| Mark Cooper M.D. BRTT Project PI, Core Director |
Senior VP of Science and Medical Affairs |
Dr. Cooper co-founded Copernicus Therapeutics in 1995 while a faculty member in the Department of Medicine at Case. Copernicus’ initial non-viral gene transfer, expression, and targeting technologies were in-licensed from Case. After Copernicus secured venture capital funding in 1998, Dr. Cooper left Case to direct the research and clinical development programs at Copernicus. Under his direction, Copernicus developed novel formulation methods and compositions (DNA nanoparticles), established quality control and quality assurance programs, established the gene transfer properties of its technologies in animals, and determined which clinical indications would be a focus of its drug development efforts. These programs have generated two patents assigned to Copernicus and a pending patent that includes claims for compositions, formulation methods, quality control tests, and methods for use in humans (this application is currently split into 5 divisionals). Based on robust lung gene transfer data and a minimal toxicity profile, Copernicus initiated a very successful initial phase I human clinical trial in cystic fibrosis subjects in 2002. Following intranasal application of the DNA therapeutic, no adverse events were attributed to the vector and 8 of 12 subjects had evidence of partial to complete restoration of the CFTR chloride channel (mutations of which cause cystic fibrosis). Aerosols of DNA nanoparticles were recently determined to retain full structural integrity and functional activity, and a phase I lung administration clinical trial in cystic fibrosis subjects is planned in the second quarter of 2005. Dr. Cooper has been directly involved in leading the scientific and drug development programs at Copernicus, overseeing its intellectual property portfolio, and preparing grants, manuscripts, and being the Company spokesperson at scientific meetings. Dr. Cooper co-directs the management of Copernicus along with its President and CEO (Robert Moen, M.D., Ph.D.); these activities include fund-raising, preparation of business plan documents, and strategic planning.
Dr. Cooper has been the principal investigator on several grants that have supported the research and development programs at Copernicus, including a $1.08M Technology Action Fund grant that is supporting current IND-directed aerosol preclinical studies, $0.94M and $1.5M grants from the Cystic Fibrosis Foundation that supported the initial CF clinical trial, 4 prior SBIR awards, and a prior RO1 grant.