Omni Bio Pharmaceutical Announces Publication Of Its Pilot Study Of Alpha-1 Antitrypsin In Type 1 Diabetes

Published: Apr 30, 2014

DENVER, CO--(Marketwired - April 30, 2014) - Omni Bio Pharmaceutical, Inc. ("Omni Bio") (OTCQB: OMBP), a biopharmaceutical company focused on the commercialization of alternative uses of alpha-1 antitrypsin (AAT) for the treatment of a variety of indications and the development of next-generation recombinant forms of AAT, today announced the publication of final results from its pilot study of AAT in patients with recent onset Type 1 diabetes (T1D) in the Journal of Clinical Endocrinology and Metabolism.

The study, which was conducted under the leadership of Dr. Peter Gottlieb at the Barbara Davis Center for Childhood Diabetes, University of Colorado Denver, concluded that AAT may have a beneficial effect on T1D in recently diagnosed patients through the down-modulation of IL-1β and other pro-inflammatory cytokines in the blood cells of treated patients. IL-1b is known to be harmful to insulin-producing cells and plays a role in T1D. The authors further concluded that targeting inflammation with inhibitors of the innate immune system, such as AAT, might represent an efficient therapeutic strategy for disease prevention.

Dr. Gottlieb commented "The clinical effects of AAT on islet cell function are consistent with the early work of other groups and we are very excited to add the additional perspective of the correlation of these effects with reductions in the pro-inflammatory mediator, IL-1β. We and others are now considering how best to pursue further clinical trials in patients suffering from this condition."

Twelve patients with recently diagnosed T1D were enrolled in the study with each receiving 8 consecutive weekly infusions of 80 mg/kg of AAT. Patients were evaluated for effects of therapy on C-peptide levels following a mixed meal glucose tolerance test as a measure of insulin-producing islet cell function, and on proinflammatory cytokine measures of innate immunity over an 18 month period post-dosing. Key findings were as follows:

AAT led to increased or unchanged levels of C-peptide responses in four patients during 18 months' follow up
The total content of TLR4-induced cellular IL-1β in monocytes at 12 months among all patients was reduced 3-fold compared to baseline (p < 0.05)
Monocyte production of IL-1β was reduced from 82% at baseline to 42% at 12 months
Similar reductions were seen using TLR7/8 and TLR3 agonists in monocytes and myeloid dendritic cells (mDCs)
Unexpectedly, the reduction in cellular IL-1β was observed at 9-12 months post-treatment but not in a cohort of untreated diabetics
Improved islet cell function in the four responder patients correlated with the reduced monocytes and mDC production levels of IL-1β (p < 0.04 and p < 0.02, respectively)
No significant adverse effects were reported in the study

Omni Bio's Chief Scientific Officer, Dr. Charles Dinarello, added "Findings such as these continue to validate in humans the broad spectrum of diseases that may be treatable with AAT. Other indications, such as graft versus host disease and acute myocardial infarction, are presently being studied in clinical trials based on the efficacy of AAT in animal models. These studies bode well for the use of our recombinant Fc fusion molecule and its potential to be injected 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. Gottlieb's work which we believe has helped motivate the initiation of placebo-controlled clinical trials in Type 1 diabetic patients now being pursued by two of the plasma-derived AAT product manufacturers. We will continue to support efforts such as these to expand our understanding of AAT's utility in a variety of treatment settings as precursors to the development of our own patent-protected recombinant AAT Fc fusion molecule."

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. 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.