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FDA guides Immune Pharma on design on late-stage study of Ceplene/IL-2 in AML; trial should commence in 2017; shares up 38%

Published 10/27/2016, 01:09 PM
Updated 10/27/2016, 01:09 PM
FDA guides Immune Pharma on design on late-stage study of Ceplene/IL-2 in AML; trial should commence in 2017; shares up 38%
  • Nano cap Immune Pharmaceuticals (IMNP +38.4%) moves up on more than a 5x surge in volume in response to its announcement that it has received guidance from the FDA on the design of a Phase 3 study to assess Ceplene, in combination with low-dose interleukin 2 (IL-2), for the maintenance of remission in patients with acute myeloid leukemia (AML).
  • The company intends to submit the final study protocol in early 2017 and, if approved, to initiate the trial shortly thereafter. The primary endpoint will be overall survival (OS).
  • Ceplene (histamine dihydrochloride) acts by enhancing the immunostimulatory effects of IL-2. It was developed by EpiCept and approved in the EU in October 2008. Immune merged with EpiCept in August 2013.

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