Ampio Pharmaceuticals Awarded Canadian Composition of Matter Patent That Strengthens IP Protection for Its Key Drug Ampion™

GREENWOOD VILLAGE, Colo., Dec. 22, 2011 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE - News) ("Ampio" or the "Company"), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), today announced notification of the granting of a Canadian patent with broad claims directed to: "METHOD OF USING DIKETOPIPERAZINES AND COMPOSITION CONTAINING THEM". The protected compositions contain either DA-DKP, a cyclic dipeptide diketopiperazine, which is the active ingredient of Ampion™, but also extend to many other diketopiperizines.

Dr. David Bar-Or, Ampio's Chief Scientific Officer, noted "The patent also includes claims for these compositions that target clinical treatments for inflammation and inflammatory diseases and conditions, such as disease or condition is acute respiratory distress syndrome, an allergy, arthritis, asthma, bronchitis, a cancer, a cardiovascular disease, Crohn's disease, cystic fibrosis, emphysema, endocarditis, gastritis, gastrointestinal ulceration, inflammatory bowel disease, ischemia, ischemia reperfusion, multiple organ dysfunction syndrome, myocardial infarction, a neoplastic disease, nephritis, pain, pancreatitis, psoriasis, a respiratory infection, sepsis, shock or ulcerative colitis."

Dr. Bar-Or further noted "This patent complements the already extensive and robust portfolio of worldwide issued patents for Ampion™. The mechanism of action of Ampion™, an innate human biological small molecular weight compound, is unique as it not only inhibits the early activation of memory T cells but also affects an upstream event in inflammation by tightening vascular permeability among other effects".

"We believe that multiple inflammatory conditions might benefit from this biological drug" added Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, "and the company is currently testing two such indications in clinical trials:

  • The Ampion™-In-Knee (AIK) clinical trial for the treatment of osteoarthritis of the knee being conducted in Australia. This trial was recently expanded to include a direct comparison to steroids and vehicle control and is expected to conclude by the end of this year.
  • The IRB approved, randomized, vehicle-controlled, double-blinded study conducted at Centers for Allergy and Asthma in Denver, Colorado for the treatment of rhinitis. This trial indicated that Ampion ™ provides safe and effective anti-inflammatory relief when administered in nasal spray formulation to patients with nasal inflammation (rhinitis)."

About Ampion™
Ampion™ is a non-steroidal anti-inflammatory drug that appears to have a significant role in the homeostasis of inflammation, so that it has the potential to be used in a broad array of inflammatory conditions which impact millions of patients. Ampion™ is a molecule produced by humans in response to injury and is present in commercial human serum albumin (HSA) preparations. Ampion™ is protected globally by composition of matter and use patents. Because HSA and blood derived products are currently managed by the Center for Biologics Evaluation and Research division of the FDA, Ampio believes this product will be classified as a biologic.

About Ampio Pharmaceuticals
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.

Contact:
Investor Relations

Ampio Pharmaceuticals, Inc.

720-437-6500

SOURCE Ampio Pharmaceuticals, Inc.

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