Randomized double-blind placebo-controlled trial of flavocoxid in Duchenne muscular dystrophy

Professor Giuseppe Vita and Dr. Sonia Messina
University of Messina, Messina, Italy

Sunday 7th February 2010

Professor Dominic Wells was the lead reviewer and guided the meeting discussions and generation of the TACT recommendations report to the applicant.

In summary, a set of interesting preclinical data have been generated by the applicant on the use of flavocoxid in the mdx mouse. Further preclinical work to confirm the efficacy of the drug by using a more clinically relevant delivery method and standardised preclinical functional outcomes was suggested. The applicants would have access to an experienced group of clinical investigators to offer advice on state of the art outcome measures for the proposed clinical trial via TREAT-NMD. TACT also recommended that prior to any trial, detailed discussion with the regulatory agencies would be important due to the unapproved status of the drug (a Medical Food in the US) in Europe. For additional information interested parties should contact the applicant directly.

“All the process since the proposal submission to the final report has been very helpful for us. Your comments highlighted relevant issues of the proposal and will surely help us to strengthen the final version of the project."

Professor Giuseppe Vita and Dr. Sonia Messina

12 Apr 2017