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news.Ampio Pharmaceuticals has announced preliminary biochemical analysis of samples of synovial fluid drawn from the index knee (treated knee) of a subset of patients who participated in the SPRING study.
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This synovial analysis, suggested by the FDA, tests the change in expression of signaling and structural proteins that arise from the treatment of the knee with either Ampion or the saline vehicle control. Proteins are vital parts of living organisms, as they are the main components of the metabolic pathways of cells.
Ampio chief scientific officer Dr David Bar-Or noted these patients received injections of either saline or Ampion and samples of their synovial fluid were collected at baseline and 12 weeks post treatment and analyzed by an independent laboratory using proteomic tools.
"Proteomic analysis provides a large-scale study of proteins, particularly their structure and function. Although the patient subset was small, we identified twenty (20) proteins that showed significant differences in the expression of certain proteins between the saline and Ampion™ groups. Thirteen (13) proteins involved with healing, mesenchymal stem cell protection, mobilization of stem cells and cartilage remodeling were up regulated (increased) in the Ampion™ treated knees synovial fluid compared to the saline ones. Seven (7) other proteins that are pro-inflammatory kinases were down regulated (decreased) by Ampion™ compared to saline.
"In addition, magnetic resonance imaging (MRI) tests conducted on a subset of patients before and after treatment (baseline and 12 weeks) demonstrated an effect on the sub-chondral region (the bone under the cartilage) in patients receiving AmpionTM compared to saline, possibly indicating the recruitment of stem cells from the adjacent bone marrow.
"This analysis of SPRING study patient synovial fluid has been expanded in the STEP study along with a further MRI analysis of index knees. Combined with the company’s In Vitro studies of the effect of AmpionTM on immune cells and mesenchymal stem cells, a comprehensive analysis of the mechanism-of-action (MOA) of AmpionTM will be compiled and presented to peer reviewed scientific journals for publication," Dr Bar-Or added.