October 7, 2010
Defense Department funds next phase of Stratatech clinical trial
MADISON, Wis., October 7, 2010 – Stratatech Corp., a regenerative medicine company focused on the commercialization of cell-based, tissue-engineered skin substitute products, today announced that the Defense Department’s Armed Forces Institute of Regenerative Medicine (AFIRM) will fund the Phase IIb clinical trial of the company’s flagship StrataGraft® living human skin substitute tissue.
“Stratatech is very pleased to be selected to receive this AFIRM funding, which will advance the clinical testing of our StrataGraft® tissue,” said Lynn Allen-Hoffmann, Ph.D., Stratatech’s founder, chief executive and chief scientific officer. “This phase of our StrataGraft® clinical trial is a major step forward in our efforts to commercialize a product that should provide significant benefits to patients with severe burns, wounds and other traumatic skin injury. We look forward to working with our collaboration partners towards a successful clinical trial outcome.”
Stratatech’s clinical trial is one of only three trials selected nationally in 2010 by AFIRM for funding. AFIRM’s funding of Stratatech’s StrataGraft® clinical trial totals $3.95 million. The company announced in April that it also had raised $3.0 million from its current investors to support the advancement of the clinical trial. The clinical trial is expected to start during the first half of 2011.
The goal of the Phase IIb trial is to assess the efficacy of StrataGraft® tissue as a true skin substitute in the healing of excised, deep, partial-thickness burns that otherwise would require skin grafting. The successful completion of Phase IIb will move the company closer to regulatory submission, approval and commercialization of its StrataGraft® product. During the previous Phase I/IIa clinical trial of its StrataGraft® tissue, the company achieved its primary clinical endpoints, which related to the safety and early efficacy of the tissue in patients with third-degree burns and other complex skin defects. No adverse events were deemed to be associated with exposure to StrataGraft® tissue in the Phase I/IIa trial.
“StrataGraft® tissue is a very exciting technology, with promise to be a clinically-efficacious, off-the-shelf skin substitute,” said James H. Holmes IV, M.D., professor of surgery at the Wake Forest University School of Medicine and the Wake Forest Institute of Regenerative Medicine (WFIRM), and medical director of the Wake Forest University Baptist Medical Center Burn Center. “The AFIRM funding is an indication of the Department of Defense’s agreement with this outlook and represents its continued support of improved outcomes for our wounded warriors. The AFIRM trial is the next step on the path to demonstrating StrataGraft’s clinical efficacy as a skin substitute and we anticipate exciting, positive results.”
This multi-center clinical trial will be conducted as a collaboration between the U.S. Army Institute of Surgical Research, Fort Sam Houston, Texas; the University of Wisconsin-Madison Hospital and Clinics, Madison, Wis.; Wake Forest University Baptist Medical Center, Winston-Salem, N.C.; and the Arizona Burn Center, Phoenix, Ariz.
About Stratatech Corp. and StrataGraft® Skin Substitute Tissue
Stratatech Corp. is a Madison, Wis.-based regenerative medicine company focused on the development and commercialization of cell-based, tissue-engineered skin substitute products for therapeutic and research applications. The company’s flagship product, StrataGraft® tissue, is proceeding through a clinical trial designed to support U.S. Food and Drug Administration approval of StrataGraft® tissue for the treatment of traumatic skin loss. The company’s valuable product pipeline is based on its patented NIKS® human keratinocyte cells and is comprised of the next generation of genetically-enhanced skin substitute products that have numerous advantages over skin substitutes generated from human skin sourced by conventional means.
Stratatech’s StrataGraft® tissue is a second-generation human skin substitute that exhibits normal human skin structure and function. It is produced using the company’s proprietary NIKS® human keratinocytes, which were discovered at the University of Wisconsin. Keratinocytes are the cells that make up approximately 90 percent of the epidermis, the outer layer of human skin. NIKS® cells are a consistent source of pathogen-free, non-tumor-producing, long-lived adult progenitor cells. These cells faithfully reproduce normal human skin tissue architecture and barrier function when cultured appropriately. For more information about Stratatech, its technology, and product pipeline; please visit the company’s website at www.stratatechcorp.com.