ChitogenX Inc (CSE:CHGX, OTCQB:CHNXF) announced that it has successfully completed the initial portion of its US Phase I/II ORTHO-R rotator cuff tear repair clinical trial requiring staggered enrolment of five patients and Data Safety Monitoring Committee review and sequential clearance for each trial participant.
The Montreal-based clinical-stage regenerative medicine company said 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.
ChitogenX reported that “no such issues arose” and recruitment at all approved US clinical sites can now proceed simultaneously.
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"Successful completion of the initial safety portion of our US clinical trial is a key milestone for our clinical development program. 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 US Food and Drug Administration (FDA)," ChitogenX CEO Philippe Deschamps said in a statement.
"Our US 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 needs.”
The US Phase I/II clinical trial is a blinded, randomized controlled study investigating the safety of ORTHO-R for rotator cuff tear repair compared with the standard of care in a total of 78 patients at 10 clinical sites throughout America during the initial safety phase.
ChitogenX is working on the clinical development of its RESTORE technology platform, a mucoadhesive chitosan-based biopolymer matrix, designed to deliver biologics such as platelet-rich plasma or bone marrow aspirate concentrate (BMAC), to help to heal in musculoskeletal conditions. ORTHO-R, the firm’s lead chitosan- platelet-rich plasma (PRP) hybrid biologic implant combo product, is aimed at increasing the healing rates of sports-related injuries to tendons, ligaments, and cartilage such as the meniscus.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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