- Published: 22 September 2015
- Written by Editor
AMPIO Receives Special Protocol Assessment (SPA) from the FDA and Commences Second Phase III pivotal trial of Ampion™
ENGLEWOOD, Colo., Sept. 22, 2015 -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced it has commenced the second Phase III Study of Ampion™ to treat pain and inflammation due to osteoarthritis (OA) of the knee. Details of the clinical trial design are available on our website, www.ampiopharma.com and will also be uploaded to Clinicaltrials.gov.
A Special Protocol Assessment (SPA) is a written agreement between the FDA and the sponsor company (Ampio Pharmaceuticals), which defines the clinical trial end points required for approval and significantly reduces the risk of bringing a drug to market.
"We greatly appreciate the effort by the FDA in reviewing the extensive data and protocols we submitted before granting the SPA," stated Vaughan Clift, MD, Chief Medical Officer. "The Ampion™ drug and control saline were manufactured in our state-of-the-art, cGMP facility in Colorado. Our sites have been carefully chosen and the site personnel and monitors have been thoroughly trained on the protocol and administration of the WOMAC 3.1 pain index. The pre-trial preparation has been extensive."
Michael Macaluso, Ampio's CEO, noted, "We have been awarded multiple patents to protect the formulation of Ampion™. But more importantly, the FDA has required Ampion™ to meet the clinical obligations for a novel biologic, a special designation that comes with 12 years of market exclusivity. Finally, this second pivotal trial is clinically identical to the previously successful Spring Study, which was confirmed by the agency as one of the two pivotal trials required for approval. In our recent communication with the agency confirming the SPA, the FDA wrote: protocol AP-003-B is adequate to serve as a pivotal trial in support of a future BLA. With positive results and an SPA, Ampion™ has a clearly defined path to market."
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.
Forward Looking Statements
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 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™ AP-003-B study, 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 the Special Protocol Assessment (SPA) as well as the classification of Ampion™ as a novel biologic with 12 years exclusivity. 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