Eftilagimod Alpha (LAG-3Ig or IMP321) Pre-IND Meeting with the FDA
November 15th 2017
SYDNEY, Australia, Nov. 15, 2017 (GLOBE NEWSWIRE) -- 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 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.
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