The lead pharmaceutical product, NTCD-M3, incorporating this technology has already completed Phase 1 and 2 Clinical Trials, has FDA Fast Track approval, and is expected to be eligible for Breakthrough Therapy Designation by the FDA for a Phase 3 Clinical Trial and to be eligible for Reference Product Exclusivity for 12 years for an approved biologics license application. The exclusive licensee would be responsible for manufacturing, continuing development, obtaining pivotal trial regulatory approval in the US and Europe, marketing and selling of the pharmaceutical products. Phase 2 trial has shown that Dr. Gerding’s invention and treatment, NTCD-M3, is effective in significantly reducing the recurrence of C. difficile infection from 30 percent for placebo to 5 percent for the most favorable NTCD-M3 dosage.
CDC reports that C. diff, a highly infectious bacterium, is the most common microbial-cause of healthcare associated infections in the U.S. and can cause symptoms ranging from diarrhea to severe colitis to death, particularly in older patients. It occurs after use of antibiotic treatment and in the US affects over half million people a year including recurrences. It results in up to $5.9 billion per year in excess health care costs. Reducing its occurrence is a national priority for the Centers for Medicare and Medicaid Services.
Dale Gerding, MD, MACP, FIDSA, FSHEA, is the Chief Medical Officer at a clinical stage biotechnology company and currently a Professor of Medicine in the Division of Infectious Diseases at Loyola University Chicago Stritch School of Medicine and Research Physician at Hines Veterans Administration Hospital. He has been a Merit Review funded research investigator in the VA for over 35 years and is the author of over 300 peer-reviewed journal publications.
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