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P.T. Jyothi Datta

Mumbai , June 13

THE Hyderabad-based Shanta Biotechnics expects to start its first phase of human trials on monoclonal antibodies by August.

Monoclonal antibodies are laboratory-created substances that can locate and bind with cancer cells.

Shanta Biotech expects to conduct clinical trials on these substances targeting non-small-cell lung, pancreatic, colon, and breast cancer, respectively.

"We have four molecules - RM 1, 2, 3 and 4, and phase I clinical trials are expected to commence in the US by August," said Mr K. I. Varaprasad Reddy, Managing Director. "On a parallel level we will look to commence phase I trials in India too and are taking the (regulatory) permissions required."

Unlike the strategy that is popular with pharmaceutical companies, Shanta is not looking to licence out the molecule for further development, if it achieves positive results initially.

"We will look to take the molecule through phase III to the market for commercialisation," he said.

Monoclonal antibodies are therapeutic agents that assist in targeted treatment of cancer.

Studies are being conducted to see whether monoclonal antibodies when attached to chemotherapy drugs or radioactive substances can seek out antigens unique to cancer cells and deliver these treatments directly to the cancer.

This way, it would kill the cancer cells without harming healthy tissue.

The first phase of human trials involves testing the molecule on about 50-100 healthy human volunteers to evaluate the safety profile and dosage range of the drug.

More than a couple of years ago, Shanta had introduced human interferon alpha, also for cancer patients.

According to an analyst, the human trials on monoclonal antibodies will strengthen Shanta's oncology portfolio.

But if a product is finally brought to the market, it will bring a drop in prices in the same segment.

Shanta's corporate strategy has been to bring products into the market at a price lower than the existing market price, as was seen with the Hepatitis B vaccine and interferon.

The latter was launched at a price 40 per cent less than its imported counterparts.

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