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FDA Clears First Clinical Study for a Polymicrobial Phage Library-Based Treatment for Antibiotic-Resistant Infections | Business Wire

By March 16, 2020No Comments
Adaptive Phage Therapeutics A New World of Treatment

Adaptive Phage Therapeutics A New World of Treatment GAITHERSBURG, Md.–(BUSINESS WIRE)–Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the clinical development of PhageBank™, a personalized bacteriophage therapeutic for the treatment of MDR and complicated bacterial infections. The Phase 1/2 trial represents the first study of an expanding phage library under FDA allowance for a multi-site study of intravenous administration and/or bladder instillation of phage therapy. Beginning in Q2, APT will enroll patients at up to three clinical sites for the evaluation of PhageBank for the treatment of complicated and chronic recurrent urinary tract infections (UTIs).

 

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