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Advinus Therapeutics seeks DCGI approval to conduct clinical trials

Advinus Therapeutics seeks DCGI approval to conduct clinical trials
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First Published: Thu, Jun 18 2009. 12 47 AM IST

New drug: Rashmi Barbhaiya, managing director and CEO, Advinus.
New drug: Rashmi Barbhaiya, managing director and CEO, Advinus.
Updated: Thu, Jun 18 2009. 12 47 AM IST
Mumbai: The Tata group’s drug discovery firm, Advinus Therapeutics Pvt. Ltd, has sought regulatory approval to conduct clinical trials of its first drug molecule aimed at treating type-2 diabetes.
“We have applied to the Drug Controller General of India (DCGI) for the phase I trials and expect to start the trials in three months depending on the regulatory approval,” managing director and chief executive Rashmi Barbhaiya said over phone.
New drug: Rashmi Barbhaiya, managing director and CEO, Advinus.
Phase I trials are the first stage of testing a new drug candidate on humans—usually a small group of 20-30 healthy volunteers—mainly for safety and tolerance.
Diabetes is one of the fastest growing reported diseases, especially in India, due to lifestyle changes and hereditary reasons. As the market for anti-diabetes drugs grows phenomenally, at least 50 research firms across the world are working to develop new medicines.
“We would also like to partner with a global company to take forward the molecule to the advanced stage of development for the international market once the proof of concept is established after the phase I and II trials, though the phase I study is currently planned only in India,” Barbhaiya said.
Advinus, India’s first dedicated drug research company, on Wednesday opened its second drug discovery facility in Pune.
The company already has one research centre each in Bangalore and Pune, with a combined staff of 470. The new centre, set up at an investment of Rs70 crore, will have 120 people initially, Barbhaiya said.
Advinus is working with two multinational drug companies to develop drugs for other diseases.
The company had in 2006 signed a collaborative research project with US drug maker Merck and Co. Inc. to develop drugs to fight metabolic disorders.
In 2008, the company announced a research collaboration with the world’s third largest biotechnology company, Genzyme Corp., and Medicines for Malaria Venture (MMV) to develop therapies that would address the emerging resistance to anti-malarial treatments.
MMV, an affiliate of the World Health Organization, was formed to identify and support promising research projects to develop new therapies for malaria.
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First Published: Thu, Jun 18 2009. 12 47 AM IST