ENGLEWOOD, Colo., September 29, 2016 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) announced the Company has met with the CBER Division of the FDA to seek guidance on the best path forward to obtain a Biological License for Ampion™ to treat patients suffering from pain caused by severe osteoarthritis of the knee (OAK).
Michael Macaluso, Ampio’s CEO noted, “We are grateful to CBER for their thorough review of our data, which referenced over 1800 patients across multiple trials. We appreciate their thoughtful and helpful guidance. CBER’s guidance included a number of very good options and as a result, we are continuing discussions. As soon as we have further information we will update our shareholders.”
Mr. Macaluso also reported completion of enrollment for AP-011, Study to Evaluate the Safety of a Single Intra-Articular Injection of Ampion™ for Arthritis of the Basal Thumb Joint. https://clinicaltrials.gov/ct2/show/NCT02762760?term=Ampio&rank=1
“The purpose of this initial ‘hand’ study was to ensure that Ampion™ would be well tolerated (safe) when injected into a small joint at the base of the thumb. OA in the basal thumb joint is common, troublesome, and has limited treatment options. We expect to release further information as soon as all patients have completed the trial.”
Osteoarthritis (OA) is a 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 the Ampion™, and the best path forward to obtain a Biological License, as well as risks associated with clinical trials, expected results, regulatory approvals, and changes in business conditions and similar events. These forward-looking statements also include statements regarding our perception of the guidance given to us from CBER related to the number of very good options and our continuing discussions with CBER as well as our expectation to release further information on the “hand” trial. 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 Quarterly Reports on Form 10-Q. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.
Gregory A. Gould
Chief Financial Officer
Phone: (720) 437-6500