October 31, 2011
Stratatech Awarded $4.6-Million Clinical Trial Grant for ExpressGraft® Antimicrobial Skin Substitute
MADISON, Wis., Oct. 31, 2011 – Stratatech Corp., a leader in regenerative medicine, today announced that the company has been awarded a $4.6-million grant by the National Institute of Diabetes and Digestive and Kidney Diseases to support the first human clinical trial of Stratatech’s ExpressGraft® antimicrobial skin substitute. The clinical trial will assess the safety and efficacy of the tissue as a treatment for chronic diabetic foot ulcers. This pioneering product is the first therapeutic skin substitute to be genetically enhanced to fight infection and accelerate wound healing.
ExpressGraft® skin substitute is a living, cell-based tissue with the physical, chemical and histological characteristics of human skin. When applied topically to non-healing ulcers, this tissue provides immediate wound closure and is expected to be gradually replaced by the patient’s own cells during the wound healing process. The tissue’s unique ability to produce a potent immune system protein enables it to actively fight infections that routinely develop at the site of diabetic foot ulcers.
“Stratatech will advance its second therapeutic product into clinical testing with this award, bringing us another step closer to the multibillion dollar market for chronic skin ulcer treatments,” said Lynn Allen-Hoffmann, Ph.D., Stratatech’s chief executive and chief scientific officer. “This competitive, peer-reviewed award is another validation of the compelling value of our portfolio of genetically enhanced skin substitutes.”
Stratatech’s antimicrobial skin substitute has been genetically enhanced to actively express elevated levels of cathelicidin, a naturally-occurring protein. Cathelicidin plays an active role in wound healing and has broad antimicrobial properties against gram-positive and gram-negative bacteria, viruses and other pathogens, including methicillin-resistant S. aureus (MRSA), vancomycin-resistant E. faecalis (VRE) and other antibiotic-resistant hospital-acquired infections. Data published in the journal Molecular Therapy demonstrated that genetically enhanced ExpressGraft tissue produced 140-fold greater levels of cathelicidin protein in vitro compared to unmodified control tissue. An in vivo model showed that the modified tissue reduced the growth of A. baumannii by more than 100-fold compared to unmodified tissue. A. baumannii is a pathogenic, multi-drug-resistant bacterium responsible for an increasing number of virulent hospital-acquired infections. These data elicited an independent editorial by German surgeons, who hailed this capability as a “…paradigm shift in the management of skin pathologies.”
Chronic diabetic foot ulcers are a major and rapidly growing health care concern. More than 23 million people in the United States have diabetes and an estimated 900,000 new patients are afflicted with non-healing skin ulcers each year. Diabetic lesions are responsible for more hospitalizations than any other complication of diabetes and lead to more than 80,000 amputations each year. First-generation human skin substitutes are available to help close chronic wounds, but those skin substitutes are not approved for use in infected wounds, are not effective in many patients and do not fight infection.
“Given the rapid rise of antibiotic-resistant infections, their negative affect on costs and the dearth of new anti-infective drugs, Stratatech’s innovative ExpressGraft tissue can have a significant impact on treating diabetic foot ulcers and other skin injuries” Dr. Allen-Hoffmann said.
About Stratatech Corporation
Stratatech Corp. is a privately-held regenerative medicine company focused on the development and commercialization of cell-based, tissue-engineered skin substitute products for therapeutic and research applications. These products are made using the company’s proprietary NIKS® cells – a human keratinocyte progenitor cell line that faithfully reproduces normal epidermal skin architecture and barrier function. The company is using this progenitor cell line to create a portfolio of therapeutic products 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 ExpressGraft™ antimicrobial tissue is the company’s second therapeutic product to enter clinical testing.