Ampio Completes Phase III Clinical Trial for Ampion
By Cyndi Root
Ampio Pharmaceuticals, Inc. announced via press release that its final clinical study on Ampion completed enrolling and dosing. Ampion treats osteoarthritis of-the-knee (OAK). Michael Macaluso, Ampio CEO said, “The Company is on track to complete this final AmpionTM clinical trial within the timeline previously announced.” The company plans to file a Biological License Application (BLA) with the Food and Drug Administration (FDA) soon and begin manufacturing in the summer of 2014.
Osteoarthritis
Osteoarthritis (OA) is a prevalent form of arthritis. The condition occurs when cartilage deteriorates in the joints. Bones rub together, causing discomfort, stiffness, pain, and loss of mobility. Symptoms occur gradually over time and become chronic. Stiff joints, the knee and hips, are usually the first to develop symptoms. The cause of osteoarthritis is not known, but certain risk factors are associated with it. As people get older, they are more at risk. People who overuse their joints, have joint injuries, or weak muscles may be more susceptible. Over 25 million people in the U.S. have some form of OA. OAK involves inflammation in the joint and the soft tissue.
Ampion
Ampion is made from human serum albumin (HAS) and the main ingredient is aspartyl-alanyl diketopiperazine (DA-DKP), a molecule that modulates the immune system. Ampion acts to regulate inflammation by suppressing cytokine production. Included in the preparation are small molecules with anti-inflammatory properties. Ampion is non-steroidal and anti-inflammatory, and it holds promise for a wide range of immune conditions and inflammation-mediated disorders like Crohn’s Disease and pulmonary diseases.
Phase III Trial
The clinical trial is placebo-controlled with 500 participants. Subjects are randomized into two groups. One group received a 4 mL injection of Ampion. The other group received a 4 mL saline dose. Participants are evaluated at 6, 12, and finally at 20 weeks. Researchers will use the WOMACR osteoarthritis index and Patient’s Global Assessment (PGA) of disease severity. Tolerability, safety, and adverse events will be monitored. A small group will undergo Magnetic Resonance Imaging (MRI) and testing of biomarkers.
Biological License Application
The FDA requires companies to request permission to market biological products. The Biologics License Application (BLA) is filed by the sponsor of a product, the manufacturer, or the licensee. The BLA is regulated by interstate commerce rules (21 CFR 601.2).
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