The Hindu Business Line : Biocon begins phase-II trials of cancer drug

The drug is a humanised monoclonal antibody (MAb) used in the treatment of head and neck cancers and the company has received all necessary pre-trial approvals from the authorities concerned. The data is posted on the company Web site, it said in a release.

TheraCIM is one of the eight products being developed for the Indian market under Biocon Biopharmaceuticals, the venture with the Cuban R&D partner CIMAB. It has already received a fast-track approval from the National Regulatory Authority of Cuba and `orphan drug' status from the European Agency for the Evaluation of Medicinal Products to treat cancer patients.

MAbs, considered future therapeutics, attack cancer-causing receptors and form a new line of cancer treatment along with radiotherapy and chemotherapy.

Once the tests are through, Biocon Biopharmaceuticals will produce the MAbs in its large biological facility, expected to be ready in the second half of 2005.

Ms Kiran Mazumdar-Shaw, Biocon CMD, said, the development "marks a substantial advancement in Biocon's recombinant bio-therapeutic portfolio and brings us closer to commercialising the first such proprietary product."

Worldwide, head and neck cancers have a high incidence of half a million new cases annually, with nearly 2.5 lakh deaths.

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