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IISc completes mice study for malaria drug, to seek DCGI clearance for clinical trials
Nandita Vijay, Bangalore | Friday, December 15, 2006, 08:00 Hrs  [IST]

In a major Plasmodium Falciparum malaria drug research programme in the country, Indian Institute of Science (IISc), the research partner has successfully completed the mice study using a combination therapy of curcumin (turmeric ) with Artemisinin derivative, Artesunate, and anti malarial agent. The coordinating agency National Institute of Malarial Research, New Delhi is seeking an approval from the Drugs Control General of India for the clinical trials on humans.

Artemisinin is a herb traditionally used in China to treat malaria. Out of the many combinations tested, Artesunate + curcumin is identified to be a potential drug if it works in humans, said Prof G Padmanabhan, scientist emeritus and former director Indian Institute of Science who is engaged in the study.

Among the centres identified for the trial along with IISc are Institute of Lifesciences in Bhubaneswar, an autonomous Institute of the Department of Biotechnology and Regional Centre for Tribal Research, Jabalpur. The blood samples will be tested at the Malaria Research Centre Field Station at Ranipur, Hardwar. Being a hospital based trial, the ISPAT Hospital; Rourkela, which is swarmed by malaria cases, would recruit the patients.

The phase I of the trial expected to commence in March 2007 will be on simple malaria cases (100 patients) that will be administered with curcumin+Artesunate combination, which will be tested against the Artesunate +sulphadoxine pyrimethamine(SP), which is an approved combination for malaria treatment. But if this combination of curcumin +Artesunate is proved efficacious, then it will be far more advantageous because SP is known to be drug resistant, said Prof. Padmanabhan.

The combination of curcumin+ Artesunate is a first-of-its-kind in the world.
Currently, the drug resistance of curcumin is being ascertained at the ISPAT Hospital where six normal volunteers' whose samples are undergoing analysis at Haridwar to ascertain their absorption properties. After this the research team will be able to finalize curcumin form(oil, powder and curcumin + Piperine blend) to be used in the trial. "The positive effect of curcumin on the patients could possibly allow lowering the dosage of Artesunate, in the drug study," said Prof Padmanabhan.

After the completion of phase I, complicated malaria cases will be identified for the phase II study. The research project is a Department of Biotechnology funded initiative where around Rs 75 lakh was disbursed.

The research on mice by IISc is published in the Anti Microbial Agents and Chemotherapy Journal of May 2006 and Patents have been filed both the US and India.

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