Policy & Regulation
FDA Grants Clearance to Intralytix to Begin Phase I / IIa Clinical Trials
20 February 2018 - - Baltimore, Maryland-based bacteriophage-based products specialist Intralytix, Inc. has received clearance from the Food and Drug Administration to initiate Phase I / IIa clinical trials at Mount Sinai Hospital in New York, New York, the company said.
In July of 2015, Intralytix entered into a collaboration agreement with Saint-Prex, Switzerland-based reproductive medicine and women's health company Ferring Pharmaceuticals to develop a proprietary and well-defined set of bacteriophages specifically designed to treat inflammatory bowel diseases.
The project aims to test the feasibility and efficacy of the bacteriophages in controlled human clinical trials.
Privately-held Intralytix is focused on using its core bacteriophage/phage technology platform to improve human health through the development and commercialization of innovative products for food safety, animal health, human therapeutics, and dietary supplements/probiotics.
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group focused on reproductive medicine and women's health, and in specialty areas within gastroenterology and urology.
The company employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries, and markets its products in 110 countries.
The Mount Sinai Health System encompasses seven hospital campuses, a medical school, and a network of ambulatory practices throughout the greater New York region.
The system includes approximately 7,100 primary and specialty care physicians; 10 joint-venture ambulatory surgery centers; more than 140 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centres.
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