Updated on 18 December 2012
Bangladesh completes Kala-azar phase III trial
Singapore: PATH's drug development program announced the successful completion of a phase IIIb clinical trial in Bangladesh for the antibiotic Paromomycin intramuscular Injection (PMIM), developed to treat visceral leishmaniasis (VL or kala-azar).
The trial investigated the safety and efficacy of PMIM mono-therapy among 120 patients residing in VL-endemic areas of the country. Findings from this study will support efforts to register PMIM in Bangladesh and ultimately contribute to the national VL elimination strategy.
The trial enrolled its first patient in January 2011, was carried out at two sites through government-run public health centers, and worked with researchers who are experts in the treatment of VL as well as scientists at the Center for Communicable Diseases at icddr,b (an international public health research institution based in Dhaka). By conducting clinical trials at sites that are removed from urban centers, the study also contributed to local capacity-building for research and treatment of this deadly disease.
"Our model for administering PMIM in this study allowed patients to receive testing and treatment in an outpatient setting. This has worked well for those patients who live in rural and remote areas where VL is endemic," said Dr Ponni Subbiah, global program leader for PATH's drug development group. "It is wonderful to know that the drug we developed can contribute to the ongoing efforts to evaluate, strengthen, and expand the arsenal of available treatments for VL."