March 10, 2015
Stratatech Announces Positive Top-Line Results
from Proof-of-Concept Study of StrataGraft® Skin Tissue
in Patients with Severe Burns
MADISON, Wis., March 10, 2015 – Stratatech Corporation, a leader in regenerative medicine, today announced top-line results from a mid-stage clinical study of StrataGraft® skin tissue in patients with deep partial-thickness burns. The study goal was to assess product safety and efficacy as measured by degree and durability of wound closure. Under the study protocol, each patient received a single randomized treatment of StrataGraft tissue on one burn site and an autograft on a comparator site. Twenty-seven of 28 per-protocol patients (96%) for whom data was available at the three month primary endpoint had complete wound closure of their StrataGraft treated site.
Currently, patients who incur severe burns that are not expected to heal on their own undergo autografting, a surgical procedure involving the harvesting and transplantation of the patient’s own skin from an uninjured donor site to the trauma site. Although this regimen has been the standard of care for decades, donor sites are very painful, at risk of infection until healed, and longer term remain fragile, have a different skin tone and/or develop a permanent scar. Availability of a universal skin substitute to directly treat burns and eliminate or reduce the need for autografting would fundamentally alter the treatment, recovery and long-term health of these patients.
“Patient outcomes in this study far exceeded our expectations, and are unprecedented in this patient population. This is the first severe burn therapy that has shown the potential to avoid painful skin transplants and regenerate the patient’s own skin,” said B. Lynn Allen-Hoffmann, Ph.D., Stratatech’s chief executive and chief scientific officer. “Based on a very positive guidance meeting with the FDA, we plan to submit an IND amendment in coming weeks to initiate a Phase III registration study. If the study meets its primary endpoints, we will then file a Biologics License Application for StrataGraft use in this indication.”
About StrataGraft Regenerative Skin Tissue
The Company’s flagship product is a viable, human cellular therapeutic being developed as a treatment for severe burns. It was designed to mimic natural human skin, with both dermal and fully differentiated epidermal layers, and is cryopreserved to sustain a long shelf life. This biologically active tissue has barrier function comparable to intact human skin. In addition to providing immediate wound coverage to minimize fluid loss, numerous antimicrobial peptides, growth factors, and cytokines expressed and secreted by the viable cells of StrataGraft tissue facilitate regeneration of the patient’s own skin. StrataGraft tissue was granted an Orphan Product Designation in 2012 by the FDA for the treatment of partial and full-thickness burns.
StrataGraft tissue is being developed with support from, and in collaboration with, the U.S. Department of Defense, Armed Forces Institute of Regenerative Medicine, and the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA) under contract #HHS0100201300017C.
About the Design of the Study
This multicenter human clinical trial was designed to assess the safety and efficacy of StrataGraft skin tissue in promoting the healing of deep partial-thickness burns without the need for autografting. Each patient had two comparable areas identified and randomized to receive autologous skin grafts or StrataGraft skin tissue. In this dose escalation study, 3 cohorts of 10 patients each received a single application of StrataGraft skin tissue immediately after surgical excision of non-viable tissue. Cohort 1 received up to 220 cm2 of refrigerated StrataGraft skin tissue, Cohort 2 received up to 440 cm2 of refrigerated StrataGraft tissue, and Cohort 3 received up to 440 cm2 of cryopreserved StrataGraft tissue. The primary endpoints were wound closure after 3 months and percentage of the initial StrataGraft treatment site requiring autografting by Day 28. Additional assessments included wound and donor site cosmesis, pain of donor sites, immunological responses to StrataGraft skin tissue, and persistence of allogeneic DNA.
The final patient assessment was completed in October 2014. The key findings are as follows.
No study sites treated with StrataGraft skin tissue required autografting by Day 28.
Twenty-seven of the 28 per-protocol subjects for whom three month data is available had complete wound closure of both the StrataGraft-treated and autografted study sites at the three month study session, with the 28th subject exhibiting 85% re-epithelialization at three months.
StrataGraft DNA was undetectable in all assessed patients at three months, confirming the patient’s skin had been regenerated with their own cells.
There was no evidence of infection at any of the StrataGraft treated sites.
The cosmesis of StrataGraft treated sites exceeded expectations and was superior to that of the autograft control in some patients. Once closed, the StrataGraft treated wounds generally had a smooth, supple appearance. Cosmesis assessments performed by clinicians for StrataGraft and autograft study sites were comparable.
Detailed results will be submitted for publication.
About Severe Burns
The American Burn Association estimates that 1.1 million people suffer burns annually in the United States. Of these, approximately 40,000 patients are hospitalized for treatment, and 30,000 are admitted to 127 specialized burn centers located throughout the country.
About Stratatech Corporation
Stratatech is a privately held regenerative medicine company focused on developing skin regeneration therapies. These products are made using the company’s proprietary NIKS® cells – a consistent and well-characterized source of human keratinocyte progenitor cells that faithfully reproduces normal epidermal skin architecture and barrier function. The company is using these progenitor cells to create a portfolio of therapeutic tissues to treat severe burns, non-healing ulcers, and other complex skin defects. The company’s flagship product, StrataGraft® tissue, is in human clinical testing for the treatment of severe burns and other traumatic skin loss. The company’s second therapeutic product, ExpressGraft™ anti-infective tissue, is on track to enter clinical testing to treat non-healing diabetic foot ulcers.