ENGLEWOOD, Colo., March 22, 2017 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE), a leader in the development of Ampion™, a low molecular weight fraction of human serum albumin with anti-inflammatory properties, today announced that it is re-issuing its previous release that was made on March 20, 2017 to incorporate certain disclosures that are required under the NYSE MKT Company Guide Sections 401(h) and 610(b). Included below are these additional disclosures along with the previously disclosed update of corporate activities.
As stated in a press release dated February 27, 2017, having recently concluded a successful series of meetings with the US Food and Drug Administration ("FDA"), Ampio is preparing to initiate what is anticipated to be the final pivotal trial of Ampion™ to treat the severe pain associated with Kellgren-Lawrence grade 4 osteoarthritis of the knee ("OAK"). As recommended by the FDA, the proposed primary endpoint for this study follows OARSI guidance, utilizing the OMERACT-OARSI responder rate. Using this responder rate definition, all previous Ampion™ single injections clinical trials would have successfully met this endpoint. In addition, Ampio plans to advance all necessary Biologic License Application (BLA) activities in parallel to expedite the path to potential FDA approval.
As previously stated in the February 27, 2017, press release, the FDA acknowledged an unmet medical need in patients with pain due to severe OAK, graded as Kellgren-Lawrence Grade 4 (KL 4), where there are currently no FDA-approved treatments for this population.
Also, Ampio is pleased to announce that after an extensive process, the board of directors has selected Locust Walk to serve as a strategic advisor to the company. Locust Walk's charter will be to identify and evaluate potential strategic relationships for Ampion™. Among the many reasons Locust Walk was selected is due to their recent experience in securing transactions for similar stage therapeutics to treat pain as well as extensive knowledge of the OAK market. "I am very excited about Ampio's current position," said Michael Macaluso, Chairman, and CEO. "In the history of the company, we have never been as close to realizing what we believe to be the full potential of Ampion™, both from a regulatory perspective as well as commercial. I am thrilled to be working with Locust Walk to identify the optimal path to unlocking the value of Ampion™ for both patients and shareholders."
Receipt of Audit Opinion with Going Concern Qualification:
As previously disclosed in its Annual Report on Form 10-K for the fiscal year ended December 31, 2016, which was filed with the Securities and Exchange Commission on March 16, 2017, 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, 2016.
Osteoarthritis 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.
About Locust Walk:
Locust Walk is a leading life sciences transaction advisory firm focused on biopharmaceutical and medical technology companies. Our team of experienced professionals fuels the growth of promising companies at every stage by connecting the right products, the right partners and the most attractive sources of capital – driving innovation for growth and transformative results. Locust Walk was founded in 2009 and currently has offices in Boston, San Francisco, Tokyo, Japan and Cologne, Germany. Over the past two years, Locust Walk has completed 19 transactions for its clients around the world. For further information, please visit www.locustwalk.com
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," "proposed," "will," "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, our ability to complete future investor conference calls to discuss the Company's strategies moving forward 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 our proposed small pre-approval study and how the Ampion™ label might be defined and what we will seek for the label to state. 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
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SOURCE Ampio Pharmaceuticals, Inc.