Eftilagimod Alpha (LAG-3Ig Or IMP321) Pre-IND Meeting With the FDA
2017年11月15日 - 5:11PM
Prima BioMed Ltd (ASX:PRR) (NASDAQ:PBMD) (“Prima”) is pleased to
announce that it held a Pre-Investigational New Drug Application
(pre-IND) meeting with the U.S. Food and Drug Administration (FDA)
in November to discuss the regulatory pathway for the development
of Eftilagimod Alpha (LAG-3Ig or IMP 321) in the United States.
The FDA addressed Prima's questions related to preclinical,
nonclinical, and clinical data and design of clinical trials of
Eftilagimod Alpha in a chemo-immunotherapy setting and in an
immuno-oncology combination trial. Prima intends to file an
investigational new drug application (IND) in the first half of
calendar year 2018. After having successfully started clinical
development of Eftilagimod Alpha in Australia and Europe, an IND
would provide Prima with the opportunity to commence clinical
studies and regulatory interactions in the United States.
"The U.S. is the largest pharmaceutical market in the world, so
the pre-IND meeting regarding Eftilagimod Alpha was an important
milestone. Our meeting with the FDA was very productive and their
guidance will be most valuable in assessing the appropriate U.S.
clinical and regulatory strategies for Eftilagimod Alpha,"
said Marc Voigt, Prima's Chief Executive Officer.
Prima BioMed
Prima BioMed is listed on the Australian
Securities Exchange (PRR) and on the NASDAQ (PBMD) in the US. For
further information please visit www.primabiomed.com.au.
For further information please
contact:
U.S. Investors:Jay Campbell, Vice President of
Business Development and Investor Relations, Prima Biomed+1 (917)
860-9404; jay.campbell@primabiomed.com.au
Matthew Beck, The Trout Group LLC+1 (646) 378-2933;
mbeck@troutgroup.com
Australian
Investors/Media:Matthew Gregorowski, Citadel-MAGNUS+61 2
8234 0105; mgregorowski@citadelmagnus.com
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