The Drug Controller General of India has accorded approval for CSIR-OSDD’s proposal (OSDD-TBCT-001) to conduct a Phase IIb clinical trial of a novel combination therapy for MDR TB patients. The trial involves 3 arms, a new combination of PA 824 in a combination of PA 824, Moxifloxacin and Pyrazinamide, a second arm of Pa824 as an add on drug to the current Standard of Care ( DOTS PLUS) and the 3rd arm consisting of the Standard of Care. The new molecule and the novel combination are brought into Clinical Trials in India in collaboration with Global Alliance on Tuberculosis (TB Alliance). The trial is a partnership with National Institute of Tuberculosis and Respiratory Diseases (formerly LRS Hospital), Delhi, an institution under the Ministry of Health which is the Investigator hospital. National Institute for Research in Tuberculosis (formerly TRC), Chennai, an ICMR institute supported the design of the Trails. M/s G V K Biosciences is the Clinical Research Organization supporting the Trials. If the trials (including Phase III) are successful, the drugs will be available at an affordable cost as it will be available for manufacture in India without any royalty to OSDD.
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