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Amit Mitra

Mumbai , Dec. 17

BUOYED by the encouraging reports of its ongoing clinical trials in India for treatment of a rare breast cancer (HER 2 and ER/PR positive), Swiss pharma major, Roche, plans to set up new clinical trial sites in India as part of its global trials for treatment of a particular variant of lung cancer by the end of the next year.

Roche is planning to launch global trials for treatment of this particular variant of lung cancer, which involves "non-small cells" getting affected, using a combination of drugs that would include one of its own compounds, Avastin. One of the reasons for considering India is that it has a vast patient population infected by this type of lung cancer, which is primarily triggered by use of tobacco products.

With the clinical trials of Avastin nearing completion in the US, the drug will be launched in the US market by the first quarter of 2004. After this launch, the company will embark upon global trials for treatment of this variant of lung cancer, using a suitable combination of drugs with Avastin, by the end of next year.

India is also being considered a prospective site for Roche's future clinical trials involving new drugs and therapies for treatment of different variants of blood cancer and colorectal diseases.

Mr Henk de Wilde, Roche's global head for oncology clinical trials, told Business Line that the clinical trials for the breast cancer treatment was being conducted across seven sites in India, including Mumbai, Bangalore, Chennai, Ahmedabad and Cuttack. The Indian operations, being conducted by the Roche Scientific Company India Ltd, was part of the global trials across 140 sites in the US, Canada, the UK, France, Germany and other countries.

"This will be the first of its kind treatment for breast cancer patients having both HER 2 and ER/PR positive markers. Patients having an over-exposure of these markers are hard to find. While HER 2 positive cases account for 30 per cent of the breast cancer patients, those testing positive for both the markers are rare," Mr Wilde said.

The treatment primarily envisages use of a combination of Roche's anti-cancer drug, Herceptin, and Arimidex. "Reports are indicating that this treatment is working well in terms of increasing the life expectancy of the patients and, more importantly, without any side-effects. The treatment directly attacks the cancer-causing cells without influencing other organs. Generally, these patients suffer from side-effects like hair loss and weakening of the immune system with the existing therapies," he explained.

More than 26 patients have been recruited in India for the clinical trials, the largest number as compared to the patients recruited by the other 139 sites where the trials are being held. The company expects to wrap up recruitment of patients worldwide for the trials by March next year so that the phase III trials are completed by the first quarter of 2005. "We have so far got the best results from the Indian operations," Mr Wilde said.

As a matter of fact, India is emerging as a potential place for clinical trials, especially in the light of the availability of patients for treatment of different diseases. A string of global pharma majors have already set up sites for clinical trials in India.

"We have seen that we can save considerable time for clinical trials in India as compared to other countries due to availability of good quality manpower and a large patient population. We are also looking at China as another prospective place for clinical trials," Mr Wilde said.

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