ENGLEWOOD, Colo., May 10, 2016 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) announced today that patient dosing has begun in the initial clinical trial of Ampion™ for the treatment of pain due to osteoarthritis of the hand.
Michael Macaluso, Ampio’s CEO, noted: “The World Health Organization (1) has determined that Osteoarthritis (OA) will be the fourth leading cause of disability world wide by the year 2020. In the United States, the Center for Disease Control (CDC) (2) reports that OA affects 13.9 % of U.S. adults aged 25 years and older and describes their estimate of 26.9 million U.S. adults afflicted in 2005 as conservative.”
Michael Macaluso also stated: “Although Knee OA is a major contributor to this painful medical condition, the 2015 Global Data Epidemiology Forecast (3) reports that Hand OA is more prevalent, projecting that total cases of hand OA in the seven (7) major markets will rise from 151 million in 2014 to 176 million by 2024. As Ampio recently announced the completion of enrollment of our second Pivotal clinical trial for the treatment of Knee OA, we determined that it was an appropriate time to explore whether the anti-inflammatory properties of Ampion™ will provide a benefit to the very significant patient population with Hand OA.”
Dr. David Bar-Or, MD, clarified: “This exploratory trial is a randomized, double-blind, placebo controlled, single center study in one of the largest hand surgery clinics in the USA, to evaluate the efficacy and safety of an intra-articular injection of AMPION™ in adults with pain due to osteoarthritis of the hand, specifically of the first carpo-metacarpal joint of the thumb. Other details of the study are listed at https://clinicaltrials.gov/ct2/show/NCT02762760?term=ampio&rank=1.”
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 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 statements regarding Ampio’s expectations with respect to the Ampion™ second Pivotal clinical trial for the treatment of Knee OA, the Ampion™ Hand OA trial, as well as 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.
Gregory A. Gould
Chief Financial Officer
Phone: (720) 437-6500
- Burden of Major musculoskeletal conditions; Anthony D. Woolf & Bruce Pfleger; Bulletin of the World Health Organization 2003
- GlobalData Osteoarthritis Forecast: http://store.globaldata.com/market-reports/pharmaceuticals-and-healthcare/epicast-report-osteoarthritis-epidemiology-forecast-to-2024