Tuesday May 10, 2016 0 comments
ENGLEWOOD -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced patient dosing has begun in the initial clinical trial of Ampion™ for the treatment of pain due to osteoarthritis of the hand.
"The World Health Organization has determined that Osteoarthritis (OA) will be the fourth leading cause of disability world-wide by the year 2020,” said Michael Macaluso, Ampio CEO.
“In the United States, the Center for Disease Control (CDC) 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.
"Although Knee OA is a major contributor to this painful medical condition, the 2015 Global Data Epidemiology Forecast reports that Hand OA is more prevalent, projecting that total cases of hand OA in the seven 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."
"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,” said Dr. David Bar-Or.
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.