Ampio Clinical, Regulatory and Corporate Update
ENGLEWOOD, Colo., May 22, 2019 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced updates on subjects of interest to shareholders. Clinical: The results of the AP-003-C open label extension study outlining the safety and efficacy of repeat injections of Ampion™ in patients with severe osteoarthritis-of-the-knee (OAK) have been accepted as a podium presentation at the 83rd Annual Meeting of the Western Orthopedic Association (WOA) in Monterey, CA., held from July 31st to August 3rd, 2019. The WOA meeting was developed primarily for orthopedic and trauma surgeons and allied health professionals. The WOA Committee selected multiple research papers and invited nationally respected speakers to present practice-related techniques and findings in orthopedic surgery that cover a variety of specialty orthopedic disciplines and advances in treatment. The Ampion study is entitled "Investigating Repeated Intra-Articular Injections of The Anti-Inflammatory Compound LMWF-5A (Ampion) In Adults with Severe Osteoarthritis: An Open-Label Extension Study" and will be presented by orthopedic surgeon, John Schwappach, MD. on August 3, 2019. Dr. Schwappach summarized the findings: "The purpose of the open label extension study was to evaluate repeat dosing of Ampion every 12 weeks for 52 weeks for safety, efficacy, and structural changes to the joint. The study reported that repeated injections of Ampion are safe and well tolerated, and patients can expect a consistent, beneficial effect with repeat injections. Importantly, there was an improvement in joint space thickness of 12% in the medial compartment for subjects with medial disease, and an improvement of 6% in the lateral compartment for subjects with lateral disease. These in vivo measurements of space, occupied by cartilage in a healthy knee, along with available in vitro data are highly suggestive of Ampion being a safe and effective disease-modifying drug for OAK (DMOAD)." Regulatory: Ampio Pharmaceuticals has been in contact with the U.S. Food and Drug Administration (FDA) regarding the Special Protocol Assessment (SPA) following its re-submission of a revised protocol for AP-013, which the Company believes implements all of the Agency's recommendations provided since the beginning of the SPA review cycle. The Agency confirmed that it would make every effort to expedite this review, however due to a heavy workload, they were not able to commit to providing a response to the Company's SPA re-submission earlier than the 45-day window outlined in the Guidance for Industry Special Protocol Assessment, leading the Company to expect the response will be in mid-June rather than late May 2019, as previously predicted. Corporate: Ampio Pharmaceuticals has engaged Squire Patton Boggs (US) LLP (SPB) as legal counsel for the Company. SPB is a full-service global law firm featuring a multidisciplinary team of over 1,500 lawyers in 47 offices across 20 countries. https://www.squirepattonboggs.com Ampio Pharmaceuticals has also commenced a process to review its appointment of its independent audit firm and has commenced a search to evaluate its options. If the Company were to appoint a new independent audit firm, it would expect to onboard that firm by the end of the second quarter. Plante Moran has agreed to assist with the search process and with any resulting transition. About Osteoarthritis About Ampio Pharmaceuticals, Inc. Forward-Looking Statements Company Contact
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Company Codes: AMEX:AMPE |