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GREENWOOD VILLAGE, Colo.,
June 3, 2013 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) today announced an update on its clinical progress for Ampion
TM, the sexual dysfunction portfolio, and Luoxis Diagnostics, Inc.
In the SPRING trial, Ampion is being evaluated for its effect on reducing pain in osteoarthritis of the knee, measured by the WOMAC scale, as a single intra-articular injection into the knee in 4 milliliter (mL) and 10 milliliter (mL) volumes as compared to placebo at twelve weeks. The study treated in excess of the targeted 320 patient goal in less than four weeks. This was designed as a run-in to a Phase III pivotal trial, which Ampio will initiate once the optimal volume is determined and the proposed pivotal trial is properly powered to achieve its scientific objectives. By
June 7th, all patients in the SPRING trial will have received the three follow-up phone calls and the six (6) week exam that followed the baseline exam at time of dosing. Clinical results from the completed trial, which includes additional follow-up calls and a final exam, will be made available in the third quarter of 2013. These results will be the basis for corporate strategy and business negotiations going forward.
Optina (danazol) is being tested in a 505(b)(2) trial to treat diabetic macular edema (DME). This may become the pivotal trial as a portion of 505(b)(2) drugs receive FDA registration based on a single clinical trial.
The randomized, placebo-controlled, double-masked, multicenter
United States trial is expected to enroll approximately 450 patients. The primary endpoint is improvement in best-corrected visual acuity (BCVA) compared to placebo. Secondary endpoints are 1) categorical changes in visual acuity (VA) in treated patients compared to placebo; 2) reduction in central macular thickness (CMT) in treated patients compared to placebo; and, 3) safety and tolerability of the two Optina™ doses. Interim four week masked data of approximately 360 patients will be announced in the fourth quarter of 2013. Full twelve week top-line preliminary data will be announced in the first quarter of 2014.
Sexual Dysfunction Portfolio
Ampio is in late-stage negotiations to license Zertane, for treatment of premature ejaculation, and Zertane-ED, for treatment of concomitant premature ejaculation and erectile dysfunction.