Biocon Limited has commenced phase II clinical trials of its drug TheraCIM (h-R3), a humanised monoclonal antibody, for the treatment of head and neck cancers, after obtaining all the necessary approvals from the concerned authorities. Biocon has also announced that all clinical trial data pertaining to this drug were posted on the company website.
The drug has already received a Fast Track approval 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, company officials informed.
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 (h-R3) in the Indian market, informed Kiran Mazumdar-Shaw, chairman and managing director, Biocon Limited.
She added, "Biocon has commenced phase II clinical trials of TheraCIM (h-R3) for head and neck cancers. This marks a substantial advancement in Biocon's recombinant bio-therapeutic portfolio and brings us closer to commercializing the first such proprietary product. The data posted online is testimony to the safety and effectiveness of TheraCIM (h-R3) monoclonal antibodies to treat head and neck cancers and a reiteration of our core policy of transparency."
There are half a million new cases annually with nearly 250,000 deaths occurring. 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 7,00,000 new cancer patients every year and half of them do not survive. Karnataka has 150,000 cancer patients and approximately 35,000 people get the disease every year.