OneWorld Health Launches Phase 4 Program In India

The Institute for OneWorld Health (iOWH), the US-based non-profit pharmaceutical company that develops drugs for people with infectious diseases in the developing world, has announced the initiation of a major Phase 4 pharmacovigilance and access program of Paromomycin IM Injection for the treatment of visceral leishmaniasis (VL) in India.

Working with the principal investigators who are experts in the treatment of kala-azar, and nongovernmental organization (NGO) partners, OneWorld Health's Phase 4 Program will investigate the safety and efficacy of treatment of VL with Paromomycin IM Injection in progressively more rural areas in Bihar State.

Bihar is the epicenter of the disease in India, with an estimated 250,000 people infected there each year.

The first module of the program will enroll approximately 500 patients to provide additional safety data on Paromomycin IM Injection.

Over the course of the three-year program, up to 1500 additional patients will be included in two subsequent access modules that will extend the network of treatment facilities, providers, and related logistics systems into the most rural areas of Bihar.

This is an innovative access model for administering Paromomycin IM Injection that uses an outpatient setting to diagnose and treat impoverished patients and advanced data transmission technologies in the remote areas where VL is endemic. It is hoped that this access model will be transferable to other infectious diseases in the developing world.

With approximately 500,000 new cases occurring annually, visceral leishmaniasis, also known as kala-azar, is the world's second most deadly parasitic disease, after malaria. VL primarily afflicts rural, resource-poor populations in India, Nepal, Bangladesh, Sudan and Brazil, and affordable therapies are needed.

The Phase 4 Program follows on the success of OneWorld Health's Phase 3 clinical study - the largest VL clinical study performed to date - that established Paromomycin IM Injection as safe, effective, and well-suited to treating VL in impoverished areas.

The Drug Controller General of India (DCGI) approved Paromomycin IM Injection as a treatment for VL on August 31, 2006. The drug was subsequently added to the World Health Organization's Essential Medicines List, and the results of the Phase 3 clinical study were published in the New England Journal of Medicine in June 2007.