Immune Pharmaceuticals Inc (NASDAQ:IMNP) has announced the receipt of guidance from US FDA, for a combinational phase-3 study of Ceplene, with low dose IL-2. The study is aimed at maintaining remission in patients with Acute Myeloid Leukemia. It should be noted here that the combinational drug has already been approved for use in Europe and Israel. The approval had been granted after the drug met its primary endpoint, in a phase-3 study, of Leukemia free survival.
The new study design has already been reviewed by the FDA, with its primary endpoint being overall patient survival, while Leukemia free survival is the secondary endpoint. The company stated that the agency has provided some feedback on design elements of the study, which would be addressed in the final protocol. IMNP expects to submit the final protocol, as early as the start of 2017. Immune also noted that this study would be conducted at a global level.
The CMO of Immune, Monica Luchi M.D, expressed her pleasure at the outcome of the FDA meeting. She claimed that this meets their goal to address the unmet and urgent medical need for remission maintenance, in AML patients. However, the phase-3 trial is not the only thing on Immune’s plate, as it recently formed a management team for its subsidiary, Maxim Pharmaceuticals.
The subsidiary is focused on pain management and neurology. IMNP recently signed an agreement with Joseph V. Pergolizzi Jr. M.D, to provide consulting services and form a scientific advisory board, as well as a board of directors and an operational management team for Maxim. The company stated that this was being done to further the development of Amiket and to acquire additional assets for neurology and pain management. The acquisition targets are being evaluated on basis of a 505(b)2 path possibility.
Immune Pharmaceuticals Inc (NASDAQ:IMNP) closed at a share price of $0.255, at the end of the October 27 trading session, 38% higher than the session before, on a trade volume of 19.72 million.