Therapy for diabetic nephropathy

AT A recent symposium in Bangalore , Dr. Anthony Allison, the inventor of a billion dollar molecule, Mycophenolate mofetil (MMF), expounded on its potential use for the treatment of Diabetic Nephropathy.

At present, MMF is very widely used as an immunosuppressant in the organ transplantation process and is gaining rapid acceptance on account of its low cytotoxic profile as compared to other conventional immunosuppressants such as cyclosporin. Besides, MMF is cheaper than cyclosporin.

Dr. Allison is a world renowned scientist, who graduated form Oxford & was Consultant Pathologist at Medical Research council, Northiwick Park Hospital in London before moving to Syntex, where he was involved in the invention of MMF & several other compounds such as Neproxin. Currently he is at Surromed at Palo Alto involved in biomarker research in diabetes and other diseases.

According to Dr. Allison , recent research work has revealed beneficial effects of MMF with anti-inflammatory effects on renal endothelial linings resulting in the reversal of renal malfunction on animal models. Being a well-characterised drug with a very good safety profile, it is believed that it can have beneficial indications on diabetic nephropathy which affects 30 per cent of diabetics.

Presently, Diabetic Nephropathy is treated with ACE (Angiotensin Converting Enzyme) inhibitors which are generally used to treat blood pressure.

High pressure of Glomeruli in the kidneys is felt to be one of the causes of renal failure and ACE inhibitors reduce this pressure. It is hoped that MMF either on its own or in conjunction with ACE inhibitors could greatly retard disease progression.

The Bangalore-based Biocon India, which has developed a novel process for MMF and is the only manufacturer of this fermentation derived drug in India , intends to conduct limited clinical trials to investigate this new application . The clinical trials will be the first ever in the world for this application of MMF and will be conducted by Clinigene , a company belonging to the Biocon Group.

Dr. Allison, who is on the Scientific Advisory Board of Biocon, is impressed by the quality of clinical capabilities at Clinigene, a Biocon subsidiary, that is focused on clinical research in Diabetes. Clinigene is acknowledged to have the best characterized Diabetic Registry in the country.

According to Dr. Kiran Mazumdar Shaw of Biocon , Clinigene will conduct human trials on approx. 30 patients as a pilot study.

Trial results are expected to be generated over a period of approximately 9-12 months. If the results are positive , multicentric full fledged trials on at least 150 patients are planned . The full blown trials will cover both types of diabetics.

According to Dr. Prasanna Kumar, Professor & Head department of Endocrinology & Metabolism, M S Ramaiah Hospital, ACE inhibitors have their limitations and if MMF could demonstrate enhanced efficacy, it would prove a huge benefit to the large number of diabetics who fear the dreaded progression into renal malfunction.

N. N. Sachitanand

in Bangalore

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