SOURCE: Omni Bio Pharmaceutical, Inc.

Omni Bio Pharmaceutical, Inc.

November 20, 2013 09:00 ET

Omni Bio Announces Reduction in Inflammatory Myocardial Injury With Its Lead Recombinant Molecule

Fc-AAT Shown to Be Effective in Mouse Model of Myocardial Ischemia

DENVER, CO--(Marketwired - Nov 20, 2013) - Omni Bio Pharmaceutical, Inc. ("Omni Bio") (OTCBB: OMBP), a biopharmaceutical company focused on the commercialization of new uses of alpha-1 antitrypsin (AAT) for the treatment of a variety of medical indications and the development of recombinant forms of AAT, today announced important results from new studies of its recombinant molecule, Fc-AAT.

Dr. Stefano Toldo, PhD, of the Virginia Commonwealth University Medical Center yesterday presented results on the effects of AAT and Fc-AAT on reduction of myocardial injury in a mouse model at the annual American Heart Association meeting in Dallas, Texas. In an experimental model of acute myocardial infarction, mice underwent a 30 minute left anterior coronary artery occlusion and were then administered, upon reperfusion of the artery, either clinical grade plasma-derived AAT (60 mg/kg), one of two forms of recombinant Fc-AAT (each at 2 mg/kg), or one of three controls: human IgG1 (2 mg/kg), human albumin (60 mg/kg) and NaCl 0.9% (0.2 ml). Results measured at 24 hours showed that Omni Bio's Fc-AAT:

  • Reduced infarct size by nearly 50% relative to each control agent
  • Almost fully prevented reduction of Left Ventricular Ejection Fraction (LVEF), a measure of cardiac contractility
  • Was comparable to the effects of plasma-derived AAT but did so with a 40 times lower dose
  • Was comparable to another recombinant Fc-AAT construct that had been engineered not to have neutrophil elastase inhibitory activity

The study concluded that recombinant Fc-AAT reduces inflammatory myocardial injury following ischemia-reperfusion in the mouse leading to preservation of viable myocardium and systolic function independent of its elastase inhibitory function.

Dr. Antonio Abbate, MD, PhD, and Dr. Benjamin Van Tassell, PharmD, primary investigators in the VCU research team, commented "These results are very exciting and suggest that Fc-AAT has high potential for use in the treatment of acute myocardial infarction. We are now pursuing early clinical trials of AAT in patients suffering from this condition."

Omni Bio's Chief Scientific Officer, Dr. Charles Dinarello, added "Findings such as these continue to validate the broad potential for the use of AAT in several inflammatory conditions and also highlight the potential for our recombinant Fc fusion molecule to be used in a low-dose, self-administered subcutaneous format."

Dr. Bruce Schneider, CEO of Omni Bio, stated "Omni Bio is very pleased to have supported the work performed by the VCU team. We are especially encouraged by the growing evidence for the potential use of our lead Fc-AAT molecule in a variety of treatment settings."

About alpha-1 antitrypsin (AAT)

AAT is the most abundant circulating serine protease inhibitor in the body and an acute phase reactant. Systemic deficiency in AAT due to genetic mutations can result in debilitating liver failure and chronic lung disease such as emphysema. Lifelong treatment with plasma-derived AAT, intravenously administered, is indicated for such patients. Recent evidence suggests that AAT plays an important role in modulating immunity, inflammation and apoptosis. AAT protects various cell types from cell death, inhibits caspases-1 and -3 activity and has been shown to be effective in a wide variety of animal models of human disease, including diabetes, graft versus host disease (rejection reactions following bone marrow or other transplantation procedures), refractory gout, myocardial infarction and inflammatory bowel disease.

About Omni Bio Pharmaceutical, Inc.

Omni Bio Pharmaceutical (www.omnibiopharma.com) is a biopharmaceutical company that is focused on alternative uses for AAT and on developing new recombinant forms that can be applied to the treatment of a broad range of indications as noted above. Since its formation, Omni Bio has supported research using animal models and human clinical studies that demonstrate that AAT is a promising agent for ameliorating these conditions.

Forward-Looking Statements
Some of the statements made in this press release are forward-looking statements that reflect management's current views and expectations with respect to future events. These forward-looking statements are not a guarantee of future events and are subject to a number of risks and uncertainties, many of which are outside our control, which could cause actual events to differ materially from those expressed or implied by the statements. These risks and uncertainties are based on a number of factors, including but not limited to the business risks disclosed in our SEC filings, especially the section entitled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended March 31, 2013. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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