Ampio Announces Positive Preliminary Biochemical Findings from the Synovial Fluid of the Knees Treated in the SPRING Study
GREENWOOD VILLAGE, Colo., Feb. 13, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today 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. 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 AmpionTM or the saline vehicle control. Proteins are vital parts of living organisms, as they are the main components of the metabolic pathways of cells.
Dr. David Bar-Or, Ampio's Chief Scientific Officer, explained, "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," Dr. Bar-Or continued, "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."
Michael Macaluso, Ampio's CEO, noted that "We are pleased that the preliminary results support, and provide a basis for, the reduction of pain reported in the SPRING study. We look forward to receiving the proteomic and MRI data for presentation later in the year."
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. We are developing compounds that decrease inflammation by (i) inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level; (ii) activating specific phosphatase or depletion of the available phosphate needed for the inflammation process; and (iii) decreasing vascular permeability.
Forward Looking Statements
Ampio's statements in this press release that are not historical fact and that relate to future plans or events are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include risks associated with clinical trials, expected results, regulatory approvals, and changes in business conditions and similar events. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.
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