Immuron US DoD Naval Medical Research Center Receives feedback on IND Application for New Campylobacter ETEC Therapeutic
July 26 2022 - 6:00AM
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian
biopharmaceutical company focused on developing and commercializing
oral immunotherapeutic products for the prevention and treatment of
gut pathogens, today announced that the US Naval Medical Research
Center (NMRC) has received feedback from the US Food and Drug
Administration following a review of the Investigational New Drug
(IND) application for a new oral therapeutic targeting
Campylobacter and ETEC.
The Agency has specified that the IND does not
contain sufficient information required under 21 CFR 312.23 to
assess the risk to subjects in the proposed clinical studies. The
IND has been placed on Clinical Hold until the FDA have received
and reviewed a response from the NMRC justifying dosing, safety
monitoring and a risk mitigation plan. The NMRC has previously
filed and had IND applications approved by the FDA on similar
colostrum-based products without being requested for supporting
pharmacology/toxicology data. The NMRC are currently addressing the
clinical hold comments and will seek a Type A meeting with the FDA
to discuss the clinical hold and the necessary protocol amendments.
The meeting will be scheduled in 30 calendar days from receipt of
the NMRC meeting request and background information package.
This release has been authorised by the
directors of Immuron Limited.
COMPANY CONTACT:Mr Steven
LydeamoreChief Executive OfficerPh: +61 (0)3 9824
5254info@immuron.com
For more information visit:
http://www.immuron.com
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