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news.Pacgen Biopharmaceuticals has completed the recruitment of patients in its Phase IIb dose-ranging clinical trial for PAC-113, a novel treatment for oral candidiasis infection. The company is on track to report final results from this study in June 2008.
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The Phase IIb dose-ranging clinical trial is a randomized, examiner-blinded, parallel design trial comparing three different doses of PAC-113 to Nystatin, consisting of two week treatment phase and two week post-treatment or follow up phase. Nystatin is a widely used, topical mouth rinse treatment for oral Candidiasis.
PAC-113 is a peptide-based anti-fungal targeting oral candida infections in immunocompromised patients. The Phase IIb dose-ranging clinical trial of PAC-113 is being conducted at sites in the US and South Africa and has now successfully recruited over 200 seropositive HIV patients with oral candidiasis.
The trial will establish the efficacy for PAC-113 in eliminating clinical signs and symptoms of oral candidiasis, as well as provide an optimal dosing level for Phase III pivotal trials. Further safety and tolerance of PAC-113 administered orally and microbiological response of Candida albicans to PAC-113 will also be evaluated.