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Pacgen Announces Positive Results from Phase I/II Trial of Novel,Antifungal Drug

TSX-V: PGA

VANCOUVER, May 07, 2007 /PRNewswire-FirstCall/ - Pacgen Biopharmaceuticals Corporation ("Pacgen") is pleased to report that topline results from its Phase I/II study of PAC-113, a novel antifungal, show it is generally safe, well-tolerated, and active in the treatment of oral Candida infection with clinical cure rates comparable to the current standard of care. Based on these results the Company plans to initiate a Phase IIb study to optimize PAC-113 dose and formulation.

"For many immunocompromised patients oral candidiasis can be severe, impacting their ability to get appropriate nutrition. We are very encouraged by the PAC-113 results and its potential to help patients with oral candidiasis, particularly when available treatments have a number of limitations and drawbacks," said Dr. Neil Reiner, Professor and Head of Division of Infectious Diseases, UBC Department of Medicine and Vancouver General Hospital, and a member of Pacgen's Clinical Advisory Board

PAC-113 is a peptide based anti-fungal drug candidate targeting oral Candida infections in immunocompromised patients and patients with salivary dysfunction. The Phase I/II clinical trial of PAC-113 was conducted at sites in the United States and South Africa and recruited over 100 HIV seropositive patients with oral candidiasis.

The objective of this study was to provide safety data for PAC-113, as well as to establish first proof of efficacy for PAC-113 in eliminating clinical signs and symptoms of oral candidiasis. This Phase I/II study was a comparison between PAC-113 mouthrinse and Nystatin oral suspension. The study was a randomized, examiner-blinded, parallel design clinical trial that included a 14-day treatment phase, and a 14-day follow-up period, with a day 28 follow-up visit. Analyses were conducted on patients who were at least 80% compliant in the treatment phase.

Topline results show that 37% of PAC-113
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