May 25 2004
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 represent a new class of non-azole, anti-fungal drug. This potentially makes our peptide technology a better therapeutic option than current prescription and OTC treatment regimens for VVC .”
Overall, safety results indicated that CZEN-002 was well-tolerated by the patients in the trial. The minor events reported during this trial were, generally, typical of patients suffering VVC. There was no indication of drug absorption or accumulation, and, hematology, chemistry, and urine results were, overall, unremarkable. No significant changes from baseline were observed for any vital sign.
“These results are very encouraging and confirm our preliminary clinical studies on the safety and efficacy of CZEN-002 conducted in the United States , Europe and Asia ,” added Lipton. "The human clinical trials completed in China showed that our peptide is an effective treatment in adult female patients suffering from VVC. Based on the combined successful results in China and the U.S. , we plan to initiate a Phase IIb dose-ranging study in Europe and Canada later this year.”
A novel, non-azole anti-fungal synthetic octapeptide, CZEN 002 was developed from more than 25 years of original research in the US, Europe and Asia on peptide molecules derived from alpha-Melanocyte-Stimulating Hormone ( a -MSH). There is abundant evidence of the anti-inflammatory and anti-infective activity of CZEN 002 from both in vivo and in vitro research.
Microorganisms (e.g., fungi, bacteria, viruses) cause a host of symptoms by their occupation of vulnerable body sites, overgrowth and subsequent interference with cell metabolism, all of which give rise to a broad range of life-threatening diseases and disorders. In preclinical and clinical studies, CZEN 002 has been shown to directly kill pathological fungi, including Candida albicans, gram-negative and gram-positive bacteria, and to inhibit replication of HIV-1, the virus responsible for AIDS.
Vulvovaginal candidiasis, also known as candidal vaginitis or vaginal yeast infection, is the most common reproductive tract disorder for which women seek medical care and self-treatment. It is estimated that 75 percent of all women will experience at least one episode of vulvovaginal candidiasis in their lifetime, with 40 to 50 percent experiencing two or more episodes. Approximately five percent of women are diagnosed with recurrent or chronic vulvovaginal candidiasis, which is defined as four or more episodes in a one-year period. http://www.zengen.com