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August 8, 2014
08:34 EDTBSTC, AUXLBioSpecifics announces initiation of Phase 2 clinical study of CCH
BioSpecifics (BSTC) announced that it has injected the first patient in its placebo-controlled Phase 2 clinical trial of CCH for the treatment of lipoma. The company expects to complete patient enrollment in this trial during the first quarter of 2015. The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of CCH for the treatment of lipoma. The primary endpoint of the Phase 2 clinical trial is the reduction in the measureable surface area of the target lipomas, as determined by caliper, at six months post injection. The secondary efficacy endpoints include responders at six months post injection who show a ≥50% decrease in lipoma surface area relative to baseline between CCH and placebo, the change in the length of the target lipoma, the relative change in lipoma surface area as measured by caliper at one month and three months, and the relative change in lipoma volume as measured by MRI. The study will also gather qualitative lipoma characteristics and an assessment of patient satisfaction through a questionnaire administered to each subject prior to injection and at each follow-up visit. BioSpecifics' strategic partner Auxilium (AUXL) has the option to license development and marketing rights to this indication based on a full analysis of the data from this Phase 2 clinical trial, which would transfer responsibility for the future development costs to Auxilium and trigger an opt-in payment and potential future milestone and royalty payments from Auxilium to BioSpecifics.
News For BSTC;AUXL From The Last 14 Days
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October 30, 2014
06:13 EDTAUXLAuxilium reports Q3 EPS 27c, consensus 10c
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October 21, 2014
08:13 EDTAUXL, BSTCBioSpecifics announces FDA approval of sBLA for XIAFLEX
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October 20, 2014
17:33 EDTAUXLAuxilium announces XIAFLEX approved for treatment of up to two DC joints
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