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>> No.1281883 [View]
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1281883

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Twenty-eight of 34 patients were evaluable for response at the six month time point. After six months of treatment, eight 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 18 had stable disease. Using the modified Severity Weighted Assessment Tool, or mSWAT, a secondary endpoint in the clinical trial, 11 of 34 patients responded and a further 14 patients had stable disease at the six month endpoint.

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. Thirty-eight percent of patients demonstrated a clinically meaningful decrease in pruritus during the clinical trial as measured by a Visual Analog Scale. 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.

Phase 2 results will be announced sometime this month. It's also worth mentioning they have 9 times their market cap in the bank.

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