Wednesday, June 12, 2013 8:06:46 AM
7:17AM Derma Sciences reports results from DSC127 pharmacokinetic study; DSC127 was not detected in any subject's serum samples at any time point (DSCI) 13.29 : Co announced that all data from the pharmacokinetic (PK) study with 0.03% DSC127 gel has been collected and analyzed. Subjects topically applied 0.03% DSC127 to the wound once each day for 28 days. The mean ulcer area at baseline was 9.5 cm2 (Standard Deviation 11.9 cm2). DSC127 was not detected in any subject's serum samples at any time point, using an assay with a lower limit of quantitation of 0.200ng/mL. Accordingly, no PK parameters could be calculated. All samples were also considered to be non-reactive in an assay for anti-drug antibodies. Study subjects showed no clinically significant changes in clinical chemistry, hematology, and electrocardiograms. The 0.03% DSC127 gel was well tolerated and there were no adverse events or serious adverse events considered related to the study drug, as determined by the Principal Investigator. None of the wounds treated with DSC127 gel deteriorated.
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