Ampio Announces Very Positive Results of the Open Label Portion of the Multiple Intra-articular Injections Study of Ampion™ in Patients with Osteoarthritis of the Knee at Week Six of the Trial
ENGLEWOOD, Colo., Aug. 18, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced the 6 weeks results of the open label portion of the multiple injections of Ampion™ into the knees of patients (n=7) with osteoarthritis (OA).
Vaughan Clift, MD, Ampio's Chief Regulatory Officer explained: "This first part of the multiple injection study involved patients receiving a series of three 4ml injections of Ampion™ intra-articularly (at baseline, 2 weeks and four weeks). In order to proceed with the randomized vehicle- controlled portion of the trial, which is now being expanded to multiple sites across the US, we had to demonstrate safety and efficacy of three injections compared to a single injection demonstrated previously in the SPRING study. There were no drug related serious adverse events reported during the first 6 weeks of this current trial."
Dr. Clift added: "The WOMAC A pain score improved by 86 % from baseline in the multiple injections study at 6 weeks following the first injection (WOMAC A mean improved from 2.2 (0.55) at baseline to 0.3(0.34) at week 6, mean difference 1.9 (0.3), p=0.001) compared to about 40% in the SPRING study at the same time point. In addition, the function score WOMAC C compared to baseline improved by 87 % at week 6 (WOMAC C mean improved from 2.3(0.55) to 0.3(0.23), mean difference 2.0(0.26), p=0.0003)."
Dr. John Schwappach, orthopedic surgeon and the Principal Investigator in the Ampion™ multiple injections trial, stated: "The effects of Ampion™ are truly remarkable. I have never seen an injectable drug into the knee with this degree of pain relief and improvement of function. This will change the way we treat patients with osteoarthritis of the knee."
Mr. Macaluso, Ampio's Chairman and CEO, noted: "The results so far are very encouraging. All patients are reporting almost complete resolution of pain at week 6 and major improvement in function. Baseline MRI's and synovial fluid analysis for each patient performed just prior to the start of the injections, will be repeated at week 12 and compared to baseline to explore whether there are additional clinical benefits beyond pain relief and improved function."
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a clinical trial 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 statements regarding Ampio's expectations with respect to the completion, timing and size of the registered direct offering, as well as 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.
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