In a global effort to treat Leishmaniasis, the U.S. Department of Defense signed a Cooperative Test and Evaluation Project Agreement with the French Republic Minister of Defense to further the development of Topical Paromomycin + Gentamicin Cream, a new drug being developed by the U.S. Army for the treatment of simple and non-complicated cutaneous leishmaniasis.
Cutaneous leishmaniasis is a neglected disease of military significance and a major public health challenge in the Middle East, Mediterranean basin, and Latin America. According to the World Health Organization, leishmaniasis is endemic in 88 countries and the population at risk is more than 350 million. The disease is a vector-borne protozoal infection of the skin and mucosal tissues, and infection can result in chronic and sometimes disfiguring necrotic lesions.
"The signing of this project agreement marks a significant achievement that involved the dedicated efforts of numerous individuals over a two year period," said Lt. Col. Karen M. Kopydlowski, product manager for Topical Paromomycin at the U.S. Army Medical Materiel Development Activity.
The agreement was spearheaded November 2006 by Lt. Col Philip L. Smith, former product manager; Col. Max Grögl, scientific lead at Walter Reed Army Institute of Research; Patricia J. Showe and Judy Williams in the International Affairs Office at the U.S. Army Medical Research and Materiel Command; and Col. Bruno Sicard, French Military Liaison Officer at USAMRMC.
The U.S. and French militaries require a safe and simple treatment for cutaneous leishmaniasis as there is no prophylactic pharmaceutical or vaccine available, and there are no FDA approved therapeutic drugs for cutaneous leishmaniasis. Currently, available treatment options include the use of intravenous Sodium Stibogluconate, a drug that has been used since 1912 as an investigational drug, and whose active ingredient is based on the metal antimony. The other option is Amphotericin B which is not FDA-approved for treating cutaneous leishmaniasis.
As part of this new agreement, the U.S. will provide the drug to the French military in order to sponsor and conduct clinical trials with "Topical Paromomycin + Gentamicin Cream" in French Guiana. The U.S. and French will share medical information and results from the clinical trials.
Key parties in this agreement include the U.S. Army Medical Research & Materiel Command; U.S. Army Medical Materiel Development Activity; Walter Reed Army Institute Research; the Office of the Deputy Assistant Secretary of the Army for Defense Exports and Cooperation; the Direction Centrale du Service de Santé des Armées, the Pharmacie Centrale des Armées, the Institut de Médecine Topicale du Service Santé Armées; and the Hôpital d'Instruction des Armées Laveran.