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Home/Large Joints and Extremities/Ampio Pharmaceuticals: Dosing Commenced in Hand OA Drug Trial
Large Joints and Extremities

Ampio Pharmaceuticals: Dosing Commenced in Hand OA Drug Trial

May 19, 2016 1 min read Premium comments

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Ampio Pharmaceuticals: Dosing Commenced in Hand OA Drug Trial
Courtesy of Ampio Pharmaceuticals, Inc.
Secondary

Englewood, Colorado-based Ampio Pharmaceuticals, Inc. announced today that patient dosing has begun in the initial clinical trial of Ampion for the treatment of pain due to osteoarthritis (OA) of the hand.

Michael Macaluso, CEO of Ampio, stated in the May 10, 2016 news release, “Although knee OA is a major contributor to this painful medical condition, the 2015 Global Data Epidemiology Forecast reports that hand OA is more prevalent, projecting that total cases of hand OA in the seven (7) major markets will rise from 151 million in 2014 to 176 million by 2024. As Ampio recently announced the completion of enrollment of our second pivotal clinical trial for the treatment of knee OA, we determined that it was an appropriate time to explore whether the anti-inflammatory properties of Ampion will provide a benefit to the very significant patient population with hand OA.”

David Bar-Or, M.D., clarified: “This exploratory trial is a randomized, double-blind, placebo controlled, single center study in one of the largest hand surgery clinics in the USA, to evaluate the efficacy and safety of an intra-articular injection of Ampion in adults with pain due to osteoarthritis of the hand, specifically of the first carpo-metacarpal joint of the thumb.”

Macaluso told OTW, “We have demonstrated in vitro that Ampion contributes to the migration and differentiation of mesenchymal stem cells into chondrocytes producing aggrecan and collagen 2A. Ampion also demonstrated an effect on PGD-2, a prostaglandin involved in the healing and resolution on inflammation/pain.”

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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