ENGLEWOOD, Colo., March 26, 2019 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that on March 11, 2019, the Company resubmitted a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA) for a confirmatory Phase III clinical trial of its biological drug, Ampion™, for the treatment of patients afflicted with Osteoarthritis of the Knee (OAK).
Mr. Macaluso, Ampio's CEO added, "After a series of interactions with the FDA, we believe we have addressed and answered all questions regarding trial design. The FDA confirmed they would respond to our SPA submission no later than April 25, 2019. The FDA guidance regarding our trial design was in agreement with the advice we received from multiple independent statisticians who analyzed our clinical results of nearly 1,000 KL4 patients. These patients, taken as a group, provided statistically significant results compared to patients receiving the saline control.
"As site recruitment and patient identification for the trial are currently underway, we will provide an update and commence the trial as soon as practicable after the SPA is awarded. The Company believes the anticipated cost of the trial is manageable and within the range of our other OAK trials and we are reviewing all possible financing alternatives including encouraging investors to exercise the outstanding warrants.
"As recently stated in our 10-K, Ampio will focus all our clinical and financial resources on the approval of Ampion. However, we plan to continue seeking a partnership for Optina™."
Receipt of Audit Opinion with Going Concern Qualification
The Company is required under the NYSE MKT Company Guide Sections 401(h) and 610(b) to publish certain disclosures. As previously disclosed in its Annual Report on Form 10-K for the fiscal year ended December 31, 2018, which was filed with the Securities and Exchange Commission on March 18, 2019, the Company's audited financial statements contained a going concern explanatory paragraph in the audit opinion from its independent registered public accounting firm. This announcement does not represent any change or amendment to the Company's financial statements or to its Annual Report on Form 10-K for the fiscal year ended December 31, 2018.
Osteoarthritis (OA) is an incurable and progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. 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 focused on the development of Ampion to treat prevalent inflammatory conditions for which there are limited treatment options.
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 such as the SPA, whether the FDA will approve the same and the timing thereof, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements for any of its products, including Ampion and Optina, 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.
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