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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.
http://www.immunepharma.com/...at-the-american-society-of-hematology/
hohes Volumen drüben
http://www.nasdaq.com/de/symbol/imnp/real-time
http://www.nasdaq.com/de/symbol/imnp/after-hours
http://www.ariva.de/news/...announces-immuno-oncology-r-amp-d-5956624
afterhour 0,265
Könnte bis zum 08.12. so weitergehen...
We will be having an Immuno Oncology R&D update, this coming Thursday, December 8th.
The event will be broadcasted on Facebook Live as a live interview with Dr Daniel Teper, Dr Monica Luchi, and Dr Miri Ben Ami, moderated by John Persino.
In addition, we will share on our website a Q&A with experts and management as well as scientific presentations.
This additional material was recorded this past weekend at the ASH Conference in conjunction with the Ceplene scientific advisory board meeting.
In order to view the broadcast, please like our Facebook page and stay tuned at 11AM ET.
Kind Regards,
Immune’s Team
http://www.immunepharma.com/immuno-oncology-rd-update/
http://www.nasdaq.com/de/symbol/imnp/premarket
Quelle: http://www.immunepharma.com/immuno-oncology-rd-update/
Mit Google-Translator-Übersetzung auf deutsch:
Wir werden mit einem Immuno Oncology F & E-Update, das kommenden Donnerstag, 8. Dezember. Die Veranstaltung wird auf Facebook Live als Live-Interview mit Dr. Daniel Teper, Dr. Monica Luchi und Dr. Miri Ben Ami, moderiert von John Persino ausgestrahlt. Darüber hinaus werden wir auf unserer Website eine Q & A mit Experten und Management sowie wissenschaftliche Präsentationen zu teilen. Dieses zusätzliche Material wurde am vergangenen Wochenende auf der ASH-Konferenz in Verbindung mit der wissenschaftlichen Beiratssitzung von Ceplene verzeichnet. Um die Sendung anzusehen, bitte wie unsere Facebook-Seite und bleibt dran bei 11 Uhr ET. Mit freundlichen Grüßen.........
http://www.nasdaq.com/de/symbol/imnp/premarket