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Army Moves Forward on Topical Drug for Cutaneous Leishmaniasis

The U.S. Army Medical Material Development Activity (USAMMDA) yesterday announced its intent to award a sole source contract to Fast Track Drugs and Biologics to assist USAMMDA’s drug development and approval efforts for a topical to treat Cutaneous Leishmaniasis.

USAMMDA has for several years been working on a Topical Paromomycin Cream for self-treatment of Cutaneous Leishmaniasis, a serious parasitic disease caused by protozoan parasites. It is transmitted to humans through the bite of an infected sand fly in tropical and subtropical zones, including the Middle East. Although Leishmaniasis is usually a non-life threatening disease, it can be mutilating and disfiguring.

Current traditional treatments for Leishmaniasis require intravenous or intralesional administration of toxic, heavy metal-based drugs (antimonials). In the United States, this is an investigational treatment that involves 10-20 days of daily IV infusions under close physician monitoring in a hospital. This treatment course involves many side effects and toxicities, including vomiting, diarrhea, pancreatitis, elevated liver enzymes, and potentially pulmonary edema at higher doses.

From 2003 to present, more than 1,100 U.S. servicemembers have required such treatment for Leishmaniasis. In addition to the unwanted side effects, the disease therapy is expensive and requires troops to be evacuated from their units and brought to the U.S. for treatment.

The World Health Organization (WHO) has endorsed treatment with topical paromomycin formulations as first-line therapy for Cutaneous Leishmaniasis, and the USAMMDA Topical Paromomycin product is poised to be the first such solution for the broader worldwide community.

Topical Paromomycin’s United States and International development partners include: USAMMDA; Walter Reed Army Institute of Research (WRAIR); the Institut Pasteur de Tunis, the Institut Pasteur – Paris; the Gorgas Memorial Institute for Health Studies – Panama City, Panama; the Universidad Peruana Cayetano Heredia – Lima, Peru; Naval Medical Research Detachment – Peru; and the Walter Reed National Military Medical Center (WRNMMC).

U.S. Army Medical Research Acquisition Activity (USAMRAA) is managing the contract under Solicitation Number: W806YH21816001.

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