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Ampio Pharmaceuticals, Inc. Message Board

  • arbtrdr arbtrdr May 4, 2013 11:17 AM Flag

    Updates on all trials - published by AMPE - Ampion

    Suggest all go to the latest SEC quarterly filing. A very clear synopsis of exactly where AMPE stands with all trails is part of the SEC filing.

    Racavalli - The current trail is actually a phase II trial. You are technically wrong. But it is only for dosing with the phase III trial already approved. 10Q report follows:

    Ampion for Osteoarthritis of the Knee

    In December 2012, we submitted an IND to the FDA for the Phase 3 pivotal trial based upon the guidance received at the pre-IND meeting with the FDA in May 2012. Our prior IND submission and FDA guidance suggested we would complete two Phase 3 studies (AP-003 and AP-004) with respect to Ampion�, each enrolling approximately 800 patients. In February 2013, we received new formal guidance from the FDA indicating that the Company should conduct a dose ranging study "as a Phase 2 dose-escalation study or as a run-in study for one of the Phase 3 studies." Accordingly, we submitted an updated trial protocol to the FDA and they approved it in late March. Known as the SPRING trial, Ampion is being evaluated for its effect on reducing pain 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 enrolled in excess of the targeted 320 patient goal. The study was designed as a run-in to a Phase 3 pivotal trial which we will initiate once the optimal volume is determined and the proposed pivotal trial is properly powered to achieve its scientific objectives. Twelve week primary endpoint data are expected in the third quarter of 2013. We also modified our contract with our own Ampion clinical research organization (Ampion CRO) to reflect the revised IND. The contract total is approximately $2.5 million and is expected to be paid over the course of the next eight months, subject to the achievement by the Ampion CRO of specified milestones.


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