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News Breaks
February 25, 2013
06:42 EDTAMPEAmpio modifies Ampion IND to include dose escalation run-in study
Ampio Pharmaceuticals announced that it's Phase III clinical study of Ampion for the treatment for osteoarthritis of the knee will include a dose-escalation run-in study as recommended by the FDA. Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, noted "The company has modified the original study design to accommodate the FDA recommendations and submitted this upgraded IND study protocol for clearance to begin treating patients. A Clinical Research Organization has been engaged and multiple clinical sites have been selected that are ready to enroll patients in the study. The dose ranging run-in study will commence shortly and will include 320 patients in total comparing 4 ml to 10 ml injection using the WOMAC pain scale."
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April 21, 2015
09:14 EDTAMPEAmpio to host business news update conference call
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April 20, 2015
08:49 EDTAMPEAmpio announces STRIDE study AP008 did not reach its primary endpoint
Ampio Pharmaceuticals announced that the multiple injection STRIDE study AP008 did not reach its primary endpoint against the saline control even though there was a statistically significant reduction in pain compared to baseline for patients receiving Ampion. This pain reduction with Ampion was consistent across all sites and with our previously reported studies Ampion is safe and well tolerated. Ampio Pharmaceuticals launched the Phase III program for AmpionTM to treat pain due to osteoarthritis, OA, of the knee. Each patient received three 4ml intra-articular injections of Ampion, or the saline placebo, one at baseline, the second at two weeks and the third at four weeks. In OA, saline is known to be a partial therapeutic and not a true placebo, but has been the control used in all published OA drug trials.

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