A Raleigh-based company started with the help of a $15,000 loan from the North Carolina Biotechnology Center in 2002, BioMarck Pharmaceuticals, has won approval from the U.S. Food and Drug Administration to start a Phase Two clinical trial on its experimental respiratory therapy.
Phase One studies of BIO-11006, an inhaled drug designed to combat the over-secretion of mucus and inflammation, demonstrated the treatment is safe and well tolerated.
In a recently held meeting with Food and Drug Administration officials, BioMarck presented results from the BIO-11006 nonclinical toxicology program and Phase One clinical studies. After review, the Food and Drug Administration concluded the nonclinical and clinical results presented by BioMarck support the conduct of a Phase Two clinical efficacy and safety study in its proposed design.
BioMarck's Phase Two clinical trial of BIO-11006 will be a multicenter, placebo-controlled, double-blind trial involving approximately 160 Chronic Obstructive Pulmonary Disease patients. The primary objective of the study is to demonstrate that BIO-11006 treatment improves lung function in Chronic Obstructive Pulmonary Disease patients.
About BioMarck Pharmaceuticals
The company's technology is based on scientific concepts developed by Kenneth Adler, a professor of cell biology at North Carolina State University. Besides the 2002 Business Development Loan from the Biotechnology Center, the company also landed a $4 million private investment in August 2007.