Moleac is pleased to announce the release of the CHIMES-E study results published online in the journal Cerebrovascular Diseases1 . It provides convincing data on NeuroAiD which confirm its persistent long-term benefits on patients’ recovery after an ischemic stroke. The CHIMES-E study results were first announced by Prof. Christopher Chen (CHIMES-E co-principal investigator) during the European Stroke Organization Conference (ESOC 2015) in Glasgow, April 17- 19, as part of the Scientific Program during the Clinical Trial session.
The CHIMES-E study is a planned, international and multicenter study performed in a blinded and placebo-controlled manner. It has included 880 patients from the CHIMES study who have suffered an ischemic stroke of intermediate severity within 72 hours, treated with NeuroAiD™ or placebo for 3 months after the initial stroke. The main purpose of this study was to evaluate the effects of an initial 3-month course with NeuroAiD™ on long-term outcomes for up to 2 years.
This study has showed that NeuroAiD™ increases significantly the odds of achieving functional independence at 6 months which persisted up to 18 months after stroke, as measured by the mRS. All these results were consistent at various time points and seen on 2 indices, i.e. mRS and BI. It also provided further long-term safety data on NeuroAiD™, even when combined with other stroke treatments. “These persistent benefits seen up to 18 months are a clinical confirmation of the previously established neurorestorative properties (i.e. neuroplasticity and neurogenesis) of NeuroAiD™, and suggest that it may be beneficial to extend NeuroAiD™ treatment beyond the first 3 months after stroke,” said Prof. Christopher Chen, neurologist at the National University of Singapore and the principal investigator of the CHIMES study. “The CHIMES-E study provides new insight on the need for long-term assessment of post-stroke recovery in clinical trials of agents with neuroprotective and neurestorative properties such as NeuroAiD.”
These results confirm the hypothesis raised by the CHIMES investigators: longer treatment duration and follow-up beyond 3 months of stroke patients is needed to assess stroke recovery2
About CHIMES Society
The CHIMES Society is an international academic industry collaboration with the objective to establish new stroke treatments. It is a Singaporean non-profit society founded by a group of experts in stroke and South-East Asian stroke clinicians interested to implement a research project: the NeuroAiD™ Efficacy on stroke recovery trial (CHIMES trial).
The CHIMES-E Study was supported by the CHIMES society and grants were received by CHLC from the National Medical Research Council in Singapore (NMRC) which supports the implementation of CHIMES trial in Singapore.
To address therapeutic gaps, Moleac has pioneered a new drug development approach, looking at sources of innovation from Natural Medicines, hence shortening considerably drug development cycle time and investment to bring medicine to sufferers’ unaddressed needs. Moleac’s neurorestorative compound NeuroAiD™ reaches patients in more than 30 countries.
For more information,
1- Venketasubramanian N, et al. CHInese Medicine NeuroAiD Efficacy on Stroke Recovery – Extension Study (CHIMES-E): A Multicenter Study of Long-Term Efficacy. Cerebrovascular Diseases 2015;44 39:309–318.
2- Venketasubramanian N, et al. Chinese medicine NeuroAiD efficacy stroke recovery-extension study (CHIMES-E study): an observational multicenter study to investigate the longer-term efficacy of NeuroAiD in stroke recovery. Cerebrovasc Dis 2013; 35(suppl 1):18–22.
|Sep 2007||The Business
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|Sep 2007||The Business Times||The Business Times Moleac plans to test traditional Chinese stroke drug.||EN|
|Sep 2007||Moleac announces CHIMES||Largest ever clinical trial on stroke recovery medication to be initiated in Singapore and Philippines.||EN|
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|May 2007||Medical News Today||Going West with Eastern Medicine.||EN|
|Apr 2007||AsiaOne||Chinese medicine to help stroke victims||EN|
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VIENNA, Austria — Long-term follow-up of a trial investigating a Chinese herbal supplement in patients with stroke suggests there may be some benefit after 6 to 18 months.
