Date: 2014-07-25
Type of information: Interim results
phase: 3
Announcement: interim data
Company: DermaTools Biotech (Germany)
Product: DermaPro®
Action
mechanism: DermaPro® (CL05) is derived from dichloric acid. It is applied to poorly healing and chronic wounds by a moist wound dressing. DermaPro® carries out a dual function in supporting the body with the closure of wounds by stimulating both skin growth and disinfection. Since December 2013, 30 high-profile medical centres have started recruiting the 300 patients needed for the European phase III trials for the treatment of diabetic foot ulcers.
Disease:
Therapeutic area: Metabolic diseases - Cardiovascular diseases
Country:
Trial details:
Latest
news: * On July 25, 2014, DermaTools Biotech GmbH, a subsidiary of CytoTools AG, announced that more than 200 patients have already been accepted into the therapeutic phase of the 2013 launched DermaPro® Phase III study for the “diabetic foot” indication in Germany and other European countries. An initial blinded interim analysis based on data evaluated for the first 80 patients completing the study was performed by an independent DSMB on July 23, 2014. The DSMB recommends continuing the study without change. This can be deemed a clear indication that the good results achieved in the European Phase 2b study have been confirmed. An unblinded interim analysis is expected once treatment of the first 160 patients has been completed in the 4th quarter. Here, it will already be possible to provide indications as to the expected effectiveness of DermaPro® in this approval study. At a meeting held with experts from the BfArM in June 2014, the DermaPro® development plan for achieving approval was basically confirmed. No requirements were stipulated or objections raised that could delay submission of the application for approval in Europe planned for 2015.
