Tunisian Officials Visit USAMRMC

Fort Detrick, Md. – May 23-27: The U.S. Army Medical Materiel Development Activity hosted a delegation of five officials from the Tunisian Ministry of Public Health and the Institute Pasteur of Tunis for a visit to the U.S. Army Medical Research and Materiel Command as part of a long-standing collaboration for the development of the Paromomycin/Gentamicin Topical Cream for the treatment of cutaneous leishmaniasis.

In addition to a meeting with the USAMRMC principal assistant for Acquisition, Dr. Kenneth Bertram, the delegates visited USAMMDA and the Walter Reed Army Institute of Research, both of which have been crucial partners over the course of the product development effort. According to Col. Russell Coleman, commander of USAMMDA, the meeting with the Tunisian delegates was extremely productive.

"In addition to discussing the many accomplishments of the past, the joint U.S. and Tunisian team addressed a number of upcoming issues that will be critical to the ultimate success of our collaborative effort, the fielding of a FDA-approved topical treatment for cutaneous leishmaniasis," said Coleman. "While past discussions have focused on the clinical trials needed to demonstrate that topical paromomycin is safe and effective, our current meeting primarily focused on the manufacturing and commercialization of the product so that it will be available to meet the needs of individuals throughout the world who are afflicted with cutaneous leishmaniasis."

Cutaneous leishmaniasis is a disease that affects over one million people a year worldwide, with nearly 3,000 U.S. Servicemembers infected since 2003. If left untreated, cutaneous leishmaniasis results in disfiguring scars, and occasionally it can progress to the much more serious mucocutaneous and visceral forms of leishmaniasis.

Because there is no topical treatment currently approved by the U.S. FDA, U.S. Servicemembers have to be evacuated from the theater of operations to be treated with expensive and often toxic intravenous therapies. An approved topical treatment would allow physicians to prescribe Servicemembers with Paromomycin/Gentamicin Topical Cream to treat that will allow them to treat their own cutaneous leishmaniasis in theater and return to duty quickly.

"From the beginning the Tunisians understood we were fighting a common enemy, cutaneous leishmaniasis," said Col. Max Grogl, director of the Division of Experimental Therapeutics at WRAIR. "Access to endemic areas is fundamental to the conduct of pivotal trials that comply with current Good Clinical Practices."

People living in cutaneous leishmaniasis-endemic areas throughout the world are also eagerly awaiting the availability of a safe and effective topical treatment. The population of Tunisia is significantly affected by cutaneous leishmaniasis, with approximately 2,000 to 3,000 cases per year. This puts a tremendous strain on the resources of the Tunisian health system. The current standard of care for cutaneous leishmaniasis in Tunisia is intralesional injections of the toxic antimonial compound Glucantime. This treatment is especially painful in children who are predominantly affected by the disease.

The nearly 10-year collaboration between the USAMRMC, the Institute Pasteur of Tunis and the Tunisian Ministry of Health has resulted in the successful conduct of three clinical trials of the Paromomycin/Gentamicin cream in Tunisia: two Phase 2 trials, and an ongoing Phase 3 pivotal efficacy trial. Data from the Phase 3 trial, scheduled to be completed later this summer, will be an absolutely critical part of the clinical data package that will be submitted to the FDA for approval of this product.

"The most important impact a long-term collaboration has on clinical trials is the total integration of the members of the American and Tunisian teams," said Grogl. "Total trust and respect is a great gift and is a sign of a mature and healthy collaboration. This was a fantastic opportunity to work in probably the most neglected of the neglected diseases."

"Good health is a wonderful gift, appreciated by all peoples," said Grogl.

According to Grogl, the Army is in a great position to use the topical treatment to reduce the burden of cutaneous leishmaniasis across North African, Central-Western Asian and South American leish-endemic countries.

The Phase 3 trial has taken on particular significance this year, amid the current political unrest in Tunisia. The Tunisian revolution began in the town of Sidi Bouzid, which is also the location of the central clinic for the Phase 3 trial.

The Tunisian study team has gone to great lengths to ensure the study continued uninterrupted, without jeopardizing the safety and welfare of the study subjects or the quality of the study results.

By Maj. Mara Kreishman-Dietrick, USAMMDA product manager for Pharmaceutical Systems Project Management Office