P113 is a 12 amino-acid antimicrobial peptide derived from a naturally occurring histatin protein found in human saliva. Histatin proteins play an important role in the human body’s natural defence against oral diseases including oral cavity, oral candidiasis and esophagus infection among others. The initial scientific concept of P113 was based on research studies conducted by its inventor, Professor Frank Oppenheim, at Boston University. Demegen, Inc. then licensed the P113 technology from Boston University and completed Phase I and Phase II clinical studies on P113 for the treatment of gingivitis. Results from the clinical studies suggested P113 was safe and effective in the treatment of gingivitis. In February 2005, the Company obtained its right to the P113 technology through a license arrangement with Demegen Inc.
Pursuant to the license arrangement between Pacgen and Demegen, the Company has an exclusive worldwide right to develop and commercialize prescription and non-prescription pharmaceutical products containing P113 or one or more related peptides for the treatment of any oral condition (excluding transitional skin-mucous membrane areas), as well as vaginal, dermatological and ophthalmic conditions.
The Company developed P113 as a mouthrinse formulation for the topical treatment of oral candidiasis until 2008. Oral candidiasis, or thrush, is usually seen as a secondary consequence arising from one of a number of primary or underlying medical conditions including HIV/AIDS, cancer, diabetes, asthma and xerostomia (abnormal dryness of the mouth). The Company completed formulation optimization studies, a Phase I/II proof of concept clinical study, as well as a Phase IIb dose-ranging study. Data from Pacgen’s clinical studies demonstrated that P113 was effective in the treatment of oral candidiasis. The data also suggested that P113 compared favourably to the efficacy demonstrated by Nystatin, one of standard of treatments for oral candidiasis.
In January 2014, the Company sublicensed its P113 right to its major shareholder General Biologicals Corporation (“GBC”). By the end of 2015, GBC has successfully launched P113 non-prescription over-the-counter products to the market, focusing on the ORAL HEALTH CARE, FEMININE CARE and HOME CARE market segments. P113 line of products include mouthrinse solution, oral mouth spray, feminine cleansing wash, feminine soothing spray, antibacterial hand cream etc., and can be purchased at various local pharmacies in Taiwan and online at www.p113lab.com.
The Company is currently collaborating with GBC in developing P113 products specifically targeted at the relief of dry mouth symptoms, as well as expanding product distribution channels globally.