Leaders from the U.S. Army Medical Research and Materiel Command product development team for the Paromomycin/Gentamicin topical cream treatment for cutaneous leishmaniasis were recently invited, along with their Tunisian partner from the Institut Pasteur of Tunis, to chair a discussion session at the 3rd workshop in the American Association for the Advancement of Science International Engagement Series, held in Tunis, Tunisia Oct. 31 and Nov. 1.

Maj. Mara Kreishman-Deitrick, product manager at the U.S. Army Medical Materiel Development Activity, Col. Max Grogl, director of the Division of Experimental Therapeutics at the Walter Reed Army Institute of Research, and Professor Afif Ben Salah, head of the Epidemiology Department at the Institut Pasteur of Tunis, will lead a session at the workshop which is part of a series intended to foster a better understanding across the Middle East and North Africa of critical issues associated with international collaboration in the biomedical sciences.

"Recognition of the success of our mutual efforts to develop a new treatment for CL by an organization as prestigious as AAAS is very exciting for us, and highlights the importance of the effort in this region of the world," said Kreishman-Deitrick. "This effort has really showcased the synergy between our two teams and the power of collaborating to achieve a common goal."

The USAMRMC's 10-year collaboration with the Tunisian Ministry of Health, the Institut Pasteur of Tunis and the Institut Pasteur of Paris was selected by AAAS as a success story in a region where such collaborations are often difficult to initiate and sustain.

"This collaboration was sustainable because it was conceived to meet the real needs of the communities involved in the trials," said Ben Salah.

The collaborative effort has led to the completion of three clinical trials evaluating the topical cream for CL, as well as clinical trials for the Army's leishmaniasis diagnostic products, culminating in the completion of a 375-subject pivotal trial of the topical cream this summer.

The U.S.-Tunisian team certainly encountered its share of challenges over the years, many of which are inherent to conducting overseas clinical trials by U.S. Sponsors, but some of which have been unique to Tunisia.

"The Tunisian team, under the leadership of Professor Ben Salah and with the support from the Director of the Institut Pasteur of Tunis, Professor Hechmi Louzir, has done a superb job in finishing a pivotal study with nearly 100% follow-up and zero major deviations despite the hard reality during the start of the recent Tunisian cultural and political revolution," said Grogl.

The collaborative effort has fostered the development of a Tunisian clinical trials team that has set a new standard in the region, and is ready to test future generations of products to combat the problems that continue to impact global health. The data collected on the topical cream will be critical as USAMRMC seeks approval of the product from the U.S. Food and Drug Administration. If approved, a new topical treatment for CL would fill an unmet medical need in the U.S. and throughout endemic areas of the world.