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omni bio pharmaceutical inc (OMBP) Key Developments

Omni Bio Pharmaceutical, Inc. Auditor Raises 'Going Concern' Doubt

Omni Bio Pharmaceutical, Inc. filed its 10-K on Jun 16, 2014 for the period ending Mar 31, 2014. In this report its auditor, Hein & Associates LLP, gave an unqualified opinion expressing doubt that the company can continue as a going concern.

Omni Bio Pharmaceutical, Inc. Appoints Bruce D. Forrest as Chief Development Officer

Omni Bio Pharmaceutical, Inc. announced the appointment of Dr. Bruce D. Forrest to the position of Chief Development Officer. Dr. Forrest is currently President of B D Forrest & Company, Inc. Dr. Forrest has been retained over the past 18 months by Omni Bio to assist the company with such services. In his expanded role of Chief Development Officer he will now also oversee implementation of the development plan for Omni Bio's lead Fc fusion recombinant AAT molecule that is being targeted for the treatment of Type 1 diabetes, graft versus host disease and various inflammatory conditions, including chronic gout. Included in this role will be interface and leadership responsibilities for work being performed by recently engaged cell line optimization and product manufacturing partner, Gallus BioPharmaceuticals, Inc. Dr. Forrest has over 25 years of industry experience in pharmaceutical development, including vaccines and biopharmaceuticals. Dr. Forrest was previously Senior Vice President in Vaccines R&D at Wyeth Pharmaceuticals where he was responsible for clinical and development activities for all late phase programs.

Omni Bio Pharmaceutical, Inc. Announces Publication of Its Pilot Study of Alpha-1 Antitrypsin in Type 1 Diabetes

Omni Bio Pharmaceutical, Inc. 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-1 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. 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-1 in monocytes at 12 months among all patients was reduced 3-fold compared to baseline (p < 0.05); Monocyte production of IL-1 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-1 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-1 (p < 0.04 and p < 0.02, respectively); No significant adverse effects were reported in the study.

Gallus BioPharmaceuticals, LLC Enters Cell Line Optimization and Manufacturing Agreement with Omni Bio Pharmaceutical, Inc

Gallus BioPharmaceuticals, LLC and Omni Bio Pharmaceutical, Inc. jointly announced finalization of a multi-stage manufacturing services agreement. The agreement includes cell line optimization, analytical development and manufacturing scale-up activities for Omni Bio's leading AAT Fc fusion protein with the goal of providing cGMP product to support animal toxicology studies and early clinical trials of the molecule. Under the agreement, Omni Bio has selected the commercially available CHOZN(R) GS Cell line as the expression system. In addition, SAFC(R) will perform the cell line development and safety testing services, in conjunction with Gallus' overall management of the process development and manufacturing services program for Omni Bio. 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.

Robert C. Ogden Tenders Resignation as Chief Financial Officer of Omni Bio Pharmaceutical, Inc., Effective March 28, 2014

On March 5, 2014, Robert C. Ogden tendered his resignation as Chief Financial Officer of Omni Bio Pharmaceutical, Inc., effective as of March 28, 2014. Mr. Ogden will continue to serve in his current capacity until the effective date of his resignation.

 

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