Research On New Treatment For Neglected Disease

Phase 3 research wa published related to its first approved drug product, Paromomycin IM Injection (Paromomycin).

This clinical trial shows that the medicine paromomycin is safe, effective, and well suited to curing visceral leishmaniasis (VL), the world's second most deadly parasitic disease after malaria.

The Institute for OneWorld Health, working closely with the Indian Council for Medical Research (ICMR) sponsored the clinical trial in collaboration with the Special Programme for Research and Training in Tropical Diseases (TDR), a Geneva-based international organization sponsored by UNICEF, UNDP, the World Bank and the World Health Organization. The clinical trial was established with funding from the Bill & Melinda Gates Foundation.

Gland Pharma Limited, the Hyderabad, India-based drug manufacturer, working with OneWorld Health and other collaborators, received regulatory approval from the Drug-Controller General - India (DCGI) for Paromomycin IM Injection as a treatment for VL on August 31, 2006. Gland Pharma has agreed to act as the global manufacturer of Paromomycin to ensure access to all those that need it, and at a markedly reduced cost —currently, approximately $10 USD per 21-day course of therapy.

"The results of this study underscore the potential of Paromomycin to treat VL—and save lives—at very low cost and in safe and practical ways," said Dr. Ahvie Herskowitz, co-founder and chief medical officer of the Institute for OneWorld Health. "This research is essential to increasing access to new therapies for this neglected disease, also known as kala-azar and black fever."

With approximately 500,000 new cases occurring annually worldwide, VL primarily afflicts the rural resource-poor populations in India, Nepal, Bangladesh, Sudan and Brazil, where affordable new therapies are needed.

The print issue of the publication will be available in the June 21, 2007, issue of the NEJM. The article, "Injectable Paromomycin for Visceral Leishmaniasis in India," was authored by Shyam Sundar, M.D., T.K. Jha, M.D., Chandreshwar P. Thakur, M.D., Prabhat K. Sinha, M.D., and Sujit K. Bhattacharya, M.D., Principal Investigators in the Phase 3 clinical trial. The article is accessible online, and can be found at www.nejm.org under the "Current Issue" section of the Web site.

The researchers conducted a randomized, controlled, phase 3 study comparing Paromomycin, an aminoglycoside, and amphotericin B, the present standard of care in Bihar, India. Paromomycin was shown to be noninferior to amphotericin B with a final cure rate of 94.6% vs. 98.8% for amphotericin. Paromomycin also had an acceptable safety profile, which included mild injection-site pain in 55% of patients and transient increases in liver function values in 6% of patients. The NEJM reports that Paromomycin may be advantageous because of the shorter duration of its administration (21 days versus 30 days for amphotericin B), its demonstrated safety and efficacy in pediatric patients (96%) and in patients who failed to be cured with other medicines (98%).

The NEJM article concluded, "The healthcare delivery system in India is well suited to the intramuscular administration of Paromomycin under directly observed therapy, and the local manufacture of Paromomycin in India, potentially at a very low cost, makes this an approachable therapy in the setting of limited resources."

Earlier this year, the World Health Organization (WHO) selected Paromomycin IM Injection for inclusion on its Model List for Essential Medicines. The WHO List of Essential Medicines provides a model for countries to select medicines addressing public health priorities according to quality, safety and efficacy standards.
source:www.emaxhealth.com