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Patient Enrollment Completed for Fibrostat Phase 2 Trial
The placebo-controlled, double-blind, randomized Phase IIb clinical trial is currently ongoing at 12 centers across Canada and the United States. The primary objective of this trial is to evaluate the safety and efficacy of Fibrostat® 0.8% for the treatment of excessive scar formation. The study design includes a four-week run-in period with the cream base only followed by an eight-week treatment period with Fibrostat® or placebo for patients who failed to improve with the base alone. This design is intended to minimize the placebo effect that is often observed in vehicle cream-controlled trials due to occlusion and hydration. Scar assessment from randomized to end of treatment is conducted by a 3-physician blinded photo review panel composed of world-renowned plastic surgeons, namely Professor Thomas Mustoe MD, Northwestern University, The Feinberg School of Medicine, IL, U.S.A.; Dr. Kenneth Dolynchuk, MD, Ph.D., St. Boniface Hospital, Winnipeg, MB, Canada; and Dr. Garry Brody MD, University of Southern California, CA, U.S.A.
“We are very proud to report that this landmark study is progressing well with the completion of the patient enrollment phase,” said Hans J. Mäder, President and Chief Executive Officer of Procyon. “This study on the management of hypertrophic scars is the first of its kind and Procyon is most pleased to act as a pioneer in this field which clearly represents an important unmet medical need. We are currently discussing with potential partners for Europe and Japan and hope to secure a partnering agreement once the final Phase IIb data is available” he added.
Following completion of the Phase IIb clinical trial of Fibrostat® and regulatory approval of Phase III protocols, Procyon intends to conduct separate pivotal studies in Europe and North America in collaboration with licensee partners for these respective regions.
Background on hypertrophic scars
Hypertrophic scars resulting from surgical incisions and/or burns are generally red, thick and elevated, and depending upon severity, they generally cause serious pain and itching. If the scar is located on a joint surface, mobility may be restricted. In the wound healing process, the enzyme tissue transglutaminase plays a role in the production of ε-(γ-glutamyl) lysine cross-links to form insoluble collagen matrices. In hypertrophic scarring this enzyme is found to be over-expressed resulting in an “over-healing” process and an excess deposition of collagen. Clinical evidence suggests that Fibrostat® inhibits the activity of the enzyme tissue transglutaminase and promotes normal healing.
According to the scientific literature, the incidence of hypertrophic scarring following surgery is high: 39% in Caucasians and 68% in Orientals, and 33% and 91% in Caucasians and Orientals respectively after burns. Up to 15% of the general population is affected by hypertrophic scarring following wounding (as high as 90% in darker skinned people). There are currently no FDA-approved commercialized topical preparations with an active pharmaceutical ingredient indicated for hypertrophic scars. Potential worldwide revenues to a partner have been estimated by Procyon to be CA$ 600 million annually. Procyon will receive a double-digit royalty on this figure along with upfront and milestone payments from its licensee partners.
Source: Procyon Biopharma