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Zengen reports positive phase I/II trial results of its peptide molecule for vaginal yeast infection

(May 25, 2004) Zengen Inc. announced today positive phase I/II results for its proprietary molecule CZEN-002 for the treatment of vulvovaginal candidiasis (VVC), commonly known as vaginal yeast infection. The open label, non-randomized study was designed to evaluate the safety, tolerability and pharmacokinetics of CZEN-002 in patients with VVC.

The majority of subjects in the study reported evidence of efficacy as determined by potassium hydroxide (KOH) tests and mycological cultures - 88.2 percent and 87.5 percent, respectively. A total of 20 female patients with VVC were enrolled and treated in the trial, and 17 completed the study. KOH testing and mycological cultures indicated that CZEN-002 is active and that five days of treatment provided positive evidence of anti-infective efficacy. CZEN-002 appeared safe and well-tolerated with no severe adverse reactions. In 100 percent of the plasma samples evaluated, concentrations of CZEN 002 were either not detected or were below the limit of quantitation.

"This trial clearly established the efficacy of CZEN-002," said William Smith, M.D., F.A.C.C., lead study investigator and associate professor, clinical medicine, at Tulane University School of Medicine and Louisiana State University Medical Center. "The encouraging results provide hope that this compound may become a new treatment option for the millions of women diagnosed each year with VVC."

The primary objective of the study was to evaluate the safety and tolerability of vaginally administered CZEN-002. A secondary objective was to assess the systemic absorption of CZEN-002 as determined by the plasma concentrations of the molecule through 21 days following dosing. The CZEN 002 was delivered to the 20 patients in a vaginal gel specifically designed for the purpose of the study.

"This clinical trial marks a major milestone for Zengen," said James M. Lipton, Ph.D., chief scientific officer of Zengen. "Our peptide appears to
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Contact: Cattaliya Snider
sniderc@ruderfinn.com
310-479-9929
Zengen
25-May-2004


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