Omni Bio Announces FDA IND Clearance for Alpha-1 Antitrypsin Type 1 Diabetes Clinical Trial
News Jun 10, 2010
Omni Bio Pharmaceutical, Inc.(OMNI), has announced that the Barbara Davis Center for Childhood Diabetes has received IND regulatory clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial evaluating Alpha-1 Antitrypsin (AAT) in Type I diabetics.
Dr. Charles A. Dinarello, Acting Chief Executive Officer of OMNI, stated, “We are pleased to announce IND Clearance for a Phase I/II clinical trial in Type 1 diabetics. Although this is the first time AAT will be evaluated in humans with Type 1 diabetes, AAT already has an excellent safety track record as an FDA-approved biological. We are confident that this outstanding safety profile was a significant factor in the FDA’s IND clearance.”
AAT is an FDA-approved, off-patent drug currently indicated for the treatment of pulmonary emphysema among those with genetic deficiency of AAT. Preclinical studies demonstrate that AAT may be effective in treating a variety of medical disorders. The decision to pursue a clinical trial of AAT in Type 1 diabetics was based on promising animal study data.
Dr. Dinarello further stated, “If AAT’s efficacy in humans is similar to that observed in our animal studies, it could become a method of treatment for qualifying Type 1 diabetics. Despite the prevalence of Type 1 diabetes in the juvenile population, patients and their parents are still waiting for a solution that can stop this debilitating disease in its tracks.”
The Phase I/II clinical trial is being sponsored by OMNI and will be conducted under the auspices of Dr. Peter Gottlieb at the Barbara Davis Center for Childhood Diabetes and other units at the Anschutz Medical Campus of the University of Colorado Denver (“UCD”). OMNI has licensed patent applications related to the method of use of AAT for the treatment of diabetes from the Regents of the University of Colorado and a privately held corporation.
The study protocol provides for AAT administration during an eight-week treatment period in an initial group of 15 diagnosed diabetics, potentially expanding to up to 50 patients. Following the initial AAT administration, enrolled patients will be monitored for two years.
In conjunction with the receipt of the IND clearance, Omni announced today that it has executed an agreement with a body of UCD and the Barbara Davis Center to conduct the clinical trial, which Omni expects to commence during the third quarter of 2010.
Management to Present at Jefferies 2010 Global Life Sciences Conference OMNI’s executive management team is scheduled to present at the Jefferies 2010 Global Life Sciences Conference at the Grand Hyatt Hotel in New York City on June 11, 2010 at 11:30 am EDT.