ENGLEWOOD, Colo., November 15, 2017/PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) announced the beginning of an Open Label Extension (OLE) study of Ampion™ in patients with severe osteoarthritis of the knee (OAK). The OLE study offers patients an opportunity to receive repeat injections of Ampion™ after they have completed the pivotal clinical trial. This OLE study will address the regulatory requirements to allow an expanded commercial label for repeat administration of Ampion.
Ampion™ is the low molecular weight fraction of pharmaceutical 5% human serum albumin (HSA). HSA is the sole starting material used to manufacture of Ampion and has been given to patients for more than 60 years with a demonstrated safety profile. Ampio leverages the safety profile of HSA to develop a product for patients that has the potential to address the signs and symptoms for the unmet medical need of severe osteoarthritis of the knee.
Osteoarthritis (OA) is a 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 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™, as well as those associated with clinical trials, expected results, regulatory approvals, commercial label 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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