Biocon to start clinical studies for cervical cancer drug BIOMAb EGFR in India

BIOMAb EGFR, an anti-cancer drug developed by India’s Biocon Ltd, will be studied for use in cervical cancer.

Biocon has linked up HCG group of hospitals to conduct a study to evaluate the potential benefits of BIOMAb EGFR in cervical cancer patients.

BIOMAb EGFR is Biocon’s humanized monoclonal antibody which is currently approved for the treatment of head and neck cancers in India.

Biocon launched its first indigenously produced monoclonal antibody BIOMAb-EGFR in India in 2004.

Apart from head and neck cancer, Biocon is presently studying the efficacy potential of BIOMAb EGFR for various cancers like brain cancer (glioma), NSCLC, pancreatic cancer, gastric cancer and cervical cancer globally.

Studies with BIOMAb EGFR in NSCLC and glioma are currently ongoing in India.

The BIOMAb EGFR cervical cancer study will be conducted for six years in various centers of HCG across the country, involving many eminent oncologists and will be in compliance to ICH-GCP guidelines. The participating centers are Bangalore, Mysore, Vijayavada, Ranchi, Cuttack and Nashik.

The study will be conducted in a well controlled manner specifically keeping in mind the needs of the Indian patients which vary considerably from those of the West. Most treatment for this disease is currently based on data obtained from the western world. Biocon chose BIOMAb EGFR taking into account the safety profile this molecule has displayed in addition to results obtained in the other studies with this drug, the company said in a press statement.

Cervical cancer is the most common cancer among women in India and is the primary cause of cancer-related deaths in developing countries. To an estimated annual global incidence of 500,000 cervical cancers, India contributes 100,000, which is 1/5 of the world burden. Cervical cancer is responsible for more than 280,000 deaths annually worldwide. In India the number of deaths due to cervical cancer is estimated to rise to 79,000 by the year 2010.

Cervical cancer mostly affects middle-aged women (between 40 and 55 years), especially those from the lower economic status. Chemo radiotherapy has been shown in several studies to be more effective in terms of overall survival and local control, than radiation therapy alone in the treatment of women with locally advanced carcinoma of the cervix. But still the 2 year progression free survival is around 67 per cent and there is a need for further improvement.

Cervical cancer vaccine makers are betting big on India as the deadly cancer takes the lives of 8 women in India every hour.

GlaxoSmithKline has recently launched its cervical cancer vaccine Cervarix in India.

MSD Pharmaceuticals (India), the local affiliate of Merck & Co., Inc USA launched Gardasil a quadrivalent human papillomavirus vaccine.Gardasil is the only vaccine that helps protect against 4 types – types 6, 11, 16, 18 – of HPV. The vaccine helps prevent diseases such as cervical cancer; abnormal and precancerous cervical lesions, vaginal lesions, vulvar lesions; and genital warts, caused by these types of HPV, MSD said while announcing the launch.

HCG is now South Asia’s largest cancer care network of 17 centers. These are Bangalore Institute of Oncology, Bangalore,Bangalore Institute of Oncology Specialty Centre, Bangalore,Malnad Hospital & Institute Of Oncology, Shimoga, Karnataka,Bharat Hospital & Institute Of Oncology, Mysore,Gokula Curie Centre Of Oncology, Bangalore,M.S. Ramaiah Memorial & Hospital,Curie Centre of Oncology, Bangalore,Panda Curie Cancer Hospital, Cuttack, Orissa,Curie Manavata Cancer Centre, Nashik, Maharashtra andCurie-Abdur Razzaque Ansari Cancer Institute, Ranchi, Jharkhand.

Based in Bangalore, southern India, Biocon focuses on cancer, diabetes and inflammatory diseases. Biocon has a strong focus in diabetes having launched the world’s first recombinant human insulin, Insugen, using a Pichia based expression system in 2004 and recombinant glargine, Basalog, in 2009.