Ampio Injects First Patients in 2nd Phase III, Pivotal Clinical Trial for Ampion(TM)(The STEP Study) for Its FDA Biological License Application (BLA).
GREENWOOD VILLAGE, Colo., Jan.13, 2014 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced the 500 patient Phase III pivotal trial of Ampion(TM) for the treatment for osteoarthritis of-the-knee (OAK) has received IRB approval and FDA IND clearance and that patients enrollment and treatments have commenced. http://clinicaltrials.gov/ct2/show/NCT02024529?term=ampio&rank=1
Dr. Vaughan Clift, Ampio’s Chief Regulatory Officer, explained “This phase III, final pivotal clinical trial is a randomized, placebo (vehicle control)-controlled, double-blind study in which 500 patients with osteoarthritis (OA) of the knee will be randomized to Ampion(TM )4 ml intra-articular injection or a 4 ml saline vehicle control. Similar to the initial Phase III trial (SPRING study) the Primary end point will be assessed at 12 weeks following a single injection, however we will follow patients for twenty (20) weeks. The clinical effects of treatment on OA pain will be evaluated during clinic visits at 6, 12 and 20 weeks using WOMAC(R) osteoarthritis index and Patient’s Global Assessment (PGA) of disease severity. Patient safety will be monitored by recording adverse events, concomitant medications, physical examination, vital signs and laboratory tests. In addition, a parallel study of a subpopulation of the patients will be subjected to Magnetic Resonance Imaging (MRI) and testing of serum biomarkers to evaluate signs of knee cartilage regeneration. The study will include eight (8) new clinical sites additional to the nine (9) sites previously utilized in the SPRING study.”
Osteoarthritis is the most common form of arthritis, affecting over 27 million people in the United States. It 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 or hip over a lifetime is approximately 46% and 25%, respectively. 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 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.
Investor Contact: Rick Giles, Director of Investor Relations, Ampio Pharmaceuticals, Inc. Direct: (720) 437-6530, Email: email@example.com
SOURCE Ampio Pharmaceuticals, Inc.