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BioChaperone(Adocia) success in Phase II trial for Diabetic Foot Ulcers

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Last updated:8th May 2012
Published:8th May 2012
Source: Pharmawand
Phase II results of BioChaperone demonstrated non-inferiority in a comparison with Johnson & Johnson/Healthpoint Biotherapeutic's Regranex gel 0.01% (becaplermin).Analysis of negative side effects, collected through the intent-to-treat 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 data showed that rates of complete wound closure were all superior or equal to 66% after 20 weeks, therefore proving success on non-inferiority criteria. This clinical trial meets the main objectives with a dose reduction by three of the growth factor contained in Regranex and a reduction of the frequency of application, once every two days versus every day for Regranex. Phase III trials are planned. Adocia are a company based in Lyon France, specialising in Insulin and in Diabetic Foot therapies.

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