The Department of Biotechnology (DBT) supported Plasmodium Falciparum malaria drug research programme is gearing up for the pre-phase I study to provide a pre-clinical toxicity data on 60 patients. The mice study was completed in December 2006 and the data was submitted to the Drugs Controller General of India (DCGI) for an approval for phase I. The trial, which was expected to take off in March this year, has been delayed because the DCGI approval is pending.

In view of the impending delay, the six partners of the project namely National Institute of Malarial Research, New Delhi(coordinating agency), Institute of Lifesciences, Bhubaneswar, (an autonomous Institute of DBT), Regional Centre for Tribal Research, Jabalpur, Indian Institute of Science (IISc), Bangalore, Malaria Research Centre Field Station at Ranipur, Hardwar and ISPAT Hospital, Rourkela are undertaking the Pre phase I study and this report will also be submitted to DCGI to prevent further hold up.

"There is an apprehension among the six institutes that DCGI delayed the trial approval for want of pre-clinical toxicity study hence we would submit the data in a few weeks. We are already behind schedule and do not intend to lose any more months for want of data, Prof G Padmanabhan, scientist emeritus, former director Indian Institute of Science and co-coordinator for the malaria drug project told Pharmabiz.

"For the study, 30 patients will be administered with Artesunate an Artemisinin derivative, and remaining 30 with Artesunate along with + curcumin (turmeric). The main objective is to ascertain the toxicity levels of the drug in a combination therapy. While Artesunate is already used as an approved drug globally, curcumin has no toxicity levels, yet it is still crucial to ascertain the Artesunate +curcumin combination details. Although we are confident that there will be no toxicity issues, yet we would prove the same to the regulatory authority. Not only that DCGI recently cleared a cancer drug with a combination of curcumin with Paclitaxin. Hence we see no problems in clearing this, informed Prof. Padmanabhan, scientist emeritus and former director, IISc who is modulating the research project.

The trial is to ascertain the efficacy and safety of Artemisinin derivative, Artesunate, an anti-malarial agent in combination with curcumin (turmeric) on humans. The study on mice has been successfully completed and IISc, which is the research hub of the study, is now trying to assess the dosage of Artesunate. Global statistics report that if Artesunate is given as a stand alone drug, recurrence is 15 per cent in a patient population of 100, while Artesunate with curcumin has only 5 per cent returning for treatment.

This Rs 90 lakh funded DBT research has an industry partner (name withheld) who is working on the drug delivery modes which could either blister packs or pellets in capsules, stated Prof Padmanabhan.

At IISc's Biochemistry department other malaria initiatives are discovery of metabolic HEME pathways for which genes are cloned as these are proving to be unique drug targets, stated Padmanabhan whose is only keen to work on suitable drug for the disease which affects 600 million globally where India accounts for 3 million cases out of which 10, 000 fatal annually with children being the major victims.

The key issue is drug resistant malaria. A lot of global research is on and India has several scientific groups involved in the development of vaccines and drugs apart from looking at vector control options, stated Prof. Padmanabhan.