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8-K - FORM 8-K - OMNI BIO PHARMACEUTICAL, INC. | c13296e8vk.htm |
Exhibit 99.1
Omni Bio Pharmaceutical Intends to Expand Type 1 Diabetes Trial to 50
Patients
Patients
Receives Letters of Intent for New Human Trials Expanding Testing of AAT
in Transplantation, Graft vs. Host Disease, Late Stage Type 1 Diabetes and
Type 2 Diabetes
in Transplantation, Graft vs. Host Disease, Late Stage Type 1 Diabetes and
Type 2 Diabetes
DENVER,
Feb. 28, 2011 /PRNewswire/ (OTC Bulletin Board: OMBP.ob
-News) Omni Bio Pharmaceutical,
Inc. (Omni Bio), an emerging biopharmaceutical company formed to acquire, license, and develop
existing therapies for indications with substantial commercialization potential, has committed to
expand its Phase I/II human clinical trial in recently diagnosed Type 1 diabetes patients from 15
patients to 50.
The expansion of the trial population has been approved by the FDA. The trial, which is currently
underway at the Barbara Davis Center for Childhood Diabetes (BDC) at the University of
Colorado-Denver Anschutz Medical Campus, has seen improvement in the condition of the first
enrolled patients. Based on observations of the first enrolled patients at BDC, Omni Bio intends
to expand the patient enrollment to 50 patients, which may involve obtaining a second trial site.
Dr. James Crapo Omni Bios Chief Executive Officer stated, We are currently engaged in discussions
related to expanding our Type 1 diabetes trial from the initially targeted 15 patients to a total
of 50 patients. The expansion of the trial will cause a substantially greater amount of
statistically relevant scientific data to be generated, allowing us to better assess our next steps
in pursuing this indication.
The expansion of the clinical trial would result in an increase of clinical trial service costs of
approximately $2 million, excluding drug costs, and would require Omni Bio to raise additional
financing before the expansion of the trial can begin. There is no assurance that Omni Bio will be
able to raise additional capital to fund the expansion of the clinical trial on acceptable terms or
at all.
Omni Bio Receives Letters of Intent for New Human Clinical Trials in Graft vs. Host Disease, Type 1
and 2 Diabetes and Transplant Rejection
Omni Bio is also pleased to announce that it has received letters of intent for human clinical
trials at a number of institutions in the United States and Europe, contingent upon receipt of
required regulatory approval and adequate financing.
Dr. Charles Dinarello, Omni Bios Director of Medical Affairs and Chief Scientific Officer
commented, Whereas we are well into the infusion stage on our first human clinical trial of
Alpha-1 antitrypsin (AAT) in Type 1 diabetes, it is essential that we establish the foundation
for pursuing the commercialization of other significant areas of our intellectual property. Over
the past six months, we have initiated discussions and provided data to leading researchers and
international investigators related to our intellectual property, and are pleased to advise our
shareholders that we are planning substantive programs to investigate and prove AATs effectiveness
in treating additional disease classifications. Dr. Crapo further added, Dr. Dinarellos own
work and that of his collaborators in the fields of transplantation and GVHD are widely recognized
and offer Omni Bio potential new and large markets for AAT alternative use. While in Europe over
the past several months, Charles has devoted considerable time in building key strategic
relationships for Omni Bio with internationally-renowned scientists.
There is no assurance that the letters of intent will lead to the commencement of actual trials or
that Omni Bio will receive regulatory approvals or be able to raise additional capital on
acceptable terms or at all.
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Letters of intent for human clinical trials
| The treatment of Graft vs. Host Disease in bone marrow transplant patients. Proposed
Trial Site: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan.
Principal Investigator: Pavan Reddy, MD, Associate Professor of Internal Medicine,
Co-Director, BMT Leukemia/Lymphoma. |
||
| Two separate human clinical trials for the treatment of transplant rejection in kidney
transplant recipients. Proposed Trial Site: Radboud University, Nijmegen Medical Center,
the Netherlands. Principal Investigator: Luuk B. Hilbrands, MD, Professor of Clinical and
Experimental Renal Transplantation. |
||
| The initiation of a late stage Type 1 diabetes trial. Proposed Trial Site: University
of Basel, University Hospital-Basel, Basel, Switzerland. Principal Investigator, Dr. Marc
Donath, Professor of Endocrinology, Head of Clinic of Endocrinology, Diabetes & Metabolism. |
| The initiation of a trial in Type 2 diabetics that are not responding to currently
available forms of therapy and are at risk of severe cardiovascular complications.
Proposed Trial Site: University of Basel, University Hospital-Basel, Basel, Switzerland.
Principal Investigator, Marc Donath, MD. |
About Omni Bio Pharmaceutical, Inc.
Omni Bio Pharmaceutical, Inc. (www.omnibiopharma.com) is an emerging biopharmaceutical company
formed to acquire, license, and develop existing therapies for indications with substantial
commercialization potential. Omni Bios 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 Bios 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. 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, including the expansion
and commencement of clinical trials and the outcome and expenses of such trials. 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 receipt of adequate funding to
expand and commence clinical trials; receipt of applicable regulatory approvals for clinical
trials, the risks related to the ownership and enforceability of our licensed intellectual property
necessary to conduct the clinical trials and 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.
Omni Bio Pharmaceutical, Inc.
|
Hayden IR | |
Edward C. Larkin, Chief Operating Officer
|
Brett Maas, Managing Partner | |
(720) 488-4708
|
(646) 536-7331 | |
Email: brett@haydenir.com or | ||
Cameron Donahue, Partner | ||
(651) 653-1854 | ||
Email: cameron@haydenir.com |
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