TetraLogic Pharmaceuticals Corp (TLOG)

[fred1963]

Phase II do any day now, hope it's positive.






https://www.sec.gov/Archives/edgar/data/1361248/000155837016005275/tlog-20160331x10q.htm


On January 6, 2016, we announced that we had undertaken an interim analysis of our randomized Phase 2 clinical trial of SHAPE. The clinical trial was designed to investigate the safety and efficacy of three different dosing regimens of SHAPE in patients suffering from earlier stage CTCL. All patients in the clinical trial had received prior therapy either in the form of topical steroids, UV light therapy, topical nitrogen mustard, or some other agent. Twenty-eight of 34 patients were evaluable for response at the six month time point. Within six months of treatment, twelve of 34 patients exhibited a response to treatment as assessed by the Composite Assessment of Index Lesion Severity, or CAILS, the primary endpoint, and a further 21 had stable disease. Using the modified Severity Weighted Assessment Tool, or mSWAT, a secondary endpoint in the clinical trial, 14 of 34 patients responded and a further 20 patients had stable disease within the six month treatment period.







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"The interim results taken during this Phase 2 clinical trial demonstrated that SHAPE also showed improvement in pruritus (itch), a significant symptom associated with CTCL. Forty-five percent of all patients enrolled in the trial, entered with significant pruritus at baseline as defined by VAS score. Of these, 50% saw a clinically meaningful reduction in pruritus. In addition, the pruritus response appeared to be dose dependent, and all 8 patients on the highest dose arm experienced a clinically meaningful reduction in pruritus. SHAPE was well tolerated by patients in the clinical trial. The 60 patient clinical trial is now fully enrolled, and we expect that final results will be available in mid-2016.

SHAPE’s composition of matter patent in the U.S. extends until at least 2028. We have acquired worldwide development and commercialization rights to SHAPE for all indications."