- Published: 12 October 2017
- Written by Editor
Ampio Announces Accepted Publication of Pooled Ampion ™ Clinical Trial Results in Patients with Severe Osteoarthritis of the Knee
ENGLEWOOD, Colo., Oct. 12, 2017 -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that a manuscript titled: "LMWF-5A For The Treatment Of Severe Osteoarthritis Of The Knee: Integrated Analysis Of Safety And Efficacy" was accepted for publication in Orthopedics, an international peer-reviewed journal in the field of Orthopedics. Ampion™ is the Low Molecular Weight Fraction of 5% human serum Albumin (LMWF-5A).
Ampio's Chief Scientific Officer, Dr. David Bar-Or described the study as follows: "This was a combined analysis of all completed single-injection Ampion™ randomized placebo-controlled trials to date, focusing on the subset of patients with severe (Kellgren-Lawrence [KL] grade 4) osteoarthritis of the knee (OAK). The objective of the study was to examine the safety and efficacy of an intra-articular injection of Ampion™ compared to a saline placebo control in patients with severe OAK. Safety and efficacy measurements, subject eligibility, treatment, randomization and blinding, were identical across all trials."
Dr. Brian Cole, who co-authored the article, explained, "417 patients is thought to be the largest study treating the KL grade 4 population to be published. This pooled analysis demonstrated that a single-injection of Ampion™ was safe and well tolerated across all trials. Patients treated with Ampion™ were also significantly more likely to respond to treatment and with a longer duration of response as compared to saline. These results are clinically important and provide support for Ampion™ for the indication of pain due to severe OAK. The KL grade 4 population is an unmet medical need."
Ampion™ is in late-stage development to treat the signs and symptoms of severe OAK. Based on FDA guidance, Ampio recently completed enrollment in the 12-week pivotal trial of Ampion™, which enrolled patients with severe OAK (KL grade 4) to evaluate the efficacy of Ampion™ for the treatment of pain, function, and Patient Global Assessment (PGA). The primary study endpoint is the OMERACT-OARSI responder criteria.
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 scientific publications on our Ampion™ product. 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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