The Chinese Medicine NeuroAiD Efficacy on Stroke Recovery (CHIMES) study was an international randomized double-blind placebocontrolled trial of 3 months of treatment with the herbal supplement NeuroAiD (Moleac) started within 72 hours of symptom onset in 1100 patients with ischemic stroke.
The primary results, which were reported in 2013, showed a trend toward better functional outcomes in the treated group at 3 months, but this did not reach statistical significance.
Longer-term follow-up in the CHIMES-E (Extension) study, which reported outcomes up to 2 years in 880 patients, was reported by Narayanaswamy Venketasubramanian, MD, from the Raffles Neuroscience Centre, Singapore, here at the 24th European Stroke Conference (ESC).
“While the benefits of a 3-month treatment with NeuroAiD did not reach statistical significance for the primary endpoint at 2 years, the odds of functional independence defined as [modified Rankin Scale score] ≤ 1 was significantly increased at 6 months and persisted up to 18 months after a stroke,” he concluded.
The results were also published online April 22 in Cerebrovascular Diseases.
The CHIMES-E study population had an overall mean age of 61.8 years, with 318 (36%) women, and a mean baseline National Institutes of Health Stroke Scale score of 8.6. The treatment and placebo groups were balanced in baseline characteristics at the time of inclusion in CHIMES, and they were similar in terms of subsequent rehabilitation and intake of any Chinese herbal medicines during the study, the researchers state.
The primary endpoint of the extended follow-up study was the shift analysis on the modified Rankin Scale at 2 years. This was not significant but showed a trend toward benefit with NeuroAiD (odds ratio, 1.08; 95% confidence interval, 0.85 – 1.37; P = .543).
However, when analyzed according to patients showing a good functional outcome (modified Rankin Scale, 0 – 1), treatment was associated with significant benefit at the 6-, 12-, and 18-month points.
Dr Venketasubramanian noted that the Barthel index showed similar trends toward improvements in the treated group in the longterm follow-up. “So our results are consistent on more than one score.”
“It appears that a 3-month course of treatment may not show benefits immediately,” he commented to Medscape Medical News. “Our results suggest that we may have to wait a while to see the effects, and maybe treatment should be maintained longer term, to maximize effects.”
He added: “When the brain is injured it takes time to calm down, so differences in healing may take time to show up. The herbal extracts have shown neuroprotection and neuro-restoration properties in animal models. As the results appear to be delayed, this may suggest more restoration is taking place.”
The researchers are now in discussions about conducting a second trial with a longer period of therapy and a longer follow-up.
NeuroAiD is a combination of nine Chinese herbal extracts and nine animal components. A new formulation has recently been developed without the animal components, Dr Venketasubramanian said.
“We are hoping that the new formulation, which is manufactured in accordance with good clinical practice, will mean fewer tablets and a less expensive production process. It will also have the advantage of not needing the regulation necessary for animal products.”
Marketing information produced by Moleac claims that the herbal extracts contained in NeuroAiD have been shown to “stimulate brain self repair processes for stroke recovery.” This includes “increasing the number of mature neuronal cells” in mice models and “increasing neurite outgrowth and synaptogenesis” in neuronal cell cultures. It adds that the product reduced infarct volume in a rodent stroke model, increased cell survival, and “activates ATP-dependent K+ channels contributing to neuroprotection and ischemic preconditioning.”
The product is sold as an herbal supplement and is not regulated as a medicine at present.
The CHIMES-E study was supported by the CHIMES Society, a nonprofit organization, and grants were received by CLHC from the National Medical Research Council of Singapore. The authors received funding for the trial and accommodation and transportation support for meetings from the CHIMES Society. Moleac (Singapore) provided grants to the CHIMES Society, of which the society had sole discretion on use. One coauthor has minor shares in E*Chimes, the Philippine distributor of NeuroAiD. Other than CHIMES funding for the trial, the other authors and investigators have disclosed no relevant financial relationships.
Cerebrovasc Dis. 2015;39:309-318. Full text
24th European Stroke Conference (ESC). Presented May 14, 2015.