BirchBioMed is cleared to begin first-of-its-kind phase II clinical trial for ground-breaking anti-scarring drug

Dr. Anthony Papp, M.D. Ph.D., a world-renowned surgeon/clinician and leading authority on burn trauma and scarring, will be the Principle Investigator for the 55-patient study.

"As a burn surgeon, I see the horrific effects of scarring every day," said Dr. Papp. "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."

BirchBioMed's phase II trial achieves a significant milestone, as the first opportunity for FS2 to make a difference in the lives of burn and trauma patients, who until now have had been unable to mitigate the devastating effects of the scars they sustain. The phase II trial will investigate the effectiveness of FS2 in preventing post-surgical scar formation. Results of the phase I study, led by Dr. Papp and researchers at UBC, were published this month in the Journal Pharmaceutical Sciences.

"Health Canada's approval to begin phase II clinical trials is a vital step in BirchBioMed's efforts to change the way medical science treats the millions of people who sustain disfiguring and often life-threatening scars every day," said Mark Miller, BirchBioMed's Chairman and Chief Executive Officer.  "FS2 is the first of its kind treatment for all forms of scarring, and it holds the potential of saving billions of dollars by changing therapeutic protocols and establishing a new state-of-the-art treatment for burns and wounds."  

Discovered by UBC Professor of Surgery Dr. Aziz Ghahary, one of the world's leading authorities on wounds and scar research, and his team, including Dr. Ryan Hartwell, co-founder of the FS2 technology and Chief Science Officer of BirchBioMed, these technologies are being viewed as important breakthroughs that have the potential to impact millions of people worldwide.

In respect to scarring, Dr. Ghahary, who also serves as the director of the British Columbia Firefighters Burn and Wound Healing Laboratory, part of the Vancouver Coastal Health Research Institute (VCHRI), said: "Until now there has yet to be a single therapeutic that can target the molecular aspects of scarring, which result from the body over-repairing after an injury, surgery or disease."

The phase II trial will be conducted in Vancouver, BC, through VCHRI and UBC. Unlike any other clinical scar study, BirchBioMed's phase II trial intends to mitigate post-surgical scar formation in patients who have recently received skin-grafting procedures to repair their wounds. A skin-grafting procedure involves the removal of skin from one area of the body and transplanting it to a wound that, because of its severity, will have difficulty healing.

BirchBioMed's CSO, Dr. Ryan Hartwell, said: "Approaches to radically reduce costs and improve treatment outcome for burn survivors and others debilitated by scars have been historically challenging, fueling the excitement and promise around our unique discoveries that for the first time address the build-up of scar protein, regardless of etiology."

Brad Wheeler, UBC's Technology Transfer Manager, said: "We are very pleased to see Health Canada's approval of BirchBioMed's phase II trials, especially considering that FS2 is the most clinically ready UBC therapeutic to be transferred to industry to date."

About BirchBioMed Inc.
BirchBioMed Inc. is a biomedical company focused on the commercialization, clinical evaluation and development of proprietary anti-scarring drugs, autoimmune therapeutics/therapies and novel strategies for transplantation. To learn more about BirchBioMed Inc., visit www.birchbiomed.com

SOURCE BirchBioMed

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