DENVER, Feb. 28, 2011 /PRNewswire/ -- (OTC Bulletin Board: OMBP ) 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 Bio's 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 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