- Kolkata, India
- Rohit Khanna
Biotech firm Biocon Ltd is planning to submit the results of the post-marketing surveillance study (PMS) of its cancer drug, BIOMAB-EGFR, to the global safety database in US. The database, maintained by a consortium of companies, collects clinical trial data pertaining to the safety and efficacy of new drugs.
Dr Subir Basak, Biocon’s general manager for business development, said: “Head and neck cancer is not studied in the US, while the Indian sub-continent accounts for one-third of the head and neck cancer patients in the world. The PMS study report will be beneficial to the research of cancer the world over”.
The trial results for this drug, touted as being the world’s first humanised monoclonal antibody for cancer, have been published in Journal of Clinical Oncology of US in 2004.
The drug targets the human EGFR, a type of protein found on the surface of both normal and cancer cells. Small proteins circulating in the blood, called epidermal growth factors (EGF), bind with them. This binding stimulates certain biological processes within the cell to promote cell growth in a controlled manner.
In many cells, EGFR is overproduced, leading to abnormal growth. The role of EGFR in malignant cell formation has prompted the development of biological agents, like BIOMAB-EGER, which disrupts and inhibits the EGFR signaling process.
Apart from a large trial going on in North America, Biocon will start PMS trial in India soon. “Results have shown that while the FDA approved drugs increase life of cancer patients by a year at the most, BIOMAB-EGFR increases life by at least three years,” said Dr Basak.
BIOMAB-EGFR, the only monoclonal antibody manufactured in Asia, is indicated for use in combination with radiation therapy and chemotherapy in patients with positive expression of EGFR in squamous cell carcinoma of head and neck cancer.
“There is a scepticism in US about monoclonal antibodies manufactured in India. PMS trial results of the new drug will definitely sound a wake up call to them,” Basak added.