Wednesday, November 25, 2020 9:19:16 AM
Ampio Updates Regulatory and Clinical Trial Events
9:15 AM ET 11/25/20 | Dow Jones
ENGLEWOOD, Colo., Nov. 25, 2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, announced today the following updates:
-- Patients experiencing respiratory distress due to COVID-19: In the Phase
I inhaled Ampion(TM) clinical trial (AP-014), the third of three initial
safety groups of patients have completed their five days of treatment and
three days of follow up for Safety Monitoring Committee (SMC) review (as
inhalation is a new delivery method of Ampion cleared for clinical use by
the FDA). Once the SMC provides confirmation regarding no safety concerns
for this third group, the trial will accelerate to complete the remaining
thirty-four patients at the speed of recruitment with additional hospital
groups added as required to support enrollment.
-- Patients with severe osteoarthritis of the knee (OAK): The amendment to
the OAK Phase III clinical trial (AP-013), that harmonizes the FDA
agreement on the Special Protocol Assessment (SPA) with FDA guidance for
clinical trials on hold due to COVID-19, has been received by the FDA.
The FDA notified the Company that a formal response will be provided by
the end of this year.
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- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 02/28/2024 08:46:20 PM
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