Torrent Pharmaceuticals Ltd which discovered and patented the AGE (Advanced Glycosylation End-products) has successfully completed its phase-I trials leveraging the best of international and Indian expertise. Now the drug is ready for phase-II trials with Ecron Acunoav India.

The AGE compound holds potential in the treatment of heart disease and diabetes related vascular complications. The proprietary molecule has the potential of a blockbuster in the offing, said Dr Vijay Chauthaiwale, vice-president, Torrent Research Centre.

The company's clinical development programme has made the best use of both global and Indian expertise. In this regard, it opted for Veeda Clinical Research which has offices both at Plymouth, UK and Ahmedabad. This has helped the company to outsource toxicology studies and first in man studies from Plymouth because of the expertise in novel diagnostic methods there to detect heart disease at an early stage. After the initial results that proved positive towards the drug, the multiple ascending dose was done on patients in India. With no major queries from the regulators, MHRA, UK and Drugs Controller General of India, the phase-I results are to be published in a couple of months and efforts to proceed to phase-II are on.

"In phase-II we have opted for Ecron Acunova India. The study is an even bigger challenge for the company. We need to incorporate biomarkers and ensure the integration of pre-clinical and phase-I studies," said Dr Chauthaiwale, who was here in Bangalore in connection with the Bangalore Bio 2009.

Discussing at length on the critical issues of early clinical development in the country, he said that companies are reluctant to conduct early phase-II here but are comfortable to carry out the late phase-II and III studies. India is good in site management and patient recruitment but has no experience in protocol development. This is where an Indian CRO with a global presence is preferred by pharma companies to provide the best of clinical expertise and project management.

While India is a major hub for clinical trials most of these trials are part of the global clinical development programme. The country's CROs lack the skills of early clinical development especially in translational research and proof-of- concept studies. On the other hand, the clinical trials in Western countries have low recruitment rate and expensive. In order to overcome these constraints, Torrent chalked out its innovative collaboration model with an objective to devise a clinical development programme of global standards while leveraging the Indian advantage only to have a win-win situation for both sponsor and CRO, he said.

Torrent's other clinical development projects include the DPP-IV inhibitors, which is a new class of anti diabetic drugs that is in the preclinical stage and expected to enter phase-1 trials soon. A diabetes-related R&D project, which is on PTP-1b inhibitors is also a novel- approach in anti-diabetic therapy is in the lead identification stage, stated Dr Chauthaiwale.