ENGLEWOOD, Colo., September 12, 2018, /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced a basic science manuscript entitled “Clinically relevant re-differentiation of fibroblast-like chondrocytes into functional chondrocytes by the low molecular weight fraction of human serum albumin,” authored by Melissa Hausburg, PhD; Elizabeth Frederick, PhD; Patrick McNair, MD, John Schwappach, MD, Kaysie L. Banton, MD, Michael Roshon, MD-PhD, Mark J. Lieser, MD, David L. Acuna, MD, Rahul R. Banerjee, MD, David Bar-Or, MD was accepted for publication in Clinical and Experimental Rheumatology. This is the 11th peer-reviewed publication that explores how multiple, interrelated, molecular mechanisms work synergistically to provide patients severely afflicted by Osteoarthritis of the knee (OAK) not only with near-term pain relief and improved function but also in vitro evidence of potentially disease-modifying regeneration of cartilage.
Dr. David Bar-Or, a member of Ampio’s Scientific Advisory Board (SAB) and senior author, explains “This paper provides preliminary evidence that Ampion™ may trigger and support new cartilage growth in joints affected by Osteoarthritis (OA). As OA develops, the cells that make up cartilage, chondrocytes, begin to malfunction, contributing to cartilage breakdown. If the malfunctioning chondrocytes re-started normal function, the breakdown of existing cartilage would cease, and new cartilage may form, contributing to increased joint function”.
Dr. Bar-Or continues, “In the work reported in this manuscript, we treated malfunctioning chondrocytes in vitro multiple times with Ampion over a period of either one or two weeks. We show that Ampion treatment of chondrocytes suppresses the production of IL-6, a pro-inflammatory cytokine associated with OA progression. Furthermore, Ampion induced critical cartilage proteins, SOX9, COL2, and aggrecan, which support functional chondrocytes. In cartilage, aggrecan bound to glycosaminoglycans enables cartilage to bear high compressive loads, and we were able to ascertain that newly formed aggrecan was integrated into a matrix with increased glycosaminoglycans in chondrocytes treated with Ampion.
Ampion, a derivative of human serum albumin, has also been shown to be extremely safe. There have been no adverse drug-related side effects reported in multiple clinical trials. In addition to the beneficial effects on pain and function in OAK patients, there is preliminary evidence that Ampion treatment may delay the time for total knee replacement in patients with OA and may prevent post-traumatic OA, acting as a disease-modifying agent when used after traumatic joint injury. Since all joints can be affected by acute injury to the articular cartilage, these data support prophylactic intra-articular treatment with Ampion following traumatic injury for OA prevention.”
A link to the full manuscript will be made available when it is published online.
Regulatory Exclusivity and IP protection:
The Company believes that Ampion™, a low molecular weight fraction of human serum albumin with anti-inflammatory properties, will be identified as a “reference product” upon FDA approval of their BLA. Reference products are granted twelve years of exclusivity under the PHS Act, 42 U.S.C. § 262(k)(7). Specifically, FDA is not permitted to approve an application for a biosimilar or interchangeable product until 12 years after the date of the first licensure of the reference product. The existing Ampion™ portfolio has patent coverage in all major jurisdictions throughout the world (U.S., Europe, Australia, Brazil, Canada, China, Eurasia, Hong Kong, India, Indonesia, Israel, Japan, Korea, Mexico, Malaysia, New Zealand, Philippines, Singapore, South Africa) for pharmaceutical compositions and methods of treating a range of conditions. The portfolio includes 125 issued patents and 85 pending applications throughout seven primary patent families having expiration dates that extend to 2035.
Osteoarthritis (OA) is an incurable and progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. The incidence of developing osteoarthritis of the knee over a lifetime is approximately 45%. As this disease is associated with age, obesity, and diabetes this number will continue to grow. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. Osteoarthritis is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.
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.
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 the use of words such as “believe,” “expect,” “plan,” “anticipate,” and similar expressions. These forward-looking statements include statements regarding Ampio’s expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties. 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 other documents filed with the Securities and Exchange Commission. 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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