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Clinical trials on candidate drug for TB under OSDD to begin soon

Joseph Alexander, New Delhi
Wednesday, December 4, 2013, 08:00 Hrs  [IST]

Putting the search for the first indigenous drug for tuberculosis on an advanced stage, the clinical trial of the candidate drug under the unique model of open source drug discovery (OSDD) programme will start soon.

“The committees have been formed and site has been identified for the clinical trial of the drug. We are waiting for the clearance from the Drug Controller General of India (DCGI) for carrying out the trials,” CSIR director general and the Secretary to the Department of Scientific and Industrial Research Dr Samir K Brahmachair told Pharmbiz.

The trials would take place at the LSR Hospital for Respiratory and Infectious Disease, New Delhi. The phase will involve around 250-300 patients. “We will begin the trials as soon as the approval comes. All other things are in place,” he added.

The drug candidate, PA-824, was synthesised in India long ago. After a series of ownership changes, the molecule was licensed to Council of Scientific and Industrial Research (CSIR) for further development now. OSDD had entered into agreement with Global TB Alliance for developing PA-824 in India.

OSDD is also in discussion with various national and international organizations for the development of some clinical and pre-clinical candidates which includes both new drugs and repurposing drugs for treatment of TB.

Besides completing the trials of TB drug, the OSDD programme will be expanded to cover drug discovery activities to Malaria and Leishmaniasis (Kala-Azar) during the coming years. It would cover open source discovery, open source drug development, open source drug delivery and open source diseases diagnostics in future.

OSDD was launched by Council of Scientific and Industrial Research ( CSIR)  as a new platform for collaborative research and development, especially to address the diseases of the poor as current intellectual property-based models do not entice pharmaceutical companies to venture into such therapeutic areas.

According to estimates, tuberculosis kills hundreds of Indians daily. Almost all TB drugs currently in use were developed in the 1950s and 1960s. The last one was rifampicin in 1966. Isoniazid and pyrazinamide came in 1952 and ethambutol in 1961, as very few pharma companies show interest in the area.

 

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