http://press.bequoted.com/beqpress/download.asp?id=18882
New York, NY, October 27, 2016: Immune Pharmaceuticals (NASDAQ:IMNP) (Immune)
announced today that it has received guidance from the United States Food and Drug
Administration (FDA) on a phase III study for Ceplene in combination with low dose IL-2 for
the maintenance of remission in patients with Acute Myeloid Leukemia (AML). Ceplene/IL-2
has previously been approved in Europe and Israel following a successful phase III study with
Leukemia Free Survival as the primary endpoint. The proposed phase III study design reviewed
by the FDA focuses on overall survival as the primary endpoint, along with key secondary
endpoints, including Leukemia Free Survival.
The FDA also provided feedback relating to specific design elements of the phase III study, and
with this framework, Immune plans to submit the final protocol for the phase III study in early
2017 and, upon approval, proceed with conducting a global Phase III Pivotal Overall Survival
Study in AML maintenance of response with Ceplene/IL2.
“We are very pleased with the positive outcome of our recent interaction with the FDA. Our path
forward to proceed with a pivotal study following regulatory guidance of Ceplene/IL-2 meets our
goal to address the urgent unmet medical need for remission maintenance therapy in AML,”
stated Monica Luchi, MD, Immune’s Chief Medical Officer. |
