- Published: 01 May 2017
- Written by Editor
Ampio Initiates Pivotal Trial of Ampion ™
ENGLEWOOD, Colo., May 1, 2017 -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) announces initiation of a single injection study to meet the "unmet medical need" of treating the severe pain and loss of function associated with Kellgren-Lawrence (KL) grade 4 osteoarthritis of the knee (OAK) with a primary endpoint that follows the Osteoarthritis Research Society International (OARSI) guidance, utilizing the Outcome Measures in Rheumatology Clincal Trials (OMERACT) OMERACT-OARSI responder rate.
Dr. David Bar-Or, Ampio's Chief Science Officer, clarified, "In compliance with FDA guidance, this trial will be smaller than our prior trials with 171 patients, randomization of 6 to 1 (Ampion™/Saline) on patients with severe OAK, defined radiologically as KL 4 patients.
The 6-1 randomization will preserve blinding and prevent the bias in the assessment that might be associated with an unblinded evaluation; however, only Ampion™ treated patients will be evaluated. This 12-week study will evaluate the responder rate of Ampion™ treated patients as defined by OARSI, which includes pain, function, and patient global assessment (PGA). The outcome of this study will contribute to the label of Ampion™ which may include pain, function, and patient global assessment. Using the OMERACT-OARSI responder rate definition and the analysis proposed in this protocol, all previous Ampion™ single injections clinical trials would have successfully met this endpoint."
Chris Ehrlich, Managing Director and Head of the West Coast office for Locust Walk (http://www.locustwalk.com/), who was recently appointed to assist Ampio with partnering Ampion™, noted, "Ampion™ meets an unmet medical need for a very large and growing patient population, KL 4 OAK patients. With trial initiation underway, Locust Walk looks forward to launching our efforts to fuel the growth of this promising company by connecting them with the right partners."
Mr. Michael Macaluso, Ampio's CEO, further noted, "Ampio plans to advance necessary Biologic License Application (BLA) activities in parallel with this clinical trial to expedite the path to potential FDA approval. We are unaware of any other FDA approved treatments for the less severe form of OAK (KL 2 & KL 3), which have received this broad of labeling. KL 4 patients are suffering from continuous pain, severely restricted activity, and are going to their physicians more frequently seeking relief than KL 2 or KL 3 patients. We are hopeful Ampion™ may prove helpful to these KL 4 patients as it has an excellent safety profile, with no significant side effects, and offers an alternative to knee replacement surgery.
Regulatory Exclusivity and IP protection:
The Company believes that Ampion™, a low molecular weight fraction of human serum albumin with anti-inflammatory properties, will be identified as a "reference product" upon FDA approval of their BLA. Reference products are granted twelve years of exclusivity under the PHS Act, 42 U.S.C. § 262(k)(7). Specifically, FDA is not permitted to approve an application for a biosimilar or interchangeable product until 12 years after the date of the first licensure of the reference product. The existing Ampion™ portfolio has patent coverage in all major jurisdictions throughout the world (U.S., Europe, Australia, Brazil, Canada, China, Eurasia, Hong Kong, India, Indonesia, Israel, Japan, Korea, Mexico, Malaysia, New Zealand, Philippines, Singapore, South Africa) for pharmaceutical compositions and methods of treating a range of conditions. The portfolio includes 125 issued patents and 85 pending applications throughout seven primary patent families having expiration dates that extend to 2035.
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 OA of the knee over a lifetime is approximately 45%. As this disease is associated with aging, obesity, and diabetes, the number of OAK patients will continue to grow. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. OA 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™, as well as those associated with clinical trials, expected results, regulatory approvals, the ability of Ampio to enter into partnering arrangements, the Biological License Application (BLA) 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.
Gregory A. Gould
Chief Financial Officer
Phone: (720) 437-6500