ENGLEWOOD, CO., June 9, 2015 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced three peer-review publications that report the multifaceted and synergistic effects of AmpionTM in the treatment of osteoarthritis in the knee.
Edward Brody, MD, PhD, Chief Medical Officer Emeritus at Somalogics Inc. and a member of the European Molecular Biology Organization (EMBO) noted, “These first two articles describe research performed by a team of molecular biologists, biochemists and physicians led by Dr. David Bar-Or, Ampio’s Chief Science Officer, that has examined the role of Ampion™ in treating chronic pain caused by osteoarthritis of the knee, followed by a review of the literature that explores the inflammatory pathways associated with osteoarthritis of the knee.”
“Collectively, these three articles suggest that changing the major prostaglandins generated after an initial inflammatory response leads to the type of anti-inflammatory response seen clinically with LMWF5A-Ampion™. The first two research papers show that Ampion™ elicits all of the biochemical changes needed for the synthesis of an anti-inflammatory prostaglandin. They also demonstrate the biochemical changes in mesenchymal stem cells (the precursors of chondrocytes and osteocytes) induced by Ampion™, all of which suggest that treatment by Ampion™ could lead to the replenishment of cartilage in this disease.”
- The first article, titled “The Low Molecular Weight Fraction of Commercial Human Serum Albumin (LMWF5A-Ampion) Induces Morphologic and Transcriptional Changes of Bone Marrow-Derived Mesenchymal Stem Cells”, and published in Stem Cell Translational Medicine on June 3, 2015 (http://www.ncbi.nlm.nih.gov/pubmed/26041739) reports that when bone marrow derived mesenchymal stem cells (MSCs), were exposed to the low molecular weight fraction of commercial albumin solution (Ampion™) in vitro, pivotal changes in cytoskeletal organization, gene transcription, and protein phosphorylation were observed following treatment that may have potential implications on stem cell renewal, regulation and differentiation. In addition, proteomic analysis of synovial fluid taken from patients (in vivo) participating in the SPRING study indicate that 12 weeks following administration of AmpionTM (different from the saline treated patients), a microenvironment exists in the knee conducive to stem cell infiltration, maintenance, and differentiation, with evidence of a reduction in inflammation and active remodeling. Based on these findings, the investigators postulate that in addition to its anti-inflammatory activity, Ampion™ treatment may prime stem cells for both mobilization and chondrogenic differentiation, potentially explaining some of the beneficial effects achieved in the AmpionTM clinical trials.
- The second article titled, “Anti-Inflammatory Activity in the Low Molecular Weight Fraction of Commercial Human Serum Albumin (LMWF5A)” and published in Journal Immunoassay Immunochem on May 11, 2015 (http://www.ncbi.nlm.nih.gov/pubmed/25961642) reports that the observed anti-inflammatory effects on immune cells provided by the non-steroid drug, Ampion™, adds to the growing evidence provided in previously published manuscripts that the anti-inflammatory properties of AmpionTM are comparable to dexamethasone (a strong anti-inflammatory steroid).
- The third article titled, “Inflammatory pathways in knee osteoarthritis: potential targets for treatment,” and published in Current Rheumatology Review on May 21, 2015 (http://www.ncbi.nlm.nih.gov/pubmed/26002457) provides a review of other peer-reviewed scientific publications that suggest up-regulating certain anti-inflammatory prostaglandins, a property demonstrated by AmpionTM (unpublished), could be a beneficial target in treating osteoarthritis.
“The Ampio scientific team is continuing to explore the anti-inflammatory and healing properties of Ampion™ in osteoarthritis and other conditions where the mechanism of action of Ampion™ would be beneficial, ” stated Dr. Bar-Or.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a clinical trial 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 “plan,” “continue”, “present,” “could,” “may,” “will be,” and similar expressions. These forward-looking statements include statements regarding Ampio’s plans with respect to the AmpionTM and its affects, which are subject to the risks associated with clinical trials, regulatory approvals, and changes in business conditions and similar events. These risks include the uncertainty of the regulatory response to the sufficiency of trial data and trial design, that regulatory approval may not be obtained or delayed, and the risks and uncertainties 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.
Gregory A. Gould
Ampio Pharmaceuticals, Inc.
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