Written by Dentistry Today Tuesday, 11 March 2014 14:29
LOS ANGELES, March 7, 2014 (GLOBE NEWSWIRE) -- C3 Jian, Inc., a private company focused on providing improved oral healthcare, announced today that the first Phase 2 Clinical Trial for its novel drug, C16G2, has begun under its U.S. Food and Drug Administration Investigational New Drug (IND) application. The Company's drug targets the specific elimination of Streptococcus mutans, the bacterium believed to be a critical factor in the cause of dental caries or tooth decay. C3 Jian expects this Phase 2 study to be completed in late 2014.
C16G2 is a synthetic peptide derived from C3 Jian's proprietary, pheromone signaling platform technology referred to as STAMPs (Specifically Targeted Antimicrobial Peptides). C16G2 selectively targets 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.
The clinical protocol is a randomized, double-blind, placebo-controlled, four arm, safety and microbiology study in healthy adult subjects. The primary objective of the Phase 2 Clinical Trial is to further build on the safety profile of C16G2 administration in both dental gel and mouth rinse dosages. The study will also focus on targeting antimicrobial activity of these applications by measuring the reduction of Streptococcus mutans, as well as the total bacteria in dental plaque and saliva. With proper safety, the Company expects to extend the Phase 2 program to assess C16G2 in children.
"The advancement of the Phase 2 clinical program for C16G2 is a testament to our development team's talent and the potential of the STAMP technology platform," said Todd R. Patrick, C3 Jian's President and CEO.
The indication targeted for C16G2 is the prevention of dental caries in adults, adolescents and pediatrics. Dental caries, commonly known as tooth decay or cavities, 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.
About C3 Jian, Inc.
C3 Jian is a clinical-stage biotechnology company developing and commercializing novel products to diagnose, treat and prevent diseases related to the human microbiome, with an initial focus on improving oral health. C3 is advancing proprietary targeted solutions, which can offer more selective, efficacious and safer treatment modalities than broad spectrum antibiotics. The Company's platform cell signaling STAMP technology has potential applications to a variety of diseases and disorders particularly related to bacterial and fungal infections. C3 Jian is based in Los Angeles, California. For more information about the company, please visit www.c3-jian.com.