PACGEN BIOPHARMACEUTICALS GETS APPROVAL FOR TRIAL OF PAC-113

Pacgen Biopharmaceuticals has received approval from the institutional review board (IRB) at the University of Southern California in Los Angeles to conduct a Phase I/II clinical study of PAC-113 mouthrinse for the treatment of oral candidiasis in HIV seropositive individuals.

The study is intended to assess the efficacy in eliminating clinical signs and symptoms of oral Candida infections and to evaluate the microbiological response of Candida to PAC-113, as well as evaluate the safety and tolerance of PAC-113 mouthrinse administered orally. It is a randomized, examiner-blinded, parallel design clinical trial with two treatment arms: PAC-113 mouthrinse and Nystatin oral suspension, a widely used treatment.