Biocon India has developed India's first fermentation-derived immuno-suppressant life saving drug – 'Mycophenolatemofetil' for organ transplantation using a state-of-the-art novel fermentation technology –Plafractor, now plans to conduct limited clinical trials to investigate the novel indication.
This will be the first trial to be conducted and will be carried out by a group of Bangalore based medical investigators. The trial results are expected to be generated over a period of 9-12 months, based on which further extensive trials will be planned, informed Kiran Mazumdar-Shaw, chairman and managing director, Biocon India Group.
At a scientific symposium titled “Potential uses of Mycophenolatemofetil in renal diseases”, sponsored by Biocon India, Dr. Anthony Allison, the inventor of a billion dollar molecule, Mycophenolatemofetil, and a member of the Scientific Advisory Board, Biocon India Group explained the potential use of the molecule for the treatment of diabetic nephropathy.
“Mycophenolate is widely used as an immuno-suppressant in organ transplantation and is gaining acceptance because of its low cytotoxic profile as compared to other conventional immuno suppressants such as cyclosporin. Recent research has revealed the benefits effects of Mycophenolatemofetil with anti-inflammatory effects on renal endothelial linings resulting in the reversal of renal malfunction on animal models. Being a well characterized drug with a good safety profile, it is believed that it can have beneficial indications on diabetic nephropathy which affects 30 per cent of diabetics. Currently, diabetic nephropathy is treated with ACE inhibitors with moderate control on disease progression. It is hoped that Mycophenolate either on its own or in conjunction with ACE inhibitors could greatly retard disease progression,” said Dr. Anthony Allison.
Dr. Prasanna Kumar, professor & head, department of endocrinology & metabolism, M S Ramaiah Hospital, who chaired the symposium emphasized the importance of this trial in addressing a critical unmet medical need. ACE inhibitors had their limitations, he said, and if MMF could demonstrate enhanced efficacy, it would benefit a large number of diabetics who fear the dreaded progression into renal malfunction.
Dr. Urmila Anand, assistant professor & head, department of nephrology, St. John's Medical College, who co-chaired the session, expressed keen interest to enhance medical wisdom through such research efforts, which could address diabetic nephropathy and also demonstrate that quality clinical trials can be conducted in India.
Clinigene, a subsidiary of Biocon India Group headed by Dr Arvind Atignal, is focused on clinical research in diabetes and acknowledged to have the best characterized 'diabetic registry' in the country.
Biocon is keenly focused on diabetes both in terms of research and products. Biocon expects to launch its Recombinant Human Insulin by the end of this year.