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8-K - FORM 8-K - OMNI BIO PHARMACEUTICAL, INC. | c05348e8vk.htm |
EX-10.1 - EXHIBIT 10.1 - OMNI BIO PHARMACEUTICAL, INC. | c05348exv10w1.htm |
Exhibit 99.1
Omni Bio Enters New Multi-Year Research Agreement with University of Colorado Denver
Potential to Support Human Clinical Trial of Alpha-1 Antitrypsin (AAT) in Influenza
Dr. Charles A. Dinarello Co-Awarded Novartis Prize at
XIV International Congress of Immunology
XIV International Congress of Immunology
Denver, CO (August 24, 2010) Omni Bio Pharmaceutical, Inc. (Omni Bio), (OTCBB: OMBP) today
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.
Shapiros laboratory. These studies in Type 1 diabetes and influenza support Omni Bios 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 Bios 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.
Shapiros laboratory together with the published studies conducted by Dr. Eli Lewis at UCD will be
evaluated in Omni Bios 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 (Congress), being held August
23rd through August 26th in Kobe, Japan. The award recognizes Dr. Dinarellos 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.
About Omni Bio Pharmaceutical, Inc.
Omni Bio Pharmaceutical, Inc. (OTCBB: OMBP) is an emerging biopharmaceutical company formed to
acquire, license, and develop novel therapies for medical indications with substantial
commercialization potential. Omni Bios core technology and pipeline are based on issued patents
and patent applications licensed from the University of Colorado Denver (UCD) and a privately
held corporation surrounding the broader therapeutic potential of currently marketed agents. One of
the Companys lead development programs is evaluating an FDA-approved, off-patent drug, Alpha-1
antitrypsin (AAT), for the treatment of Type 1 diabetes. Novel discoveries made at UCD indicate
that AAT has the potential to address a variety of indications in the areas of bacterial and viral
disorders, biohazards, diabetes and transplant rejection.
The Company is led by Acting CEO Dr. Charles Dinarello, Professor of Medicine in the Division of
Infectious Diseases at UCD. Dr. Dinarello is considered a founding father of cytokine biology. For
additional information, please visit www.omnibiopharma.com.
Forward-Looking Statements
Some of the statements made in this press release are forward-looking statements that reflect
managements 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, most notably the section entitled Risk Factors in our Annual Report on Form 10-K for the
fiscal year ended March 31, 2010. We undertake no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts:
Omni Bio Pharmaceutical, Inc.
Edward C. Larkin
Chief Operating Officer
303-867-3415
Edward C. Larkin
Chief Operating Officer
303-867-3415
The Ruth Group
Sara Pellegrino / Ashleigh Barreto (investors)
646-536-7002 / 7028
spellegrino@theruthgroup.com / abarreto@theruthgroup.com
Sara Pellegrino / Ashleigh Barreto (investors)
646-536-7002 / 7028
spellegrino@theruthgroup.com / abarreto@theruthgroup.com