Adocia published positive clinical phase II evaluation of safety and effectiveness of BioChaperone combined with PDGF-BB for the treatment of diabetic foot ulcers. This product was compared with Regranex, a gel currently marketed by HealthPoint, originally Johnson & Johnson.
The objective of this study was to establish for each dose of the non-inferiority BioChaperone compared with Regranex. Analysis of adverse events, collected from the intentions of treatment (intent-to-treat, ITT) population of 192 patients, showed no significant adverse events related to treatment. These results indicate that toxicity BioChaperone PDGF-BB is both well tolerated and safe for the three doses tested, as part of treatment to 20 weeks.
The primary endpoint of the study is the percentage of complete healing (wound closure) after 20 weeks. Complete healing rates are all greater than or equal to that of Regranex or 66% after 20 weeks. The criteria for noninferiority were thus obtained for the three doses of PDGF-BB that were tested. Adocia observed a healing rate of 80% after 20 weeks.
These clinical results will be presented at major scientific meetings on wound healing, the European Wound Management Association in Vienna (Austria) from 23 to 25 May 2012, and the World Union of Wound Healing Societies in Yokohama (Japan) from 2 to September 6, 2012. “We are now actively preparing for a Phase III study in India, which could be launched in the fourth quarter of 2012, and two Phase III studies in the U.S. and Europe, scheduled for the second half of 2013. The Indian study should permit the marketing of our product in emerging markets, “said Dr. Olivier Soula, VP R & D Director of Adocia.



