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May 27, 2014
08:37 EDTTLOGTetraLogic announces selection of Phase 2 dose for birinapant, azacitidine study
TetraLogic announced that, based upon data from its Phase 1b study of birinapant in combination with azacitidine in patients with relapsed/refractory or na´ve higher risk MDS, it selected a dose of 13mg/m2 twice weekly for three weeks out of four to be used in its Phase 2 clinical trial. The primary objective of the Phase 1b clinical study is to characterize the safety and tolerability and determine the recommended phase 2 dose of birinapant when administered in combination with azacitidine. Additional objectives of the study are to assess any preliminary indications of efficacy and pharmacodynamics of the combination.
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December 18, 2014
07:14 EDTTLOGTetraLogic initiates SHAPE Phase 2 clinical trial
TetraLogic Pharmaceuticals announced the initiation of a randomized Phase 2 clinical trial of SHAPE in subjects with early stage cutaneous T‑cell lymphoma, or CTCL. SHAPE has been evaluated in a randomized, dose escalation, placebo-controlled Phase 1 clinical trial in early-stage CTCL subjects that met safety endpoints and demonstrated clinical activity. Four of fifteen patients receiving SHAPE attained an objective response as measured by a greater than 50% improvement in their Composite Assessment of Index Lesion Severity, or CAILS, score during and after 28 days of dosing. No placebo patients responded. The randomized Phase 2 trial will be conducted in approximately sixty subjects with Stage IA-IIA CTCL. The objectives of the Phase 2 clinical trial are to evaluate the dose, clinical effect at 6 months, time to response, and tolerability of treatment of greater than 2% body surface area.
December 17, 2014
09:05 EDTTLOGTetraLogic sell-off yesterday overdone, says Needham
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December 16, 2014
12:26 EDTTLOGOn The Fly: Midday Wrap
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07:12 EDTTLOGTetraLogic provides update on ovarian cancer study
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December 7, 2014
14:10 EDTTLOGAmerican Society of Hematology to hold a meeting
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