ChitogenX Inc (CSE:CHGX, OTCQB:CHNXF) said it has concluded the enrolment of 20 subjects in its US 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)'.
The company's shares rose 8.3% to C$0.13 by noon in Toronto.
As per the clinical trial protocol, the company said all study activities will be completed by June 2024 after it has completed the clinical follow-up and safety analysis for the 20 recruited subjects. The results of the study are expected during the summer of 2024, it added.
ChitogenX noted there have been no safety issues reported so far, with every subject having been treated for between three and 12 months.
“We look forward to demonstrating the safety of our biologic biopolymer ORTHO-R and achieving Phase II readiness at this time next year,” ChitogenX CEO Philippe Deschamps commented.
“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.”
The company noted that the original US Phase I/II trial was to include a total of 78 patients at 10 clinical sites throughout the US and the return on investment required to complete the full recruitment was difficult to justify based on the little incremental benefit expected statistically.
ChitogenX is a clinical-stage regenerative medicine company dedicated to the development of novel therapeutic tissue repair technologies to improve tissue healing.
~Updated with share price movement~
Contact the author at stephen.gunnion@proactiveinvestors.com