Biocon Limited, has announced that it has commenced Phase II clinical trials of its drug TheraCIM, a humanised monoclonal antibody, for the treatment of head and neck cancers, after obtaining all the necessary approvals from the authorities concerned. The company has also published all clinical trial data pertaining to the drug. |
The drug has already received a fast track approzval from the National Regulatory Authority of Cuba and 'Orphan Drug' status from the EMEA (European Agency for the Evaluation of Medicinal Products) to treat cancer patients. |
According to Kiran Mazumdar-Shaw, chairman and managing director, Biocon Limited, "This announcement marks a substantial advancement in Biocon's recombinant bio-therapeutic portfolio and brings us closer to commercialising the first such proprietary product. The data posted online is testimony to the safety and effectiveness of TheraCIM monoclonal antibodies to treat head and neck cancers and a reiteration of our core policy of transparency." |
Monoclonal antibodies (MAbs) are spearheading a new line of effective cancer treatments along with conventional radiotherapy and chemotherapy. These novel drugs are engineered to attack receptors responsible for the origin and growth of cancer cells. |
Anticipating the increasing importance of MABs as future therapeutics, Biocon Biopharmaceuticals, Biocon's JV (joint venture) with the Cuban Institute CIMAB, plans to introduce TheraCIM in the Indian market. |
Exploring new treatments like TheraCIM MAbs is critically important given the high incidence of head and neck cancers worldwide. There are half a million new cases annually with nearly 2.5 lakh deaths. |
Further, it is estimated that globally about 9 million new cancer cases are diagnosed every year of which over half are fatal. |
In India, there are an estimated 7 lakh new cancer patients every year and half of them do not survive. |