The Department of Biotechnology (DBT) funded phase 1 study of the
combination drug artesunate+curcumin combination for Plasmodium
falciparum malaria will be completed by the year end.
“The drug
which is under phase I study with seven normal volunteers has found to
be well tolerated. We are not in a position to reveal any more details
at this point of time”, said Prof G Padmanabhan, scientist emeritus,
former director Indian Institute of Science and co-coordinator for the
country’s first ever malaria drug project.
There are six
institutes in the country: National Institute of Malaria Research, New
Delhi the co-ordinating 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 that are coordinating the research and development of
the drug.
“The combination of ‘artesunate+curcumin’ has been
developed to study if malaria caused by Plasmodium falciparum could be
controlled. Under the phase I study, the combination drug is being
assessed for its toxicity levels and tolerance studies”, he added.
A
clinical research organization has been overseeing the progress of the
study on healthy volunteers which are divided into three groups for a
double blind study, where the drug is administered in escalating doses.
“One
of the drugs, Artemisinin is based on extracts from the Chinese plant
Artemesia annual known as sweet wormwood. The other, curcumin is the
native turmeric. If this combination comes through successfully in all
the phases of clinical trials, patients can have access to a safe,
effective and affordable therapy”, pointed out Prof. Padmanabhan.
It
is estimated that malaria outbreak is known to cause one million deaths
in a 600 million of patient pool segment suffering from the mosquito
borne disease. In India, the south and eastern parts of the country are
reporting highest number of cases. Presently, only a few pharma
companies like Intas, Cipla and Strides Arcolab are engaged in the
manufacture of malaria drugs.
Pharmabiz had earlier reported that
DBT has provided Rs.90 lakh to the
phase-I study for which an industry partner was also chosen to produce
both curcumin and bio-curcumin in tablet form.
Once the phase I
study is completed and reports are submitted, the research institutes
will work towards carrying out phase II-a, involving 50 patients with
the consent from the Drugs Controller General of India.
In order
to tackle the growing menace of malaria, the World Health Organization
has been calling for the research and development of a combination drugs
to treat malaria. This is where the six research institutes in the
country are eager to ensure that human studies provide a positive answer
towards the combination drug, stated Prof. Padmanabhan.