Pacgen initiates Phase IIb clinical trial for treatment of oral candidiasis

This study will be a randomized, examiner-blinded, parallel design trial comparing three different doses of PAC-113 to Nystatin, a topical mouth rinse treatment for oral candidiasis.

The study is expected to be completed in the second quarter of 2008, and will enroll approximately 200 seropositive HIV patients with oral candidiasis in a number of US and South African centers.

Final results from the previous Phase I/II trial showed per protocol PAC-113 treated group had a complete clinical cure rate of 44%, comparable to the per protocol Nystatin treated group at 40%. Results confirm that PAC-113 was generally safe, well tolerated, and active in the treatment of oral candidiasis infection.

Pacgen believes the optimized formulation of PAC-113 will show superior clinical efficacy as compared both to the prior PAC-113 formulation and to Nystatin.

PAC-113 is a 12 amino-acid antimicrobial peptide derived from a naturally occurring histatin protein found in human saliva.