Ampio commences new anti-inflammatory agent Phase 1B trial in osteoarthritis

Jun 1 2011

Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE)("Ampio") announced today 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. We anticipate this clinical trial will demonstrate sufficient proof of safety and efficacy to allow longer term studies in which relief may be obtained without prolonged use of steroids, especially when knee replacement is not an option. We are hopeful this drug will provide clinical utility and safety greater than products now selling in the multi-billion dollar market for anti-inflammatories."

Vaughan Clift, MD, Ampio's Chief Regulatory Officer added, "We are very grateful to our Australian Principal Investigators, Dr. Peter Lewis and Dr. Andrew Comley, who helped in the design of the trial and approval process and whose leadership has resulted in encouraging support from local General Practitioners who are also identifying and referring patients into this AIK (Ampion in knee) trial. We expect the trial results will form the basis for submissions to various regulatory agencies to conduct Phase II/III studies of the active component in numerous inflammatory conditions.  We believe the nature of the compound and its human origin should facilitate a faster regulatory approval path in most countries compared to the traditional new drug therapies."