DENVER, CO--(Marketwire - May 30, 2012) - Omni Bio Pharmaceutical, Inc. ("Omni Bio") (OTCBB: OMBP), a biopharmaceutical company, today announced the most recent results from its human clinical trial in Type 1 diabetes (the "Trial") being conducted by Dr. Peter Gottlieb at the Barbara Davis Center for Childhood Diabetes at the University of Colorado. The purpose of the Trial is a pilot study to test the safety and efficacy of Alpha-1 Antitrypsin (AAT) as a treatment in Type 1 diabetes, commonly referred to as "juvenile diabetes." Patients were subjected to weekly infusions of AAT over an eight-week period and are being evaluated over a two-year period. A total of 12 patients (eight adults and four juveniles) were enrolled and treated with eight weekly infusions of AAT.
The treatment has been very safe and well tolerated by all the study subjects. Of the 12 patients in the Trial, seven had been diagnosed with Type 1 diabetes within one year from initial screening for the Trial. Data for these recently diagnosed patients are considered to be the most significant and relevant in measurement of the endpoints of the Trial. One endpoint of the Trial was to measure C-peptide levels of each patient following AAT therapy. Six months following the initial screening four of the seven patients showed increased C-peptide levels, whereas most Type 1 diabetics progressively lose their ability to produce endogenous insulin, and, therefore, demonstrate progressively decreasing levels of C-peptide. Another endpoint of the Trial was to measure insulin requirements during and following the AAT treatment. Three of the seven patients displayed decreased dependence on insulin during the 3-6 month period following the start of their eight week AAT therapy.
Baxter Healthcare Corporation provided its formulation of AAT - ARALAST NP [Alpha1-Proteinase Inhibitor (Human)] for the Trial. Omni Bio is aware that two similar trials of AAT have been conducted in patients with Type 1 diabetes. One was conducted by Kamada Ltd and a second by the Immune Tolerance Network, a joint effort of the National Institute of Allergy and Infectious Diseases and the Juvenile Diabetes Research Foundation. Kamada Ltd, a manufacturer of its own formulation of AAT, recently reported that "initial results from its Phase I and II clinical trials on a drug to treat juvenile diabetes showed a positive trend."
Dr. James Crapo, Omni Bio's chief executive officer, commented, "We are pleased to announce these important findings and we believe they support the need for additional trials of the use of AAT in the early treatment of Type I diabetes. These pilot trial findings also provide support for our goal to develop a synthetic form of AAT, which we believe could be a therapeutic and cost-effective treatment for recently diagnosed Type 1 diabetics, as well as for other inflammatory diseases."
About Omni Bio
Omni Bio Pharmaceutical (www.omnibiopharma.com) is a biopharmaceutical company that is focused on AAT and on developing new recombinant versions of AAT that can be applied to the treatment of a broad range of inflammatory and immune diseases including Type 1 diabetes, complications due to bone marrow transplantation referred to as graft versus host disease, acute myocardial infarction and inflammatory bowel disease. Since its formation, Omni Bio has supported research in both animal models and in human studies that demonstrate that the human protein Alpha-1 antitrypsin (AAT) has unique and highly potent anti-inflammatory and immune modifying functions.
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, 2011 and the section entitled "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2011. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Baxter and Aralast are registered trademarks of Baxter International Inc.
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