Mallinckrodt affirms enlisting of first patient for ExpressGraft C9T1 Phase 1 Study
Study of Genetically Engineered Human Skin Substitute to Assess Safety and Tolerability in the Treatment of Diabetic Foot Ulcers
Mallinckrodt plc confirmed the enrollment of first patient for the company’s Phase 1 study evaluating the safety and tolerance of ExpressGraft C9T1 skin tissue in the treatment of subjects with diabetic foot ulcers. ExpressGraft C9T1 skin tissue has been genetically modified to express elevated levels of the human cathelicidin host defense peptide.
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 having foot ulcers.
Thomas E. Serena, MD, FACS, FACHM, MAPWCA, CEO and Medical Director SerenaGroup and lead investigator for the ExpressGraft-C9T1 skin tissue study said “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.”
Lynn Allen-Hoffmann, Senior Vice President of Regenerative Medicine at Mallinckrodt said ” Mallinckrodt is committed to providing treatment options for patients with unmet medical needs. Enhancement of antimicrobial action through genetic modification may benefit patients with chronic, difficult-to-heal wounds such as those seen in patients with diabetes.”