http://www.omnibiopharma.com/ () —
Omni Bio Pharmaceutical, Inc. ("Omni Bio") (OTCBB: OMBP) today
announced that the first patient has been infused in its FDA-cleared
Phase I/II human clinical trial of Alpha-1 antitrypsin ("AAT") in
recently diagnosed Type 1 diabetics at the Barbara Davis Center for
Childhood Diabetes at the University of Colorado Denver Anschutz
Medical Campus.
The Phase I/II clinical trial is evaluating the potential of AAT to
halt or reduce the deterioration of islet beta cells that causes Type
1 diabetes. While Type 1 diabetics will experience islet beta cell
destruction, the trial evaluates whether AAT treatment may help stop
the course of disease in newly diagnosed diabetics who may have
remaining islet beta cells.
AAT is an FDA-approved, off-patent drug with an almost 20-year safety
track record as an approved treatment in the approximately $400
million market for emphysema in AAT deficient patients. Omni Bio
believes that the market opportunity for the use of AAT in treating
Type 1 diabetes may exceed the current market.
Dr. Charles A. Dinarello, Acting Chief Executive Officer of Omni Bio,
stated, "Following promising preclinical evidence of AAT in Type 1
diabetes, we filed with the FDA to move right into a Phase I/II
clinical trial in newly diagnosed Type 1 diabetic patients. We are
encouraged by the agency's clearance to advance from the preclinical
stage into actual patients, and the initial patient infusion is a
major milestone for Omni Bio. If AAT is effective in disrupting the
deterioration of the islet beta cells, we believe that we may be able
to expedite our time to market in Type 1 diabetes, given the
significance of the unmet medical need and the supportive safety track
record of AAT in its currently approved indication."
Dr. Dinarello continued, "Type 1 diabetes is a large and attractive
market for Omni Bio, and we believe that our method of use patent
applications surrounding AAT further position us to capitalize on this
opportunity to deliver shareholder value while improving treatment for
up to 20,000 Type 1 diabetics diagnosed in the U.S. each year."
About the Phase I/II TrialThe FDA-cleared Phase I/II human clinical
trial of AAT in recently diagnosed Type 1 diabetics is underway at the
Barbara Davis Center for Childhood Diabetes at the University of
Colorado Denver Anschutz Medical Campus. Patients will receive an
eight-week treatment course of AAT infusions, followed by two years of
monitoring. Targeted enrollment is initially 15 patients, and may be
expanded to up to 50 patients pending positive data in critical
measurements.
About AAT in Type 1 DiabetesType 1 diabetes is an autoimmune disease
in which the immune system attacks insulin-producing beta cells in the
pancreas, which are necessary for the body to maintain proper blood
glucose levels. Not all beta cells are typically destroyed at the time
of diagnosis, and between 15-40% remain healthy and able to produce
insulin. Preserving these remaining beta cells is the goal of AAT
therapy in Type 1 diabetics, as their ability to naturally produce
even small amounts of insulin can improve blood sugar control,
simplify daily management of diabetes, and reduce the risk of long
term complications.
About Omni Bio Pharmaceutical, Inc.Omni Bio Pharmaceutical, Inc.
(www.omnibiopharma.com (http://www.omnibiopharma.com) ) is an emerging
biopharmaceutical company formed to acquire, license, and develop
existing therapies for indications with substantial commercialization
potential. Omni Bio's core technology and pipeline are based on issued
and pending patents licensed from the University of Colorado Denver
("UCD") and a privately held corporation surrounding the broader
therapeutic potential of currently marketed therapies. One of Omni
Bio's lead development programs is evaluating an FDA-approved,
off-patent drug, 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.
Omni Bio 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
(http://www.omnibiopharma.com/) .
Forward-LookingStatementsSome of the statements made in this press
release are forward-looking statements that reflect management's
current views and expectations with respect to future events,
including the clinical trial. 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, especially 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.