Ampio completes enrollment phase of Australian Ampion In Knee trials

Jan 3 2012

Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) ("Ampio" or the "Company"), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), today announced that it is has completed the expanded patient enrollment phase of its Ampion™ In Knee (AIK) trials in Australia. Forty-two (42) patients were added to the original sixty (60) patient study.

Dr. Vaughan Clift, Chief Regulatory Officer of Ampio, noted, "The initial trial was an important clinical milestone for the company as it was the first time that Ampion™ was administered as a treatment for an inflammatory condition in humans and was well tolerated with no reported treatment related adverse events. Details of the initial trial can be found on the Australian clinical trials register at

Dr. Clift continued, "Dr. Bar-Or, Ampio's Chief Scientific Officer, discovered the Ampion™ molecule while studying patients with immune suppression following head injury and has published numerous scientific papers on its immune modulating effect in vitro in prominent scientific journals and presented his findings at national and international scientific meetings.  Because Ampion™ is a molecule produced by humans in response to injury, is present in commercial human serum albumin (HSA) preparations that have been administered intravenously to restore the oncotic pressure of millions of hypoalbuminemic patients, we have gained substantial comfort about the safety profile of this small molecule-Ampion™.  Further, as blood derived products are currently managed by the Center for Biologics Evaluation and Research (CBER) division of the FDA, we believe Ampion™  will be classified and regulated as a biologic. The raw clinical data from the trial is now being evaluated by biostatisticians employed by the Clinical Research Organization that has conducted the trial and results are expected to be available in the next four to six weeks.

"We are hopeful this naturally occurring molecule may provide safe and effective pain relief in humans," commented Dr. Bar-Or. "Medical treatment of chronic pain would be improved if physicians were able to prescribe an effective analgesic/anti-inflammatory medicine without the damaging side effects associated with steroids, such as infection, ruptured tendons and weakening of joints when injected locally."

SOURCE Ampio Pharmaceuticals, Inc.