- No safety issues, no adverse events, reported in initial portion of clinical trial
- All duly contracted sites now actively recruiting to complete Phase I/II patients' enrollment
MONTREAL, Nov. 9, 2022 /CNW/ - ChitogenX Inc., (CSE: CHGX) (OTCQB: CHNXF) ("ChitogenX" or the "Company"), a clinical-stage regenerative medicine company focused on the development of novel regenerative medicine technologies, today announced that it has successfully completed the initial portion of its U.S. Phase I/II ORTHO-R rotator cuff tear repair clinical trial requiring staggered enrolment of 5 patients and Data Safety Monitoring Committee review and sequential clearance for each trial participant.
"Successful completion of the initial safety portion of our U.S. clinical trial is a key milestone for our clinical development program and for the Company. With 9 of the 10 sites now actively recruiting, we look forward to accelerating enrolment of the required remaining patients and reporting the findings of our Phase I/II clinical trial to the FDA", said Philippe Deschamps, CEO. "Our U.S. Phase I/II clinical study is designed to evaluate the safety of, and the role ORTHO-R might play in improving outcomes in rotator cuff tear repair surgeries. Every year, hundreds of thousands of patients undergo rotator tear repair surgery with a significant percentage still experiencing a high failure rate. We believe ORTHO-R to be the ideal biopolymer transport system and scaffold to provide the needed residency for biologics delivered to repair sites to help address this and other high unmet medical need," added Philippe Deschamps.
The staggered recruitment phase of the trial required a waiting period of up to a week after each case to allow the Data Safety Monitoring Committee to evaluate whether there was any need to change the protocol or retard trial progress due to any unforeseen safety issues. We are pleased to report that no such issues arose and recruitment at all approved U.S. clinical sites can now proceed simultaneously.
The U.S. Phase I/II clinical trial is 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 patients at ten clinical sites throughout the U.S. Initial safety phase.
About ChitogenX Inc.
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 RESTORE 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.
Forward-Looking Statements
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.
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SOURCE ChitogenX
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