GREENWOOD VILLAGE, Colo.
, Feb. 4, 2014
/PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) ("Ampio" or the "Company") today announced that the article reporting the results of its initial pivotal clinical trial of Ampion for the treatment of pain due to Osteoarthritis of the knee (OAK), was published in PLOS ONE
, an international, rigorously peer-reviewed, open-access, online publication which covers primary research from any discipline within science and medicine, and is the largest (by volume) scientific journal in the world.
The article entitled: "A Randomized Clinical Trial to Evaluate Two Doses of an Intra-Articular Injection of LMWF-5A in Adults With Pain Due to Osteoarthritis of the Knee" details the successful efficacy and safety outcomes of the use of Ampion in a double blinded, placebo controlled randomized trial known as the SPRING study (clinicaltrials.gov NCT01839331).
In the SPRING study, a total of 329 patients were randomized and received treatment across 9 sites in the United States in order to investigate the safety and efficacy of two doses of a single IA knee injection of Ampion on joint pain in OA of the knee. Ampio announced on August 14, 2013 that the SPRING study met its primary and key secondary endpoints, including clinically and statistically significant reductions in pain at 12 weeks in patients treated with Ampion compared to saline vehicle control.
The recently published study concludes that Ampion is safe and effective at providing relief for the pain of moderate to severe OA of the knee over 12 weeks when administered by intra-articular injection into the knee. This study represents a potential major breakthrough in identifying a treatment for pain due to moderate to severe OA, particularly in patients with severe osteoarthritis where no other safe and effective therapies exists prior to joint replacement.
The PLOS ONE article can be found online at : http://dx.plos.org/10.1371/journal.pone.0087910
"These data published in an internationally recognized and prominent scientific journal, PLOS ONE, increase the body of scientific knowledge of treatments for Osteoarthritis, a debilitating condition affecting over 27 million Americans, for which there are currently no efficacious therapies that combine both analgesic and anti-inflammatory effects without side effects," said David Bar-Or, MD, Chief Scientific Officer of Ampio Pharmaceuticals, Inc and lead study author.
Michael Macaluso, Chairman and Chief Executive Officer, noted, "The publication of these findings also adds to the momentum towards commercialization of Ampion. On January 13, 2014, the company announced recruitment of patients in the second and final pivotal trial, the STEP study (clinicaltrials.gov NCT02024529)."
Ampion, also known as aspartyl-alanyl diketopiperazine or DA-DKP, is an endogenous immunomodulatory molecule derived from the N-terminus of human serum albumin (HSA). It appears to have a significant role in the homeostasis of inflammation. DA-DKP is believed to reduce inflammation by suppressing pro-inflammatory cytokine production in T-cells. The non-steroidal, low molecular weight, anti-inflammatory biologic has the potential to be used in a wide variety of acute and chronic inflammatory conditions as well as immune-mediated diseases. Ampio is currently developing this drug as an intra-articular injection for the treatment of osteoarthritis of the knee.
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 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 completion, timing and size of the registered direct offering, as well as risks associated with clinical trials, expected results, regulatory approvals, and changes in business conditions and similar events. 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.
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SOURCE Ampio Pharmaceuticals, Inc.