Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE)("Ampio") announced that it received ethics board approval for a Phase 1B clinical trial in Australia of its biologic anti-inflammatory agent, Ampion™. Patients are now being recruited for first dosing in the three arm, placebo controlled, 60 patient trial designed to demonstrate efficacy in the treatment of osteoarthritis of the knee as well as to confirm patient safety and tolerance.
The present "standard of care" treatment for this condition is the injection of a short acting local anesthetic agent combined with a long acting steroid into and around the joint. In the Ampion trial the mitigation of pain
and loss of function caused by osteoarthritis will be assessed at intervals from the time of injection. Patients will be evaluated for 72 hours and various parameters will be followed to demonstrate that Ampion™ is well tolerated and provides pain relief
through decreased inflammation as well as demonstrated improvement in the range of motion of the knee.
Dr. David Bar-Or, MD, Ampio's Chief Scientific Officer, noted, "We discovered this molecule in patients with severe head injury who experienced decreased immune/inflammatory function. The molecule is produced in the body from our own serum albumin and is the most abundant protein in human plasma. We realized from our studies in human tissue that this molecule is an integral part of the innate control of inflammation. We know of many molecules made by our body that increase inflammation but of very few that decrease it. We are hopeful that Ampion™, with few or no side effects, will provide real relief for patients suffering from chronic inflammatory conditions," stated Dr. Bar-Or.
Ampio CEO Don Wingerter noted, "Since Ampion™ is a biologic product made by our bodies, we believe there is the probability of markedly greater safety than steroids or other anti-inflammatory drugs....