Should be a PR on new protocol relatively soon.
FDA guides Immune Pharma on design on late-stage study of Ceplene/IL-2 in AML; trial should commence in 2017; shares up 38%
Oct. 27, 2016 1:09 PM ET|About: Immune Pharmaceuticals... (IMNP)|By: Douglas W. House, SA News Editor
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.
