Shots in the Knee Relieving Pain

Ampio Pharmaceuticals, a clinical trial stage biopharmaceutical company based in Englewood, Colorado, has announced the six-week results of the open label portion of its trial of multiple injections of Ampion™ into the knees of patients with osteoarthritis. This is the first part of the study, which involved patients receiving a series of three injections; the first at baseline, the second after two weeks and the third at four weeks. The goal of the study was to determine and verify the safety of Ampion™.

The primary constituent ingredient of Ampion™ is aspartyl-alanyl diketopiperazine, or DA-DKP, an endogenous immunomodulatory molecule derived from the N-terminus of HSA. Based on published pre-clinical and clinical research, DA-DKP plays a significant role in the regulation of inflammation. DA-DKP is believed to reduce inflammation by suppressing pro-inflammatory cytokine production in T-cells.

Ampion™ also contains other known small molecules that confer anti-inflammatory effects to complement the activity of DA-DKP and derive demonstrated in-vitro and in-vivo effects. The Company believes that this non-steroidal, anti-inflammatory biologic agent has the potential to treat a broad range of acute and chronic inflammatory conditions as well as immune-mediated diseases.

Vaughan Clift, M.D., Ampio’s Chief Regulatory Officer, explained. “In order to proceed with the randomized vehicle-controlled portion of the trial, we had to demonstrate safety and efficacy of three injections compared to a single injection demonstrated previously in the spring study. There were no drug related serious adverse events reported during the first 6 weeks of this current trial.”

Cliff reported that the participants’ pain scores in their knees improved by 86% at the end of the six-week trial. John Schwappach, M.D., orthopedic surgeon and the principal investigator in the Ampion™ multiple injections trial, stated, “The effects of Ampion™ are truly remarkable. I have never seen an injectable drug into the knee with this degree of pain relief and improvement of function. This will change the way we treat patients with osteoarthritis of the knee.”

Ampio’s chairman and CEO, Macaluso, said, “The results so far are very encouraging. All patients are reporting almost complete resolution of pain at week six and major improvements in function.”