Healthcare Industry News: U.S. Food and Drug Administration
News Release - December 13, 2018
Ampio Updates Regulatory Status for AmpionENGLEWOOD, Colo., Dec. 13, 2018 -- (Healthcare Sales & Marketing Network) -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today updates the regulatory status of Ampion.
As announced on November 26, 2018, statisticians representing Ampio and the U.S. Food and Drug Administration (FDA) were to meet and discuss the clinical pathway of Ampion™, the company's lead drug, for the treatment of severe osteoarthritis of the knee (OAK) followed by an additional, internal meeting that included reviewers from the FDA Office of Tissue and Advanced Therapies (OTAT). That meeting has taken place and OTAT has, on the afternoon of December 12th, provided final guidance that Ampio should complete an additional trial of KL4 osteoarthritis patients with concurrent controls that would be carried out under a Special Protocol Assessment (SPA) to obtain FDA concurrence on the trial design. Under the guidance of statistician Dr. Jason Connor, President of ConfluenceStat LLC, a trial of approximately 150 KL4 patients, half in the treatment arm and half in the control arm has been designed, and Ampio will be filing the SPA submission in the near future. The trial is designed to expand by 150 patients (300 total patients) if necessary.
Osteoarthritis (OA) is an incurable and progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. The incidence of developing osteoarthritis of the knee over a lifetime is approximately 45%. As this disease is associated with age, obesity, and diabetes, this number will continue to grow. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. Osteoarthritis is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development 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.
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 the 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 Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions including the timing thereof, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties. 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 other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.
Source: Ampio Pharmaceuticals
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