SOURCE: Omni Bio Pharmaceutical, Inc.

Omni Bio Pharmaceutical, Inc.

March 15, 2013 08:00 ET

Omni Bio Announces First Results for Its Lead Recombinant Molecule

Fc-AAT Shown to Be Effective in Mouse Models of Gouty Arthritis

DENVER, CO--(Marketwire - Mar 15, 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 the first disclosure of important results for its recombinant molecule, Fc-AAT.

Leo A. B. Joosten, PhD, of the Radboud University Medical Center, Nijmegen, The Netherlands, presented data on therapeutic applications of Fc-AAT in gout at the 4th European Workshop on Crystals in Human Diseases in Paris, France. Dr. Joosten reported on several studies that he and colleagues performed in mouse models of gouty athritis showing that Fc-AAT:

  • Effectively suppressed pro-inflammmatory responses as measured by cell influx, joint swelling, IL-1β and IL-6 levels in a dose-dependent manner
  • Exhibited a significant reduction (85%) in these parameters at a relatively low dose of 50 µg (2 mg/kg per mouse) that was at least as effective as a high dose (10mg/mouse) of the IL1 receptor antagonist anakinra
  • Was at least 40 times more potent than a clinical grade of plasma-derived AAT
  • Exhibited a prolonged duration of action relative to plasma-derived AAT

The study also concluded that Fc-AAT has a unique mechanism of anti-inflammatory action that occurs through modulation of TLR2 and TLR4 expression, suppression of a variety of pro-inflammatory cytokine mediators, inhibition of capsase-1 activation and induction of IL1 receptor antagonism.

Dr. Joosten commented, "These results are very exciting and suggest that Fc-AAT has high potential for use in the treatment of refractory gout and other inflammatory conditions. We are now considering how best to pursue early clinical trials 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." Presently, treating AAT-deficient patients requires weekly intravenous infusions and travel to a doctor's office or infusion center.

Dr. Bruce Schneider, CEO of Omni Bio, stated, "Omni Bio is very pleased to have supported Dr. Joosten's work and this first important disclosure of data on our lead Fc-AAT molecule. We will continue to foster the research of Fc-AAT to expand our understanding of its utility 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), 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. 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, 2012. 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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