LOS ANGELES, May 24, 2012 (GLOBE NEWSWIRE) -- C3 Jian, Inc., a private company focused on providing improved oral healthcare, announced today that its Investigational New Drug Application (IND) for its novel drug, C16G2, has been accepted by the U.S. Food and Drug Administration (FDA). C3 Jian expects the Phase 1 clinical trial to start in July.
C16G2 is a synthetic peptide derived from C3 Jian's proprietary, pheromone signaling platform technology referred to as STAMPS (Specifically Targeted Antimicrobial Peptides).C16G2 has demonstrated activity selectively targeting Streptococcus mutans, a cavity-causing organism. C3 Jian's STAMP technology has the ability to identify peptide sequences that specifically target most types of bacteria.
Within the IND, C3 Jian submitted the required chemistry, manufacturing and controls information, along with preclinical safety data that supported allowance for human testing in the Company's first Phase 1 clinical trial. The clinical protocol submitted with the IND is entitled "A Phase 1 Dose Escalation Study to Evaluate the Safety, Pharmacokinetics and Microbiology of C16G2 Administered in a Single Oral Dose in Mouth Rinse to Healthy Adult Subjects." This study will enroll up to 36 subjects. The Phase 1 is a single site study to be conducted at New York University, Bluestone Center for Clinical Research. Mark Wolff, DDS, PhD, Professor and Chair of the Department of Cariology and Comprehensive Care at NYU College of Dentistry, will serve as the Principal Investigator of the study.
"The acceptance by the FDA of this IND is a landmark achievement for the Company," said Todd R. Patrick, C3 Jian's President and CEO. "It is recognition of the C16G2 Development Team's hard work, technical excellence, thoroughness and efficiency in preparing for and submitting the essential IND information that makes the difference. We are eager to begin the Phase 1 Clinical Trial for this product candidate while C3J continues to advance other technologies in our pipeline."
The indication identified in the new IND is for the use of C16G2 in preventing dental caries in adults, adolescents and pediatrics. Dental caries, commonly known as tooth decay or a cavity, is rated the most common chronic childhood disease according to the U.S. Surgeon General. In the U.S. alone, over $100 billion is spent annually on oral health expenditures. A majority of these expenses is directly related to dental caries.