| Ampio Announces Results of the Open Label Portion of the Multiple Intra-articular Injections (STRUT) Study of Ampion(TM) in Patients with Osteoarthritis of the Knee at Week Twenty of the Trial | ENGLEWOOD, Colo., Dec. 1, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced updates for the STRUT open label portion (n=7) of the multiple injection study at week 20 of the study.
The seven (7) patient 'open label' phase of the 47 patient STRUT study was performed to assure that multiple injections of Ampion(TM) were safe. Each patient received three 4ml intra-articular injections of Ampion(TM), one at baseline, the second at 2 weeks and the third at 4 weeks. There were no drug related serious adverse events reported during the first 20 weeks of this current trial; the further results of this open label phase are as follows:
-- WOMAC A: The primary endpoint, WOMAC A pain score, improved by 91.2% from baseline to 20 weeks. The WOMAC A mean (SD) significantly improved from 2.27 (0.59) at baseline, to 0.20 (0.23) at week 20, mean difference (95% CI) -2.03 (-2.83,-1.23), p=0.001. -- WOMAC B: The secondary endpoint measurement of stiffness, also improved significantly by 87% from baseline at week 20 from mean (SD) of 2.75 (0.82) to 0.36 (0.48), mean difference (95% CI) --2.33 (-3.51,-1.15) p=0.004. -- WOMAC C: The secondary endpoint of a validated measure of simple daily physical functions improved by 91.3% from baseline at week 20 .This improvement was statistically significant, going from 2.32 (0.60) at baseline to 0.20 (0.34) at week 20; mean (95% CI) improvement of --2.09 (-2.96,-1.21), p=0.002.
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.
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