omni bio pharmaceutical inc (OMBP) Key Developments
Omni Bio Pharmaceutical, Inc. Announces Clinical Data for Use of Alpha-1 Antitrypsin in Steroid-Resistant Graft Versus Host Disease
Dec 9 14
Omni Bio Pharmaceutical, Inc. announced the presentation of interim clinical data demonstrating the ability of plasma-derived alpha-1 antitrypsin (AAT) to reduce inflammation and promote healing of damaged tissues in patients with graft-versus-host disease (GvHD), a common and potentially life-threatening complication following bone marrow transplantation. The positive interim results support continued clinical studies of this novel approach to treating GvHD and also highlight the potential value of Omni Bio's novel, recombinant AAT candidate, AAT-Fc, currently in preclinical development. Data from the first seven patients to complete the Phase 1/2 study were presented at the 56th annual meeting of the American Society of Hematology in San Francisco by Omni Bio's academic collaborators from the University of Washington and the Fred Hutchinson Cancer Research Center. Following allogeneic stem cell transplants to treat leukemic malignancies, the patients in the study all developed severe acute GvHD symptoms (severe diarrhea, loss of mucosal lining in the gut) but did not respond satisfactorily to standard of treatment including high dose steroids. The patients then received intravenous doses of plasma-derived AAT every other day for a total of 8 doses (15 days) in an attempt to alleviate their GvHD symptoms. The investigators concluded that the administration of AAT as a safe salvage therapy for gut GvHD is feasible without clinically relevant toxicity. Stool sampling showed a decrease in intestinal AAT clearance and endoscopic evaluation confirmed healing of the bowel mucosa. The overall findings suggest that further evaluation of AAT as treatment for steroid refractory GvHD, or as first line therapy, is warranted.
Omni Bio Pharmaceutical, Inc. Presents at 7th annual Biotech Showcase Conference 2015, Jan-13-2015 03:30 PM
Nov 20 14
Omni Bio Pharmaceutical, Inc. Presents at 7th annual Biotech Showcase Conference 2015, Jan-13-2015 03:30 PM. Venue: Parc 55 Wyndham San, Francisco - Union Square, San Francisco, CA 94102, United States. Speakers: Bruce E. Schneider, Chairman and Chief Executive Officer.
Omni Bio Pharmaceutical, Inc. Announces Presentation of Phase 1/2 Clinical Data for AAT at American Heart Association Scientific Sessions
Nov 19 14
Omni Bio Pharmaceutical, Inc. announced the presentation of Phase 1/2 clinical data for plasma-derived alpha-1 antitrypsin ("p-AAT"), demonstrating its ability to inhibit the inflammatory response in patients with acute ST-elevation myocardial infarction ("STEMI"), the most severe type of heart attack. The data were presented in a poster at the American Heart Association Scientific Sessions 2014, in Chicago. Importantly, these latest clinical findings further highlight the potential value of Omni Bio's first-in-class recombinant AAT candidate, AAT-Fc. STEMI patients are at particularly high risk for developing heart failure due to tissue damage caused by the intense inflammatory response that occurs following acute myocardial infarction. It is well-known that the degree of inflammation at the time of a heart attack is predictive of adverse outcomes including unfavorable cardiac remodeling, heart failure and cardiac death. In the current study, principal investigator Antonio Abbate, M.D., Ph.D., and colleagues at The Virginia Commonwealth University concluded that a single administration of p-AAT significantly inhibited the acute inflammatory response following STEMI, and was associated with a decreased incidence of heart failure over a 12-week follow up period.
Omni Bio Successfully Completes Cell Line Optimization for Novel Recombinant Biologic
Nov 18 14
Omni Bio Pharmaceutical, Inc. announced that its manufacturing partners, Patheon and Sigma-Aldrich Fine Chemicals (SAFC), have successfully identified several high-expression cell lines able to produce Omni Bio's novel recombinant alpha-1 antitrypsin molecule (AAT-Fc) in large enough quantities to be considered commercially viable. This is a highly significant de-risking milestone that enables Omni Bio to move toward IND-enabling toxicology studies with the first and only pharmaceutically feasible recombinant AAT candidate currently in development. Ten candidate cell lines have been selected for further characterization based on their ability to achieve economically attractive AAT-Fc yields. The best performing cell line is expected to move into manufacturing scale-up activities in early 2015 to support further preclinical investigations and early clinical studies. Having achieved the important value inflection point, Omni Bio also announced that it has engaged Destum Partners, Inc. to assist the company in securing a strategic partner for advancement of AAT-Fc. The company's goal is to license rights to develop and commercialize AAT-Fc, and certain other intellectual property, as a means of infusing Omni Bio with non-dilutive capital to fuel ongoing operating activities.
Omni Bio Pharmaceutical, Inc. Presents at EBD Group's Biopharm America 2014 Conference, Sep-23-2014 03:15 PM
Sep 10 14
Omni Bio Pharmaceutical, Inc. Presents at EBD Group's Biopharm America 2014 Conference, Sep-23-2014 03:15 PM. Venue: Boston Marriott Copley Place, 110 Huntington Avenue, Boston, MA 02116, United States. Speakers: Bruce E. Schneider, Chairman and Chief Executive Officer.