Kala-azar treatment completes phase 3(b) clinical trial in Bangladesh

Contact:
Elena Pantjushenko, 650.392.2537, epantjushenko@path.org.

South San Francisco, California, December 17, 2012—PATH’s Drug Development program announced today the successful completion of a phase 3(b) 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 Centre 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.” 

Visceral leishmaniasis (VL or kala-azar), is a neglected and deadly infectious disease that is transmitted through the bite of a sand fly. It affects the visceral organs, causing chronic fever, weight loss, and anemia. If left untreated, VL is nearly always fatal, especially in children. VL is endemic in 79 countries, primarily in low-resource settings. The population at risk is estimated at 200 million; 20 to 40 thousand people are estimated to die from VL each year.

Paromomycin, an off-patent aminoglycoside antibiotic, is an established drug with an extensive history of use and a well-characterized safety profile. OneWorld Health developed PMIM as an effective, inexpensive, and safe treatment for VL and worked with leading clinical researchers and the Indian pharmaceutical company Gland Pharma to manufacture the treatment. The cost of a course of treatment with PMIM as a mono-therapy for 21 days is less than US$20, which is significantly lower than other currently approved VL therapies. PMIM is recommended by the World Health Organization as a preferred combination therapy to treat VL in South Asia. PMIM is also registered with the drug regulatory agencies of India, Nepal, and Uganda. A number of studies are evaluating PMIM for use in combination with other treatments as a key tool in global VL elimination strategy.

PATH’s Drug Development global program was established through its affiliation with OneWorld Health, a nonprofit drug development organization. The program works to develop and ensure the availability and accessibility of safe and effective new medicines for diseases disproportionately affecting people in developing countries. For more information, please visit our Drug Development program website.