The Institute for OneWorld Health, a US-based non-profit pharmaceutical company that develops drugs for people with neglected diseases in the developing world, today announced the selection of Odyssey Research, a Bismarck, North Dakota-based clinical trial management organization (TMO) with offices in New Delhi, India, to support its upcoming Phase 4 pharmacovigilance and access study of Paromomycin Intramuscular (IM) Injection for the treatment of visceral leishmaniasis (VL) in India.
With approximately 500,000 new cases occurring annually, visceral leishmaniasis, also known as kala-azar or black fever, is the world?s second most deadly parasitic disease following malaria.
“We welcome Odyssey Research as part of our team to further develop Paromomycin IM Injection as a safe, affordable and effective treatment for a major public health problem in India,” said Dr. Ahvie Herskowitz, OneWorld Health?s Chief Medical Officer. “Odyssey?s clinical trial management capabilities and depth of experience in India make them a good fit for this important post-approval Phase 4 study.”
Odyssey Research will perform regular monitoring of seven clinical sites for the pharmacovigilance module in the Phase 4 study. The study, scheduled to begin later this year, will be conducted in the state of Bihar, India.
The first module will enroll 500 patients in a pharmacovigilance study to confirm the safety and efficacy of Paromomycin IM Injection in an outpatient setting. Over the next three years, up to an additional 1500 patients will be included in two subsequent access modules that will monitor the effectiveness of a progressively extending network of treatment facilities and related logistics systems throughout rural Bihar. The results of the Phase 4 study are intended to provide a model for administering Paromomycin IM Injection safely and effectively in an outpatient setting in remote areas where the disease is endemic.
“We are honored to be working with OneWorld Health as their TMO for this Phase 4 study,” said Dr. Mubarak Naqvi, Odyssey?s Regional Director. “This is an important project that will take our team to some of the remotest areas of Bihar. We look forward to taking up this unique challenge and contributing productively towards the success of this study,” he continued.
Gland Pharma Limited, the Hyderabad, India -based drug manufacturer, working in collaboration with OneWorld Health, received regulatory approval from the Drug-Controller General – India (DCGI) for Paromomycin IM Injection as a treatment for VL on August 31, 2006.