SOURCE: Omni Bio Pharmaceutical, Inc.

Omni Bio Pharmaceutical, Inc.

May 08, 2014 09:00 ET

Omni Bio Announces Grant of New Use Patent in Europe

European Patent Office Allows Claims for Use of Alpha-1 Antitrypsin to Reduce Risk of Non-Organ Transplant Rejection and Graft Versus Host Disease

DENVER, CO--(Marketwired - May 8, 2014) - Omni Bio Pharmaceutical, Inc. ("Omni Bio") (OTCQB: 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 as well as the development of recombinant forms of AAT, today announced that it has received a Grant Notice from the European Patent Office for the use of AAT in reducing the risks of non-organ transplant rejection and graft versus host disease (GvHD) in patients who have received a cornea, bone marrow or pancreatic islet cell transplant. Patent applications covering similar claims have issued in Canada and are under review in the U.S.

Preliminary human and animal studies indicate that AAT may considerably reduce the severity of GvHD, which is one of the key, life threatening complications of mismatched donor and recipient tissues or cells. GvHD can result in significant damage to the recipients' tissues including damage to the liver, gastrointestinal tract, skin and mucosal membranes. The immuno-modulatory effect of AAT may attenuate inflammation by lowering levels of pro-inflammatory mediators such as cytokines, chemokines and proteases that are associated with this severe disease. As the global demand for transplants increases the risks of developing transplant rejection or GvHD are significant. 

Intravenously administered glucocorticoids, such as prednisone, are the standard of care in acute and chronic GvHD. The use of these glucocorticoids is designed to suppress the T-cell-mediated immune response that are directed to host tissues; however, in high doses, this immune-suppression raises the risk of infections and cancer relapse. In addition, more than 50% of patients do not respond well to steroids, and consequently have very low survival rates. 

The issuance of this patent highlights the rationale for another treatment option to reduce the risk of these serious medical conditions and the potential for reduced side effects when compared to an immunosuppressant or other immune modulating agent.

Dr. Bruce Schneider, CEO of Omni Bio, stated, "The allowance of this patent reinforces our premise that AAT may be an effective therapeutic in a variety of medical conditions, including islet cell transplantation, GvHD treatment or prevention, and Type 1 diabetes. We are currently supporting proof of principle clinical trials for the use of AAT in the treatment of steroid-refractory GvHD at the University of Michigan and the Fred Hutchinson Cancer Research Center. We believe our own proprietary recombinant AAT molecule, Fc-AAT, which had a composition of matter patent recently issued in the U.S., will have application to GvHD and other important medical conditions."

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 ( 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. The Company holds licenses to patents and patent applications licensed from the University of Colorado and a privately held company. 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. The Company is now focused on the development of a recombinant AAT Fc fusion molecule as a new biological entity.

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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