The Indian Institute of Science and National Institute of Malarial Research (NIMR), New Delhi coordinated drug research on Plasmodium Falciparum has gone in for phase-I trial after the Drugs Control General of India granted consent. The drug artesunate+curcumin combination which is a first of its kind is now being assessed for the toxicity effects.
The human study on healthy volunteers is being carried out by a clinical research organization (CRO), name withheld.
The trial will be on for a period of four months to assess the pre-clinical toxicity effects of the drug which is a novel combination of artesunate+curcumin and artesunate+biocurcumin. The latter is known for better bioavailability. Both curcumin and biocurcumin are being administered in different dose escalation. The dose escalation will help us to decide the ultimate combination, Prof G Padmanabhan, scientist emeritus, former director Indian Institute of Science and co-coordinator for the malaria drug project told Pharmabiz.
The double blind study will have two groups where three different dose escalations are going to be administered. Going by the human tolerance of the drug, Phase II for efficacy studies is expected to be carried out in April 2009.
The research which is a Department of Biotechnology (DBT) supported Plasmodium Falciparum malaria drug programme was provided with a funding of Rs 90 lakh up to the phase-I study. The research is driven by six partners: National Institute of Malarial Research, New Delhi the coordinating agency, Institute of Lifesciences, Bhubaneswar, which is 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 which carried out the Pre phase-I study submitted the results to the DCGI.
The researchers have also identified an industry partner to manufacture both curcumin and biocurcumin in tablet form.
"Since this combination has worked well in animal model, we are hoping it to be safe and efficacious on humans till phase-III. We are confident that the trials on both healthy volunteers and patients will be successful and allow us to look at a drug for malaria by at least 2011. Being a drug developed from a natural molecule, it will be extremely cost-effective in the treatment of malaria," stated Prof Padmanabhan.
Last month, the World Health Organization had called for the elimination of mono-therapy for malaria drugs and introduces the combination therapy using artesunate. It has recommended artesunate+lumefantrine combination which is a fixed dose artemisinin-based combination therapy. Another drug artesunate+ piperaquine is also being seriously pursued for the treatment of uncomplicated Plasmodium falciparum.
However the combination artesunate+curcumin is far superior in terms of efficacy with no drug resistance features supported by affordability in terms of being easily available, added Prof Padmanabhan.
Other malaria drug efforts at the IISc's Biochemistry department under Prof Padmanabhan include the discovery of metabolic HEME pathways for which genes are already cloned. They look different from the host and so it will prove as a good drug targets, informed Prof Padmanabhan.