16 February 2018 - - Staines-upon-Thames, UK-based specialty pharmaceutical company Mallinckrodt plc (NYSE: MNK) has enrolled the first patient in its Phase 1 study assessing the safety and tolerability of ExpressGraftC9T1 skin tissue in the treatment of subjects with diabetic foot ulcers (DFU), the company said.
ExpressGraft-C9T1 skin tissue has been genetically modified to express elevated levels of the human cathelicidin host defense peptide.
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.
Mallinckrodt develops, manufactures, markets, and distributes specialty pharmaceutical products and therapies. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products.