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 wo rldwide, 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 heal th priorities according to quality, safety and efficacy standards.
About Visceral Leishmaniasis
VL is a systemic infection caused by various species of Leishmania parasites. The infection is transmitted by sandflies and causes chronic fever, weight loss, splenomegaly, hepatomegaly and anemia. Left untreated, VL is nearly always fatal. VL currently occurs in 62 countries, primarily in the developing world. Of the approximately 500,000 new cases of VL occurring annually, 90% are found in just five countries: India, Bangladesh, Nepal, Sudan and Brazil. South Asia carries 70% of all estimated new VL cases per year worldwide, with India alone carrying 50% of all new cases. The most affected state in India is Bihar, but VL is also endemic in the states of Jharkand, West Bengal, and Uttar Pradesh.
About Paromomycin Phase 3 Clinical Trial
The approval of Paromomycin IM Injection in India is based on data from a large Phase 3 multi-center, randomized, controlled study of 667 adult and pediatric patients conducted in Bihar State, India over a 17-month period from June 2003 until November 2004. Paromomycin was shown to cure 94.6% of patients with VL, with an acceptable side effect profile. The most common adverse reaction among patients treated with Paromomycin was mild pain at the injection site.
About Paromomycin IM Injection
An off-patent aminoglycoside antibiotic, paromomycin is an established drug with an extensive and well-characterized safety profile. Paromomycin IM Injection is now available from Gland Pharmaceuticals (Hyderabad, India) for the first time as a new treatment of VL in India as a once-a-day injection for 21 days. The cost of Paromomycin IM Injection is significantly lower than other currently approved VL therapies.
About the Institute for OneWorld Health
The Institute for OneWorld Health, the first US non-profit pharmaceutical company, develops safe, effective and affordable medicines for people with neglected diseases of the developing world. The Institute for OneWorld Health, headquartered in San Francisco, California, USA, is a tax-exempt 501(c)(3) US corporation. (http://www.oneworldhealth.org/). Media resources are available at http://www.oneworldhealth.org/media/index.php/.