GREENWOOD VILLAGE, Colo., June 30, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that it has started patient enrollment for the MULTIPLE INJECTIONS STUDY using AmpionTM for patients with mostly severe or very severe osteoarthritis (mostly severe Kellgren-Lawrence grade 3 and 4) of the knee for which there is no current non-surgical therapy.
Ampio's CEO, Mike Macaluso, explained, "This study is different from our prior OA clinical trials that were focused on obtaining a Biologics License from the FDA. Those trials were focused primarily on pain reduction using the WOMAC A scale, while the current study will explore the possibility of additional clinical benefits including regeneration of cartilage. The specifics of this new study are as follows:
1) Single Site in the US (N=37)
2) Multiple serial injections, one at baseline, one at 2 weeks and one at 4 weeks
3) The study includes two Phases
- Phase I will analyze safety and, as the study will be open label, no placebo will be used. All patients will receive a 4ml dose of Ampion™ (N=7).
- Phase II will evaluate efficacy, cartilage formation as well as safety and the patients will be randomized 1:1, Ampion™ vs. Saline. This second phase will begin after the Phase I safety data is analyzed. (N=30).
4) Study duration will be 52 weeks in total with each patient committing to 13 total visits to the clinic
5) High resolution MRI analysis will be conducted by a specialized radiologist expert in quantifying cartilage formation. The study requires MRI's at baseline, at week 12, at week 24, and at week 52.
6) Knee aspirations will also be performed at the same time as the MRI's and the synovial fluids will be analyzed by proteomic tools and for specific cartilage regeneration and stem cell biomarkers.
7) Detailed activity and exercise logs will be recorded by the patients, so that positive lifestyle changes will be followed.
"The WOMAC scale which was used to evaluate the efficacy of our prior trials, has a fundamental limitation in that it reports only pain in the prior 48 hours, in and of itself a very subjective measure," continued Mr. Macaluso. "For example, if patients increased their activity levels because AmpionTM reduced their pain (some patients reported significant activity increase in our prior trials) they could have experienced discomfort as a result of the increased activity alone. We have come to consider that AmpionTM may provide more clinical benefit than reduction of pain and this MULTIPLE INJECTIONS STUDY is designed to explore that possibility."
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.
Ampio Pharmaceuticals, Inc.
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