CHITOGENX CONCLUDES ENROLMENT FOR ITS U.S. PHASE I/II ROTATOR CUFF TEAR REPAIR CLINICAL TRIAL
- Study Results to be available Q3-24 after the mandatory post-surgery monitoring
MONTREAL, Sept. 26, 2023 /CNW/ - ChitogenX Inc., (CSE: CHGX) (OTCQB: CHNXF) ("ChitogenX" or the "Company"), a clinical-stage regenerative medicine company, today announced that it has concluded enrolment at 20 subjects in its U.S. multi-site rotator cuff tear repair phase I/II clinical trial entitled: A Blinded, Randomized Controlled Study Investigating the Safety of Ortho-R® for Rotator Cuff Repair Compared with Standard of Care: ORT-2020-01 (Ortho-R® Study).
All study activities will be completed by June 2024 as per the clinical trial protocol following completion of the clinical follow-up and safety analysis for the 20 recruited subjects. Study results are expected during the summer of 2024. ChitogenX is grateful to the sites and subjects for their contribution to this important clinical trial. Thus far, there have been no safety issues reported with every subject having been treated between 3 and 12 months.
"The Company and its clinical and regulatory advisors, believe that concluding subject enrollment at this stage allows for key study objectives to be met. We look forward to demonstrating the safety of our biologic biopolymer ORTHO-R and achieving Phase II readiness at this time next year" said company CEO, Philippe Deschamps. "While completing the follow-up portion of the Phase I/II trial, ChitogenX is now focusing on leveraging the recently announced $4 million development grant as well as securing strategic development partners for other therapeutic indications using its proprietary ORTHO-R regenerative medicine platform", continued Deschamps.
The original U.S. Phase I/II clinical trial protocol was for a blinded, randomized controlled study investigating the safety of ORTHO-R® for rotator cuff tear repair compared with standard of care in a total of 78 subjects at ten clinical sites throughout the U.S. The return on the investment required to complete the full recruitment of the trial is difficult to justify based on the little incremental benefit expected statistically.
ChitogenX Inc. is a clinical stage regenerative medicine company dedicated to the development of novel therapeutic tissue repair technologies to improve tissue healing. The Company is committed to the clinical development of its proprietary ORTHO-R technology platform, a muco-adhesive CHITOSAN based biopolymer matrix, specifically designed to deliver biologics such as platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC), to enhance healing in various Regenerative Medicine Applications.
Other formulations are being developed to leverage the technology's performance characteristics such as tissue adhesion, pliability, and ability to deliver biologics or therapeutics to various tissues damaged by trauma or disease. Further information about ChitogenX is available on the Company's website at www.chitogenx.com and on SEDAR at www.sedar.com.
This news release may contain certain forward-looking statements regarding the Company's expectations for future events. Such expectations are based on certain assumptions that are founded on currently available information. If these assumptions prove incorrect, actual results may differ materially from those contemplated by the forward-looking statements contained in this press release. Factors that could cause actual results to differ include, amongst others, uncertainty as to the final result and other risks. 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, other than as required by security laws.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
SOURCE Ortho Regenerative Technologies Inc.
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