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Cancer gene therapy gets go-ahead in India

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09/08/2007- A cell-based gene therapy that can be used for to treat renal cell carcinoma, colon, breast, and lung cancer, has been given permission to be used in Indian patients by the country's regulator.

The Indian Department of Biotechnology will allow this innovative therapy to be given to patients, based on existing preclinical and early-phase clinical data, without it having to undergo the usual regulatory approval process.

"This is because it is an individualised treatment so it is hard to manufacture and run trials in large numbers," a spokesperson from Mologen, the Berlin-based biotech company that developed the treatment, told BioPharma-Reporter.com.

"Patients, along with their doctors will have to decide whether they wish to take such a therapy… Within the next three years we hope to be providing the therapy for at least 400 patients a year."

India is the first country to give the go-ahead to such a gene therapy treatment and the spokesperson said that Mologen also has a partner in place in China and is hoping to have the therapy approved for use there within the next few months.

"We chose [to launch it in] these countries because their laws allow the use of such therapies, whereas most other countries do not."

Mologen is currently on the regulatory conveyer belt with the treatment in Europe, having conducted one PhaseI/II study already, with another one planned for next year, and the spokesperson said that it is hoping for approval from the European regulator (EMEA) within five years.

On the back of such data, the firm plans to eventually apply for regulatory approval in India and China, as although it is not required, it will facilitate an easier and wider distribution of the treatment to doctors and patients in these countries.

Meanwhile, following the green light, Mologen will immediately begin supplying the individualised therapy components (consisting of gene-modified cells and immunomodulators) to its licensing and marketing partner on the ground in India, Onco Life Sciences (OLS), who will then formulate the treatment for use in patients.

At the end of 2006, OLS paid Mologen an upfront payment of €2.1m for the partnership privilege, and following the Department of Biotechnology's decision, Mologen will now receive further payments for the supply of components.

Commenting on the decision, Prof. Burghardt Wittig, CEO of Mologen said: "It could serve as reference for further applications in other countries".

Cell-based gene therapy is an innovative approach now being taken by many companies in drug development. In the case of Mologen's treatment, foreign cancer cells (allogeneic tumour cells) are used to activate the patient's immune system in order to recognise and fight the tumour cells produced in the body.

To increase the efficiency of the immune system's defences, the allogeneic tumor cells are gene-modified to increase their recognition by the patient's immune system and in addition, immunomodulators are employed, which trigger a broad activation of the immune system. Thus the therapy helps to overcome the fatal tolerance of the patient's immune system to the cancer cells.

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