TJG Wednesday, 11/11/20 06:53:43 AM Re: None Post # of 1124 Testing moves forward. Ampios Phase I Study For Inhaled Ampion Advances To 2nd Group Of COVID-19 Patients With Respiratory Distress 4:01 PM ET 11/10/20 | Dow Jones ENGLEWOOD, Colo., Nov. 10, 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 that the second group in the Phase I inhaled Ampion(TM) clinical study is being treated following clearance by the Safety Monitoring Committee (SMC) who found Ampion to be safe and well-tolerated after reviewing the results from the first treatment group. Michael Macaluso, Ampio's, President and CEO, clarified specific features of this clinical trial: -- "Ampion will be administered to patients by inhalation, allowing the drug to directly target and attenuate inflammation in the lungs, using a hand-held nebulizer for COVID-19 patients early in the disease and non-invasive ventilation (face mask) and mechanical ventilation (intubation) if their disease state is more severe. -- This US study will enroll 40 patients, randomized 1 to 1, inhaled Ampion versus Standard of Care (SOC), with each patient inhaling 8 mL doses of Ampion four (4) times a day for five (5) days. Safety is the primary end point and various measurements indicative of efficacy are secondary endpoints. -- Each of the first three patient groups receiving inhaled Ampion will be assessed by the SMC for an additional three days after the 5 day treatment period (as inhalation is a new method of administration of Ampion cleared for clinical use by the FDA) and if no safety concerns arise, open enrollment at the speed of recruitment will follow the remainder of the 40 patients." Mr. Macaluso further noted, "The FDA has now cleared two types of administration of Ampion for treatment of COVID-19 patients, inhalation and intravenous. In addition, a third method of administration, direct injection into the knee for patients suffering from severe osteoarthritis-of-the-knee, supports the Company's belief that Ampion is a platform drug, potentially useful for a number of inflammatory diseases throughout the body. We are currently investigating a similar inhalation study overseas that we are planning to run in close proximity with the US study. We will provide an update with more information as it develops."