Positive Phase I/II Results For Proprietary Molecule CZEN-002 For The Treatment of Vaginal Yeast Infection
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Zengen Inc have been carrying out tests using a new proprietary molecule treatment CZEN-002 on vulvovaginal candidiasis (VVC) also known as vaginal yeast infection. They were looking at how safe the treatment was, as well as the pharmacokinetics and tolerability of CZEN-002 in yeast infection patients.
VVC is the most common genital health problem that women look for health advice and self treatment options over. Experts estimate that around three quarters of women will deal with at least one yeast infection in their lives, with nearly half of women going on to have more than one episode. 5% of women have chronic yeast infection, where they get a recurring infection four or more times a year.
CZEN-002 was developed after 25 years of research and is a non-azole, anti-fungal synthetic octapeptide. As well as anti-fungal it has also shown anti-inflammatory and anti-infective activities in vivo and vitro research. In studies CZEN-002 killed pathological fungi including the cause of yeast infections Candida Albicans.
In this study were 20 women with VVC, and 17 completed it. The study found that the treatment period for positive results with CZEN-002 was 5 days. There were no severe negative reactions to it. 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 says,
“This trial clearly established the efficacy of CZEN-002. The encouraging results provide hope that this compound may become a new treatment option for the millions of women diagnosed each year with VVC.”
CZEN-002 was administered vaginally in gel form and as well as looking at the tolerability and safety researchers were also looking at how well it was absorbed systemically. Overall CZEN-002 was well tolerated by the patients with some minor reactions reported that could equally have been the VVC itself. There was no sign that the drug accumulated or absorbed internally and tests done on urine, chemistry and hematology showed nothing unusual.
“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 .”
“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.”
http://www.medicalnewstoday.com/articles/8825.php
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