Drug developer Atox Bio announced today that the US Food and Drug Administration (FDA) has granted fast track designation to AB103, its lead product, currently in development for the treatment of Necrotizing Soft Tissue Infections (NSTI).
Atox Bio has completed recruitment of 40 patients in a Phase II proof of concept study evaluating AB103’s clinical benefit when administered as well as its standard of care. The company said that efficacy data from these 40 patients is expected by the end of 2012.
NSTI includes several distinctive clinical diagnoses that share clinical features representing the most severe types of infections involving the skin, skin structure and soft tissue with a high mortality rate. Currently, there are no approved treatments for NSTI. The existing principles of NSTI management include early diagnosis with prompt and repeated surgical debridement, aggressive resuscitation and physiologic support, in addition to antimicrobial drugs. As neither surgical debridement nor antibacterial therapy directly address the immunological pathogenesis of NSTI, modulating the host inflammatory response could lead to important clinical benefits in morbidity and mortality.
University of Washington Harborview Medical Center Professor of Surgery and Chief of Trauma Dr. Eileen Bulger said, “Patients with necrotizing soft tissue infections have a devastating disease with a high risk of death. Those who survive require multiple surgeries and many require amputations. We are excited to explore new treatment options to help manage these critically ill patients. It is our hope that AB103 will be a valuable adjunct in the management of this disease."
Atox Bio CEO Dan Teleman said, "The Fast Track designation recognizes the significant unmet need that exists in the treatment of NSTI and the important role that AB103 can play in treating these patients. This is a major milestone for Atox Bio that comes after the FDA has granted AB103 Orphan Drug designation in October 2011. We look forward to working closely with the FDA to bring to market as quickly as possible what could be the first agent to help NSTI patients."
Atox Bio was founded in 2003 by Prof. Raymond Kaempfer and Dr. Gila Arad from the Hebrew University of Jerusalem Faculty of Medicine, and Yissum, the technology transfer company of the Hebrew University of Jerusalem.
Published by Globes [online], Israel business news - www.globes-online.com - on September 10, 2012
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