GREENWOOD VILLAGE, Colo.,
Nov. 4, 2013 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced positive results from the eight (8) week extension of the twelve (12) week SPRING study (clinicaltrials.gov NCT01839331) of Ampion
™ for the treatment of osteoarthritis of the knee (OAK).
In the Spring trial of 329 patients, statistically significant achievement of primary and key secondary endpoints following a single intra-articular injection into the knee of either 4 or 10 ml of Ampion™ versus the Saline vehicle control were demonstrated at 12 weeks as previously reported:
, Ampio's Chief Regulatory Officer explained: "In the 329 patient
, both the efficacy and safety of the 4 mL and 10 mL doses were equivalent. Both doses were independently statistically significant, therefore Ampio selected 4 mL as the optimal dose for the extended study and followed the 97 patients who were administered either 4 mL Ampion™ or saline vehicle control for an additional 8 weeks. The results of this extended study should be read with the following two points in mind:
- Of the 97 patients in the 4 mL extension cohort, 39 patients had Kellgren-Lawrence grade 3 and 25 had Kellgren-Lawrence grade 4 (66% of total) are considered to have severe osteoarthritis. Kellgren-Lawrence grade 4 patients are usually excluded from clinical trials because of poor or no response to any current therapy. These patients are considered intractable but were included in the Ampion™ Spring study.
- Patients were considered "responders" if they achieved 40% or greater improvement in pain (WOMAC A) and function (WOMAC C) at and over 20 weeks after a single intra-articular injection into the knee.
- At week twenty (20), 50% of patients in the Kellgren-Lawrence grades of 3 and 4 (severe osteoarthritis) had improvement of 40% or more in the WOMAC A pain scale compared to 25% in the vehicle control group (p=0.04)
- In these same grade 3 & 4 patients, there was a statistically significant improvement in pain (WOMAC A) compared to the vehicle control both at week 20 (p=0.02) and over the whole period of 20 weeks (p=0.005).
- Also in these same grade 3 & 4 patients, there was a statistically significant improvement in function (WOMAC C) compared to vehicle control both at week 20 (p=0.05) and over the whole period of 20 weeks (p=0.04)
Dr. Clift continued, "During our
pre-BLA meeting we provided the complete clinical data set to the FDA and discussed possible courses of action leading to the submission of a BLA. We await the FDA's guidance. Future detailed communications of the Spring trial results will be disclosed in professional forums, peer reviewed publications in scientific journals and at specialty conferences.
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.
Director of Investor Relations
Ampio Pharmaceuticals, Inc.
Direct: (720) 437-6530
SOURCE Ampio Pharmaceuticals, Inc.