Omni Bio Pharmaceutical, Inc. announced that it has executed a two-year contract with the University of Colorado Denver (UCD)-Anschutz Medical Campus, in collaboration with researchers at National Jewish Health, to further evaluate the biological activity of Alpha-1 antitrypsin (AAT) and its effects on influenza. Omni Bio will pay UCD approximately $440,000 under the agreement.
Under the agreement, Dr. Leland Shapiro, principal investigator for the study at UCD, will supervise a preclinical study to support previous animal studies of AAT in influenza infection. Pending positive study results, Omni Bio may submit an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate clinical trials of AAT and its effects on influenza patients.
Dr. Shapiro stated, “In preclinical studies, AAT has demonstrated the potential inhibition of several medical disorders, including influenza. Given its broad therapeutic potential, AAT may be able to inhibit a variety of influenza infections, including seasonal, bird and swine related influenzas. While vaccines on the market and in development are primarily for prophylactic use in healthy individuals to prevent influenza infection, AAT may effectively inhibit influenza symptoms in infected patients who require immediate treatment. Omni Bio and UCD have arranged this agreement to achieve proof-of-concept and support prior animal studies in which AAT demonstrated efficacy in arresting and/or preventing influenza infection. We are hopeful that positive results from this study will enable us to file an IND with the FDA to perform a human clinical trial of AAT in patients who have contracted severe forms of influenza, such as H1N1, or bird flu.”
Dr. Charles Dinarello, Acting CEO of Omni Bio, commented, “Following recent IND clearance from the FDA for a Phase I/II clinical trial of AAT in Type 1 diabetics, we are looking forward in continuing investigational work on influenza infection and treatment strategies investigated in Dr. Shapiro’s laboratory. These studies in Type 1 diabetes and influenza support Omni Bio’s objective to study the effects of AAT for multiple unmet medical needs where it has already demonstrated preclinical efficacy. Dr. Shapiro has pioneered a field of innovative alternative therapeutic uses for AAT. His findings have directly contributed to Omni Bio’s development strategy for AAT, and his prior evaluations in influenza animal models will contribute significantly to these studies.” Dr. Dinarello further added, “The earlier research from Dr. Shapiro’s laboratory together with the published studies conducted by Dr. Eli Lewis at UCD will be evaluated in Omni Bio’s previously announced clinical trial of AAT therapy in patients with newly developed Type 1 diabetes. This clinical trial is expected to commence in September 2010.”
Novartis Prize
Omni Bio is also pleased to announce that Dr. Dinarello has been co-awarded the Novartis Prize in clinical immunology at the XIV International Congress of Immunology, being held August 23rd through August 26th in Kobe, Japan. The award recognizes Dr. Dinarello’s work in the discovery, biology, and regulation of Interleukin-1 (IL-1) beta and the use of IL-1 beta antagonists to effectively treat certain inflammatory diseases. On August 25th at the Congress, Dr. Dinarello will give a master speaker presentation, “IL-1 Beta and the spectrum of auto-inflammatory diseases.” The Novartis Prize is the fourth major scientific prize awarded to Dr. Dinarello in the past 18 months.
Date: August 24, 2010
Source: Omni Bio Pharmaceutical, Inc.
