BirchBioMed has received approval from Health Canada to initiate a Phase II clinical trial of FS2, a treatment designed to prevent scarring and breakdown of existing scars.
A total of 55 patients will be enrolled in the trial, which has appointed burn trauma and scarring expert Dr Anthony Papp as the principle investigator.
The proposed trial will primarily investigate the effectiveness of FS2 in preventing post-surgical scar formation.
It will be carried out in Vancouver, British Columbia, Canada, through Vancouver Coastal Health Research Institute (VCHRI) and University of British Columbia (UBC), with an aim to mitigate post-surgical scar formation in patients who have recently received skin-grafting procedures to repair their wounds.
Skin-grafting involves the removal of skin from one area of the body and transplanting it to another that will have difficulty healing because of its severity.
Papp said: “As a burn surgeon, I see the horrific effects of scarring every day.
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“This first Phase II study is an important, major milestone in the treatment of scarring, as there is no therapeutic on the market today that has shown the unequivocal results that FS2 has demonstrated in robust pre-clinical scar models.”
The FS2 treatment technology has been discovered by a team of UBC researchers led by UBC surgery professor Dr Aziz Ghahary.
It has the potential to help millions of people across worldwide, noted BirchBioMed, which owns an exclusive licence from UBC to develop anti-scarring drugs and autoimmune therapies based on FS2.