PRESS RELEASE
FOR IMMEDIATE DISCLOSURE
CHITOGENX is completing recruitment for its study
AMERICAN PHASE I/II CLINIC FOR REPAIR OF
ROTATOR CAP TEARS
- The results of the study will be available at T3-24 after mandatory postoperative monitoring
Montreal, Quebec, September 26, 2023 – ChitogenX (CSE: CHGX, OTCQB: CHNXF) (“ChitogenX” or the ” Pursue “), a clinical-stage regenerative medicine company, today announced that it has completed enrollment of 20 subjects for its multi-site Phase I/II clinical trial in the United States to repair cuff tears. Rotator with the Title: A Blinded, Randomized Controlled Trial of the Safety of Ortho-R® for Rotator Cuff Repair Compared to Standard Treatment: ORT-2020-01 (Ortho-R Study ®).
All study activities will be completed according to the clinical study protocol by June 2024, after clinical monitoring and safety analysis is completed for all 20 enrolled subjects. Study results are expected in summer 2024. ChitogenX thanks the sites and subjects for their contribution to this important clinical study. To date, no safety concerns have been reported as each subject was treated for between 3 and 12 months.
- The Company and its clinical and regulatory advisors believe that the conclusion of the
Recruitment of subjects in this phase contributes to achieving the main objectives of the study. We look forward to demonstrating the safety of our ORTHO-R biopolymer and being ready for Phase II by this time next year,” said Philippe
Deschamps, CEO of the company. “During the completion of the part followed
In the Phase I/II study, ChitogenX is now focused on leveraging the recently announced $4 million development grant and seeking strategic development partners for additional therapeutic indications using its platform. form of regenerative medicine ORTHO-R,” continued Mr. Deschamps.
The original U.S. Phase I/II clinical trial protocol was a randomized, controlled, blinded trial to evaluate the safety of ORTHO-R® for rotator cuff tear repair compared to usual care in a total of 78 subjects across ten clinical sites in the United States. The return on investment required to complete full study recruitment is difficult to justify given the small additional benefit expected from a statistical perspective.
About ChitogenX Inc.
ChitogenX Inc. is a clinical-stage regenerative medicine company focused on developing novel tissue repair therapeutic technologies to enhance tissue healing. The Company is engaged in the clinical development of its proprietary ORTHO-R technology platform, a CHITOSAN-based mucoadhesive biopolymer matrix specifically designed to improve the delivery of biologics such as platelet-rich plasma (PRP) or concentrated bone marrow aspirate (BMAC) for healing in various healing Applications of regenerative medicine.
Other formulations are being developed to take advantage of the technology’s performance characteristics, such as: B. Tissue adhesion, flexibility, and the ability to deliver biologics or therapeutics to various tissues damaged by trauma or disease. Additional information about ChitogenX can be found on the Company’s website at www.chitogenx.com and on SEDAR at www.sedar.com
Forward-Looking Statements
This press release may contain certain forward-looking statements about the Company’s expectations regarding future events. These statements are “forward-looking” because they are based on our current expectations regarding the markets in which we operate and various assumptions and estimates. Actual facts and results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business or if our estimates or assumptions prove incorrect. The Company disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by securities laws.
NEITHER THE CANADIAN SECURITIES EXCHANGE OR ITS REGULATORY SERVICE PROVIDERS HAVE REVIEWED OR ACCEPT ANY RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS PUBLICATION.
For further information please contact:
Philippe Deschamps,
President and CEO
614-596-2597
deschamps@chitogenx.com
Or
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