Ampio Announces the Presentation of a Publication on Ampion(TM), its Drug Candidate to Address Human Inflammation, at the American Association of Orthopedic Surgery
GREENWOOD VILLAGE, Colo., Oct. 10, 2011 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) (“Ampio” or the “Company”), a company that discovers and develops new uses for previously approved drugs and new molecular entities (“NMEs”), today announced the acceptance for presentation at the American Association of Orthopedic Surgery (AAOS) meeting in February 2012 in San Francisco, CA of a publication describing a study of 22 patients undergoing surgical removal of orthopedic devices in which all the extracted biofilms were found to contain various levels of the low molecular weight diketopiperazine- Ampion(TM) (composed of the cyclic dipeptide of aspartate and alanine).
Ampion(TM) is formed from the cleavage and cyclization of the N- terminal amino acids of human serum albumin in-vivo as a biological compound, as demonstrated by this study. The study authors conclude that Ampion(TM) is an important immune modulator in biofilm formation on orthopedic implants and that its presence in biofilms found on extracted orthopedic devices suggests innate human physiologic mechanisms conferring tolerance to the implanted device possibly correlated to concurrent inflammation/rejection reactions.
This finding is in addition to a previous report presented at the annual Critical Care Medicine (CCM) meeting in San Diego at the beginning of 2011, demonstrating the presence of Ampion(TM) in the extracted biofilms of endotracheal tubes after being removed from intubated patients and possibly contributing to immune tolerance of this foreign material by the human host.
According to Don Wingerter, Ampio CEO, “The importance of this finding relates directly to the regulatory path that Ampio is pursuing for Ampion(TM) (a biological repurposed drug) as additional proof of its formation and presence in human biological samples and to the clinical trial conducted by Ampio for Ampion(TM) injections into knees of patients suffering from osteoarthritis in Australia.”
About the Ampion(TM) in Knee (AIK) Trial
- In this study, Ampion(TM) is injected into the knees of patients with osteoarthritis of the knee in conjunction with standard therapy, including steroids, aiming to demonstrate a reduction in pain and improved range of motion compared to placebo.
- The observation period in this study is only 72 hours, thus results of this trial are anticipated to be available in the short term.
- Ampion(TM) is a patented small molecule with non- steroidal anti-inflammatory and analgesic properties that is naturally produced by humans in response to injury. Because it is present in commercially available human serum albumin which has been given to millions of people over several decades, it can be considered to be a biological.
- Ampion(TM) may qualify as a new use for an existing drug suggesting a shortened regulatory path compared to new drugs because human serum albumin is approved for intravenous administration to patients. For an informative Q & A about Ampion(TM) please click on http://ampiopharma.com/faqs-about-ampion/
“We are very excited that these significant human studies of Ampion(TM) are underway,” stated Dr. David Bar-Or, founder and Chief Scientist. “We already understand a great deal about the mechanisms of action and potential usefulness of Ampion(TM) from our in-vitro studies using human tissue and in-vivo animal studies. There are hundreds of thousands of patients with painful conditions associated with inflammation that need new therapies and Ampion(TM) is a molecule produced by the body that appears to have a significant role in the homeostasis of inflammation. Importantly, it may be used both acutely and chronically, orally, parenterally (by injection), topically or by inhalation. The human origin of Ampion(TM) suggests the possible benefit of few side effects while providing effective relief for many patients whose pain and inflammatory condition is unabated by current medical treatments.
Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for metabolic disease, eye disease, kidney disease, inflammation, CNS disease, and male sexual dysfunction. The product pipeline includes new uses for previously approved drugs and new molecular entities (“NMEs”).
By concentrating on development of new uses for previously approved drugs, approval timelines, costs and risk of clinical failure are reduced because these drugs have strong potential to be safe and effective while their shorter development times can significantly increase near term value. A key strategy includes actively exploring partnership, licensing and other collaboration opportunities to maximize Ampio’s product development programs. For more information about Ampio, please visit our website, www.ampiopharma.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 use of words such as “believe,” “expect,” “plan,” “anticipate,” and similar expressions .These forward-looking statements include risks associated with clinical trials, expected results, regulatory approvals, successful commercialization and marketing of Zertane(TM) and the combination drug in Korea, 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 Ampio’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
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SOURCE Ampio Pharmaceuticals, Inc.