Date: 2012-04-23
Type of information: Results
phase: 2
Announcement: results
Company: Adocia (France)
Product: BioChaperone® PDGF-BB (Platelet Derived Growth factor)
Action
mechanism: protein. BioChaperone PDGF-BB is a formulation comprising PDGF-BB and one polymer of the proprietary BioChaperone ®platform. Adocia specifically designed this polymer to form a molecular complex with PDGF-BB to protect it from enzymatic degradation. This protection sustains the efficacy of PDGF-BB and permits to reduce the frequency of application by two and even to reduce the dose by three.
BioChaperone also stabilizes PDGF-BB in the vial at neutral pH for 3 months at room temperature. The spray device guarantees the sterility of the solution after multiple uses. This property permits to avoid the usage of antibacterial agents which are deleterious for cell proliferation.
Disease: diabetic foot ulcer
Therapeutic area: Metabolic diseases - Cardiovascular diseases
Country: India
Trial
details: The multicentric trial has enrolled 192 patients in 4 groups consisting in the application of one of the three doses of BioChaperone PDGF-BB (14.5, 43.75 and 87.5 ?g of PDGF-BB per cm² and per week) and Regranex® (43.5 ?g per cm² and per week). BioChaperone PDGF-BB treatments were administered once every two days whereas Regranex® was administered once a day, in compliance with the trial protocol that was approved by both US and European regulatory agencies. The trial was not blinded due to the obvious difference in the medications, a spray for BioChaperone PDGF-BB and a gel for Regranex®. Treatments lasted 20 weeks or until complete healing.
The objective of the study was to establish the non-inferiority of BioChaperone PDGF-BB compared to Regranex®.
Latest
news: Adocia has announced positive results from its Phase II clinical trial evaluating the safety and efficacy of BioChaperone® combined with PDGF-BB (Platelet Derived Growth factor)for the treatment of diabetic foot ulcer. This product has been compared with Regranex®, a commercially available hydrogel of PDGF-BB (HealthPoint, initially launched by Johnson & Johnson).
Analysis of negative side effects, collected through the intent-to-treat (ITT) population of 192 patients did not identify any serious side effect related to the treatment. These safety results indicate that BioChaperone PDGF-BB is well tolerated and safe at the three doses tested, for treatment periods up to 20 weeks.
The primary endpoint is the percentage of complete wound closure at 20 weeks. The rates of complete wound closure are all superior or equal to 66% after 20 weeks, therefore proving success on non-inferiority criteria for the three tested PDGF-BB doses.
One of the most promising results is the 80% rate of complete wound closure at 20 weeks obtained with the dose of BioChaperone containing one-third of the Regranex®equivalent of PDGF-BB dose and with only one application every two days.
For the three tested doses, secondary efficacy endpoints, ie the percentage of complete wound closure at 10 weeks, the time to achieve complete wound closure (expressed by Kaplan-Meier median) and the percentage of reduction in wound area are all considered as non-inferior compared to Regranex ®.
These clinical results will be presented in major scientific congresses on wound healing, at the European Wound Management Association in Vienna, Austria, on May 23-25, 2012 and at the World Union of Wound Healing Societies in Yokohama, Japan on September 2-6, 2012.
Adocia is now actively preparing a phase III trial which could be launched in the fourth quarter of 2012 in India and two phase III clinical trials in the United States and in Europe are planned for the second half of 2013.
