Intralytix Receives FDA clearance to initiate Phase I / IIa clinical trials
Baltimore, Maryland, U.S.A. - February 15, 2018 - Intralytix, Inc. announced today that it received clearance from the Food and Drug Administration (FDA) to initiate Phase I / IIa clinical trials at Mount Sinai hospital in New York, NY.
In July of 2015, Intralytix entered into a collaboration agreement with Ferring Pharmaceuticals to develop a proprietary and well-defined set of bacteriophages specifically designed to treat inflammatory bowel diseases (IBD). The project aimed to test the feasibility and efficacy of the bacteriophages in controlled human clinical trials.
Dr. Alexander Sulakvelidze, Executive Vice President and Chief Scientific Officer of Intralytix commented: "This is a major milestone in the history of our company, and in the phage therapy field in general. This is one of the first full-blown INDs approved for phages by the FDA, and the first ever IND approved for targeting adhesive invasive E. coli (AIEC) in patients. This approval paves the way for an important clinical study, and also shows that Intralytix continues to demonstrate our leadership in successfully obtaining regulatory approvals and commercializing various bacteriophage products."
Dr. Per Falk, Executive Vice President for R&D and Chief Science Officer of Ferring Pharmaceuticals, added "Bacteriophages offer a unique tool to gently fine-tune the gut microbiota by specifically targeting problem-causing bacteria. We are excited with the progress made by our partner Intralytix in obtaining IND approval for the phage preparation that targets AIEC - a pathogen increasingly implicated in the pathogenesis of Crohn's disease. We look forward to Intralytix initiating clinical trials with our colleagues at Mount Sinai hospital, to evaluate the safety and efficacy of this proprietary bacteriophage preparation in human volunteers."
Dr. Jean-Frederic Colombel, MD, Professor of Medicine (Gastroenterology) at the Icahn School of Medicine at Mount Sinai and Director of the Leona M. and Harry B. Helmsley Charitable Trust Inflammatory Bowel Disease Center at the Mount Sinai Medical Center, will serve as the Principal Investigator of this clinical trial. Dr. Colombel commented: "AIEC have been implicated in the pathogenesis of Crohn's disease. Bacteriophages may offer a much-needed approach for specifically targeting AIEC in the human gastrointestinal tract thereby reducing the risk of progression of Crohn's disease. If the approach shows efficacy in the planned clinical trials in our hospital, it will enhance and expedite product development and could ultimately benefit hundreds of thousands of people suffering from Crohn's disease."
About Intralytix Inc.:
Intralytix, Inc. is a privately-held company headquartered in Baltimore, Maryland. The Company 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.
Intralytix is the first company in the world to receive FDA-approval for a phage-based product for food safety applications. The Company currently has the world's largest portfolio of FDA-approved phage-based products on commercial markets. It holds several bacteriophage technology-related patents, including two U.S. patents (and additional patents pending) on the use of bacteriophages for fine tuning human or animal microbiome by using phages to reduce or eliminate bacterial colonization (US 7,459,272 B2 and US 8,003,323 B2). To learn more about Intralytix, Inc. or its products please visit www.intralytix.com.
About Ferring Pharmaceuticals:
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and women's health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company's research and development investment goes towards finding innovative and personalized healthcare solutions to help mothers and babies, from conception to birth. Founded in 1950, Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries, and markets its products in 110 countries. Learn more at www.ferring.com and @Ferring, or connect with us on Facebook, Instagram and LinkedIn.
About the Mount Sinai Health System:
The Mount Sinai Health System is New York City's largest integrated delivery system encompassing seven hospital campuses, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai's vision is to produce the safest care, the highest quality, the highest satisfaction, the best access and the best value of any health system in the nation. 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 centers. Physicians are affiliated with the renowned Icahn School of Medicine at Mount Sinai, which is ranked among the highest in the nation in National Institutes of Health funding per investigator. The Mount Sinai Hospital is ranked No. 18 on U.S. News & World Report's "Honor Roll" of top U.S. hospitals; it is one of the nation's top 20 hospitals in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Geriatrics, Nephrology, and Neurology/Neurosurgery, and in the top 50 in four other specialties in the 2017-2018 "Best Hospitals" issue. Mount Sinai's Kravis Children's Hospital also is ranked in six out of ten pediatric specialties by U.S. News & World Report. The New York Eye and Ear Infirmary of Mount Sinai is ranked 12th nationally for Ophthalmology and 50th for Ear, Nose, and Throat, while Mount Sinai Beth Israel, Mount Sinai St. Luke's and Mount Sinai West are ranked regionally. For more information, visit http://www.mountsinai.org/, or find Mount Sinai on Facebook, Twitter and YouTube.
Feb 15, 2018