derived from Traditional Chinese Medicine, NeuroAid(TM), has gained market approval in two countries in 2006 and will be available to stroke sufferers around the world in 2007-2008. Moleac also plans the launch of a smoking cessation therapy that will reach key global markets in 2007.
About CHIMES Society
CHIMES Society is an international partnership of Key Opinion Leaders in stroke whose objective is to establish new stroke treatments. Members include physicians, academics, and clinicians, several of which are renowned neurologists from Europe and Asia. The team received a grant from the National Medical Research Council (NMRC) of Singapore to undertake the study over a period of two years.
For further information visit, http://www.chimes-society.org.
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|Article Type:||Clinical report|
|Date:||Nov 1, 2007|
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