SOURCE: Omni Bio Pharmaceutical, Inc.

Omni Bio Pharmaceutical, Inc.

July 10, 2013 09:00 ET

Omni Bio Announces Support for Clinical Trial of Graft vs Host Disease

University of Michigan Cancer Center Commences Multicenter Trial

DENVER, CO--(Marketwired - Jul 10, 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 its financial support for a clinical trial of AAT for the treatment of complications following bone marrow transplantation, commonly referred to as Graft versus Host Disease ("GvHD").

The multicenter trial is being coordinated by Pavan R. Reddy, MD, co-Director of the Bone Marrow Transplantation and Hematological Malignancy Program, and Associate Professor of Internal Medicine at the University of Michigan. The University of Michigan Cancer Center and the Leukemia and Lymphoma Society (LLS) are providing the majority of the funding for the study. GvHD is a common complication following non-donor-matched stem cell or bone marrow transplantation. Immune cells (white blood cells) in the tissue (the graft) recognize the recipient (the host) as "foreign." The transplanted immune cells then attack the host's body cells. Although high dose steroid therapy is typically given for treatment of GvHD, most patients who are or become non-responsive to such therapy (i.e., are steroid-refractory) will die within one year of diagnosis.

The purpose of the trial will be to estimate the proportion of patients with acute steroid refractory GvHD who respond to AAT at twice weekly doses for four weeks. Secondary objectives include estimation of:

  • the proportion of patients in complete remission without additional therapy at four weeks after the last dose of AAT
  • the incidence of infection during and following treatment
  • survival at six months without the need for additional therapy

Dr. Reddy commented, "Experimental studies by us and others have demonstrated that AAT can mitigate GvHD. We now hope to translate these observations into humans with potentially fatal GvHD in a proof of concept clinical trial. If this works, it will lead to a novel approach for treating severe GvHD in patients that currently have few, if any, options."

Dr. Bruce Schneider, Chief Executive Officer of Omni Bio, stated, "Omni Bio is very pleased to support Dr. Reddy's work and we are hopeful that AAT will play an important role in the treatment of patients suffering from this life-threatening condition."

Omni Bio holds a license to method of use patent applications in the U.S. and Europe for the treatment of GvHD using AAT.

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, GvHD, 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 ("Fc-AAT") 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.

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