Mallinckrodt Enrolls First Patient in Phase 1 Study of ExpressGraft™C9T1 Skin Tissue
"I am excited that the first patient has been enrolled in this important Phase 1 study. Diabetic foot ulcers and resulting complications can be physically debilitating and lead to emotionally devastating problems in this population," said
About the Study
The Phase 1 study is titled "ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers." The study is designed as a prospective, open-label trial focused on assessing the safety and tolerability of ExpressGraft-C9T1 skin tissue in the treatment of DFU. Targeted enrollment for this study is up to six subjects with a confirmed diagnosis of diabetes and who have foot ulcers. Subjects will each receive a single application of ExpressGraft-C9T1 skin tissue on a single identified study DFU following a 10-14 day run-in period. Any subjects requiring additional treatment will receive protocol-defined dressings as necessary. Enrollment is staged with a minimum of one week between each subject.
The safety and tolerability of ExpressGraft-C9T1 skin tissue will be evaluated by monitoring adverse events, clinically significant vital signs, blood chemistry, safety laboratory values including but not limited to immunological testing, and incidence of treatment site infection through the 12-month study session.
Find more information about the trial here on the ClinicalTrials.gov website.
About Diabetic Foot Ulcers
More than 22 million people were diagnosed with diabetes in the U.S. in 2012 (7.7% of the population).1 DFUs are open sores or wounds that occur on the foot in up to 25 percent of patients with diabetes during their lifetime1,2 and are the cause of more hospitalizations than any other complication of diabetes.3 Diabetes is the leading cause of non-traumatic lower extremity amputations in the U.S. In patients with diabetes, complications of DFUs are considered the main cause of lower extremity amputations.2,4 Foot ulceration precedes 85 percent of diabetes-related amputations.5 According to the
About ExpressGraft-C9T1 Anti-Infective Tissue
ExpressGraft-C9T1 skin tissue builds on many of the same technologies pioneered in the development of StrataGraft, a skin substitute which is currently in Phase 3 for the treatment of severe burns. ExpressGraft-C9T1 is the first genetically engineered human skin substitute in development that expresses elevated levels of the human cathelicidin host defense peptide. Cathelicidin is a multifunctional human defense protein with broad-spectrum antimicrobial activity and is a mediator of wound healing through promotion of angiogenesis and epithelialization. ExpressGraft-C9T1 skin tissue and StrataGraft are both investigational products and are not approved by regulatory authorities. Safety and efficacy have not been established.
Cautionary Statements Related to Forward-Looking Statements
This release includes forward-looking statements concerning ExpressGraft-C9T1 skin tissue and its ongoing clinical trial. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; additional clinical trial results; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; future commercialization efforts; and other risks identified and described in more detail in the "Risk Factors" section of
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1 Economic Costs of Diabetes in the U.S. in 2012. Diabetes Care 36:1033–1046, 2013.
2 Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005 Jan 12;293(2):217-28.
3 Frykberg RG, Zgonis T, Armstrong DG, et al. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. Sep-
5 Pecoraro RE, Reiber GE, Burgess EM. Pathways to diabetic limb amputation: basis for prevention. Diabetes Care 1990;13:513--21.
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