Ampio announces positive results on the open label portion of the Multiple injection Study of Ampion™ in patients with osteoarthritis of the knee.
ENGLEWOOD, Colo., Aug. 5, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced the one month 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 injections study involved patients receiving a series of three 4ml injections of Ampion™ intra-articularly (at baseline, 2 weeks and four weeks following the initial visit). In order to proceed with the randomized vehicle- controlled portion of the trial, we had to repeat a demonstration of both safety and efficacy even though efficacy and safety had been demonstrated previously in the single injection SPRING study. No serious drug related adverse events were reported in either trial. The WOMAC A pain score improved by 65% from baseline with the multiple injections at one month post injection (WOMAC A mean improved from 2.2 (0.55) to 0.8(0.62), mean difference 1.43 (0.406), p=0.01) compared to 33% in the SPRING study at the same time point. In addition, the function score WOMAC C compared to baseline improved by 74 % at 4 weeks (WOMAC C mean improved from 2.3(0.55) to 0.6 (0.58), mean difference 1.70(0.374), p=0.004). The study also includes serial high resolution MRI's at various time points that will explore whether there are clinical benefits beyond pain relief."
Mr. Macaluso, Ampio's CEO further noted "With these positive results, Ampio is proceeding with the randomized portion of this study and the first 10 randomized patients were already treated. Given the absence of side effects in the Ampion™ studies, we always thought it likely that physicians would treat their patients with more than the single injection practiced in the "SPRING" and "STEP" clinical trials and look forward to be able to demonstrate the clinical efficacy and safety of this treatment strategy for patients enduring chronic pain with their osteoarthritis. Consequently, we are encouraged, but not surprised, that multiple injections appear to be safe and more effective at pain relief than a single injection. Our team is now in the process of expanding the number of sites and patients participating in this study in order to use these data for expanding our label. Since the multiple injection study is underway, we do not anticipate a delay in our BLA filing, which is expected in the first quarter of 2015" added Macaluso."
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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