The six institute coordinated combination drug research and development effort for malaria is now all set for phase I trails after Drugs Control General of India provided the formal consent early this month. The drug, artesunate+ curcumin combination, developed for malaria caused by Plasmodium Falciparum is a first-of-its-kind that is being tested for toxicity on healthy volunteers within a few weeks. The clinical research organization has been selected to conduct phase I study. The Department of Biotechnology had disbursed Rs 90 lakh up to the phase-I study. An industry partner has also been selected to manufacture both curcumin and bio-curcumin in tablet form.
The institutes partners are 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.
"There has been considerable delay in getting the permission from DCGI. We are way behind this research as phase II was supposed to commence in April this year. After the pre-phase-I study results submitted to the DCGI, there was an additional requirement of stability studies on the drug from the DCGI which was carried out by out by a team of pharmacologists. After this submission, we received the approval to carry out phase I. We are looking at around maximum 7-10 patients for phase I and hope to complete this study in two months to take it soon to phase IIa", Prof G Padmanabhan, scientist emeritus, former director Indian Institute of Science and co-coordinator for the malaria drug project told Pharmabiz.
The trials will be carried out in New Delhi and the details of the phase I study could hopefully be submitted to the DCGI by National Institute of Malaria Research so that before the year-end, we could be ready for phase IIa, he added.
For phase II-a, the researchers are looking at 50 patients to carry out trials. If the studies prove to be encouraging, efforts would be to immediately seek consent for the full fledged phase II study.
"With the World Health Organization insisting on combination drugs to treat malaria, we are keen to see the human trials take off successfully to provide treatment at a faster pace. The benefits of curcumin cannot be ignored. There is ample evidence on the formulations of curcumin derivatives increasing the bio-availability of the molecule and there are number of clinical trails underway also for cancer drugs carried out by many companies", stated Prof. Padmanabhan.
Artemisinin is based on extracts from the Chinese plant Artemesia annua (sweet wormwood). In fact, if the drug comes through it will be not only a safe and effective therapy but an affordable one for patients. Currently, malaria is affecting 600 million people globally and reporting one million fatal cases annually. There are only a handful of companies in the country producing malaria drugs including Intas, Cipla and Strides Arcolab.