Contact: Carey Phillips
US Army Medical Research Institute of Infectious Diseases
Fort Detrick, Md. – An international collaboration of researchers from the U.S. Army Medical Research and Materiel Command (USAMRMC), Tunisia and France has demonstrated a high cure rate and remarkably few side effects in treating patients with cutaneous leishmaniasis (CL) with an investigational antibiotic cream. CL is a parasitic disease that causes disfiguring lesions, with 350 million people at risk worldwide and 1.5 million new cases annually, including U.S. military personnel serving abroad and the socio-economically disadvantaged in the developing world, especially children. The results of the research conducted by USAMRMC, the Institut Pasteur de Tunis, the Tunisian Ministry of Health and the Institut Pasteur in Paris were published today in the New England Journal of Medicine.
“A simple cream represents a tremendous breakthrough in the way we treat this neglected disease,” said Maj. Mara Kreishman-Deitrick, product manager at the U.S. Army Medical Materiel Development Activity, which leads the advanced development of medical products for the USAMRMC. “Currently, patients must stay in a medical center for weeks to receive toxic and painful treatments. A cream would offer a safe, effective option that patients can apply themselves.”
Phase III study investigators evaluated WR 279,396, a combination of two antibiotics (15 percent paromomycin-0.5 percent gentamicin). In the trial, the topical cream cured the CL lesions in 81 percent of the patients who participated in the clinical trial. Curing the disease was defined as the shrinking of the lesion, regrowth of normal skin and absence of relapse. Adverse events were reported in less than 5 percent of all study groups and were primarily reported as minor reactions at the application site.
A cream containing paromomycin alone (15 percent paromomycin) had a similar cure rate of 82 percent. In the study, only 58 percent of the patients who received a vehicle cream not including antibiotics or other active ingredients saw the lesions cured.
Researchers said they expected parity between the single and combination therapies in this study, which treated CL caused by L. major, a parasitic species common in the Middle East and North Africa.