Paris, february 7, 2013
Treatment of Cutaneous Leishmaniasis: Study of Phase III Shows Antibiotic Cream Has High Cure Rate, Few Side Effects
TUNIS – An international research partnership from Tunisia, France and the United States has demonstrated a high cure rate and remarkably few side effects in treating patients with cutaneous leishmaniasis (CL) with an antibiotic cream. CL is a parasitic disease that causes disfiguring lesions and affects 1.5 million people worldwide annually, including the socio-economically disadvantaged in the developing world, especially children. The results of the study conducted by the Institut Pasteur de Tunis, the Institut Pasteur (Paris) and U.S. medical researchers were published today in the New England Journal of Medicine.
“A simple, safe, effective cream has the potential to transform the way CL is treated worldwide.” said Professor Afif Ben Salah, principal investigator for the Tunisia study and head of the Medical Epidemiology Department at the Institut Pasteur de Tunis.
The 375-patient trial was conducted by the Institut Pasteur de Tunis in partnership with the Tunisian Ministry of Health, the Institut Pasteur (Paris) and the U.S. Army Medical Research and Materiel Command (USAMRMC). This cream, named WR 279,396, is a combination of two antibiotics (15% paromomycin-0,5% gentamicin). It cured treated lesions in 81% of patients who participated in the clinical study. Curing the disease was defined as the shrinking of the lesion, regrowth of normal skin and absence of relapse. All adverse events reported were mild or moderate, and were primarily minor skin reactions at the application site.
Current CL treatments include antimonial salts, which contain toxic heavy metals that must be administered either intravenously or injected directly into the lesion. Because of toxicity, many health care providers are hesitant to use them to treat the disease. People who have CL must leave home and work to undergo the standard 20-day course of treatment at a medical center. Public health workers in the developing world see patients resort to home treatments like burning their lesions with battery acid or red-hot machetes, rather than seek out painful and expensive medical treatments. These home remedies can compound the severity of scarring.
“The ease with which this treatment can be administered means that patients could ultimately be able to access care more readily in structures of basic health care and even the school setting,” said Dr. Zaher El Ahmadi, from the Regional Direction of the Tunisian Ministry of Health in Sidi Bouzid, where the patient trial was conducted.
The new antibiotic cream, WR 279,396 has the potential to become a first-line treatment patients could apply themselves.
“CL is not a killing disease, so it’s received very little attention from the research community,” said Professor Hechmi Louzir, Director of the Institut Pasteur de Tunis. “Yet, the effects of CL are lasting. The scarring means many patients face lifelong social stigma at work, school and in social settings, and it is particularly devastating to women and children who are just starting their lives.”
USAMRMC and Institut Pasteur researchers formed a partnership 10 years ago around their common need for better CL treatments. In Tunisia, where the Phase III clinical trial was conducted, up to 10,000 new cases are reported each year and more than half of those cases are in children. The disease also affects immigrants and travelers in Europe.
“These promising results show that we are closer than ever before to putting non-toxic, simple treatments in the hands of patients who need them,” said Pierre Buffet of the Institut Pasteur (Paris) and Pierre & Marie Curie University.
The U.S. Food and Drug Administration (FDA) has designated this new antibiotic cream eligible for fast-track review, given CL’s status as a neglected disease. The Fast Track program of the FDA is a process designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The international research partnership is actively engaged with the FDA to support this review. Additional research also is being planned in Latin America to explore the effectiveness of the topical cream for treating the parasitic species found in the western hemisphere.
About the Institut Pasteur de Tunis
The Pasteur Institute of Tunis (IPT) is a public health research institution under the guardianship of the Tunisian Ministry of Health. It is mandated to carry out all inquiries, missions, analyses and research activities pertaining to human and animal health. IPT produces vaccines and sera for the local need. It contributes to higher education at both the national and regional level and is officially affiliated with the University of Tunis El Manar. IPT is internationally well established and collaborates with several foreign scientific institutions. The Institute is also member of the Institut Pasteur International Network, which consists of 32 institutes throughout the world.
Institut Pasteur Tunis’ (IPT) Leishmaniasis Expertise
Beginning under the leadership of Charles Nicolle (Nobel Prize winner in medicine in 1928), IPT has developed extensive experience with leishmaniasis. Currently it is a World Health Organization (WHO) Collaborating Center for Research and Training on leishmaniasis. Three research laboratories are working on this disease in the areas of epidemiology, immunology and molecular biology within the framework of research projects funded by international agencies. The IPT hosts a Tropical Medicine Resaerch Centre (TMRC) on leishmaniasis funded by US-NIH and holds several licensable patented technologies in the field of leishmaniasis.
About the Institut Pasteur (Paris)
Louis Pasteur created the Institut Pasteur in 1887 as a private non-profit foundation that rapidly became world-renowned for its biomedical research. The main aim of the Institut Pasteur is understanding and preventing diseases throughout the world through excellent scientific and public health research, teaching and other activities. Together with its major contribution to a deeper understanding of fundamental aspects of life, the Institut Pasteur continues to devote a large part of its efforts to infectious diseases, inherited disorders, neurodegenerative diseases and certain cancers. Close to 2,600 people work on its main campus in Paris, which is at the heart of an international network of 32 research institutes on 5 continents. Over the years, 10 Institut Pasteur researchers have received the Nobel Prize.
As the U.S. Army’s medical materiel developer, USAMRMC focuses on medical research, development and acquisition, and medical logistics management. USAMRMC headquarters is located at Fort Detrick, Maryland, and supports 12 subordinate commands and 6 executive agencies located throughout the world.