Shasun Pharmaceuticals, which is engaged in pre-clinical animal trials for cancer therapy using gold nano particles, hopes to begin human trials in the country next year.
The $2-million initiative is being undertaken in association with US-based Nanoparticle Biochem Inc, with the support of University of Missouri.
The project's aim is to kill cancer cells instantaneously by injecting radioactive gold nano particles into solid tumours, without the need for external chemo or radiotherapy. The nano particles can be used in the treatment of oral and prostate cancer.
Shasun's research units in Chennai and Puducherry are working on the optimum protocol for breaking gold rods into nano particle form. Trials are being undertaken in the US on dogs, swine and mice.
“Initial toxicity studies on swine, mice and rats indicate good tolerance to loading of molecules without side-effects. Efficacy studies on dogs have also shown good response,” said Mr Jatin Vimal, Vice-President - Biotech & Nanotech.
More animal trials will continue; Shasun will present its findings by December to the Indian drug authorities for approval, upon which it can start clinical trials on patients afflicted with oral cancer.
“We will seek a pathway from the authorities for bringing the drug to the market. We hope to start human trials at hospitals in India by March next year,” said Mr Vimal.
Shasun would probably require the help of Bhabha Atomic Research Centre in handling radioactive particles.
The company will simultaneously start human trials in the US for prostate cancer, pending USFDA nod.
Shasun will have world-wide rights over the technology; $1 million has been invested so far. It could take two years before the product is available in the market.
This could be the first nano drug from India. World-wide, only one nano particle cancer drug has been approved – in the US.