Ampio Pharmaceuticals, Inc., a company that discovers and develops new uses for previously approved drugs and new molecular entities (NMEs), today announced it has completed the expanded patient enrollment phase of its Ampion™ In Knee (AIK) trials in Australia, adding 42 patients to the original 60-patient study.
Ampion is the company’s non-steroidal anti-inflammatory drug that appears to have a significant role in the homeostasis of inflammation. Ampio believes this gives the drug the potential to be used in a broad array of inflammatory conditions.
Ampio Chief Regulatory Officer Dr. Vaughan Clift noted the importance of the initial clinical trial, which led to the approval of the expanded trial.
“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 http://www.anzctr.org.au/trial_view.aspx?ID=343138. The absence of any adverse events in the initial AIK study provided the basis for IRB approval of this expanded trial, with 42 additional patients, each receiving either a direct intra-articular injection of Ampion or the saline placebo,” Dr. Clift stated in the press release.
Ampio Chief Scientific Officer Dr. Bar-Or discovered the Ampion molecule during his study of patients with immune suppression following head injury. He has published numerous scientific papers on the drug’s immune modulating effect in vitro in prominent scientific journals and has also presented his findings at national and international scientific meetings.
“We are hopeful this naturally occurring molecule may provide safe and effective pain relief in humans,” Dr. Bar-Or stated. “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.”
The raw clinical data from the trial is now being evaluated by biostatisticians employed by the Clinical Research Organization with results expected in the next four to six weeks.
For more information, visit www.ampiopharma.com
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