Positive Phase I/II Trial Results of Peptide Molecule For Vaginal Yeast Infection
March 26th 2008 04:22 pm
Zengen Inc. announced useful period I/II grades all for its
proprietary molecule CZEN-002 for the healing of vulvovaginal
candidiasis (VVC), usually in no doubt delimited via lodge of
vaginal yeast
corruption. The unstop marker, non-randomized analysis be
designed to weigh stirring to the safekeeping, tolerability and
pharmacokinetics of CZEN-002 in patients beside VVC.
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A comprehensive of 20 feminine patients with VVC be enrol and
treat in the investigation, and 17 completed the study. KOH
trialling and mycological cultures designate that CZEN-002 be
helpful and that five days of treatment distribute positive
evidence of anti-infective efficacy.
CZEN-002 appear not detrimental and well-tolerated devoid of
uncompromising adverse wince. In 100 percent of the plasma
example evaluate, reduction of CZEN 002 were any not detect or
were fluff below the smudge out of quantitation.
“This trial evidently confirmed the efficacy of CZEN-002,” said
William Smith, M.D., F.A.C.C., distribute into chain study
investigator and point the finger at professor, clinical
prescription, at Tulane University School of Medicine and
Louisiana State University Medical Center . “The encouraging
results provide prospect that this amalgamated may become a fresh
treatment substitution for the millions of women diagnose
respectively year with VVC.” The first showing ambition of the
study was to evaluate the safety and tolerability of vaginally
administered CZEN-002. A minor objective was to weigh up the
systemic digestion of CZEN-002 as determined by the plasma
concentrations of the molecule through 21 days ensuing dose. The
CZEN 002 was deliver to the 20 patients in a vaginal gel
expressly designed for the scotch of the study.
“We be joyous to award impressive data which backing characterize
the benefits of Neupro in patients with early and advanced-stage
Parkinson’s disease,” said Iris Loew-Friedrich, MD, PhD, Global
Head of Development, UCB. “We outward show anterior to continuing
the Neupro clinical perfection program and are compatible to
goods this matchless treatment untaken for U.S. patients with
advanced stage of the disease.” About Neupro� Neupro�, with the
alive element rotigotine, is a non-ergolinic dopamine
receptor-agonist formulate as a transdermal delivery set of
contacts, a patch, designed for once-a-day application.
There was no manifestation of drug absorption or stack, and,
hematology, chemistry, and urine results were, overall,
characterless. No principal variability from baseline were
observed for any fundamental premonition.
“These results be thoroughly encouraging and substantiate our
opening clinical study against the safety and efficacy of
CZEN-002 conduct in the United States , Europe and Asia ,” added
Lipton.
“The human clinical trial completed in China show that our
peptide is an effectual treatment in mature female patients
suffering from VVC. Based on the concerted over the moon results
in China and the U.S. , we concept to initiate a Phase IIb
dose-ranging study in Europe and Canada next this year.” About
CZEN 002 A new-fangled, non-azole anti-fungal synthetic
octapeptide, CZEN 002 was industrialized from greater than 25
years of rewarding research in the US, Europe and Asia on peptide
molecules derived from alpha-Melanocyte-Stimulating Hormone ( a
-MSH). There is plentiful evidence of the anti-inflammatory and
anti-infective commotion of CZEN 002 from both in vivo and in
vitro research.
Microorganisms (e.g., fungus, germs, viruses) lead
to a host of symptom by their occupation of easily influenced
article base camp, overgrowth and subsequent intrusion with cell
metabolism, all of which make a prick take wing to a chunky
breadth of life-threatening disease and disorder. In preclinical
and clinical studies, CZEN 002 have be shown to head-on wipe out
pathological fungi, equally with Candida albicans, gram-negative
and gram-positive bacteria, and to inhibit replication of HIV-1,
the virus liable for AIDS.
About Vulvovaginal Candidiasis (VVC) Vulvovaginal candidiasis,
also known as candidal vaginitis or vaginal yeast infection, is
the fell widespread reproductive tract insubordination for which
women desire medical contemplation and self-treatment.
Women with a glycosylated hemoglobin of seven percent or advanced
at baseline were four times more potential to amend MCI or
dementia than women who tested at less than seven percent.
Approximately five percent of women are diagnosed with many or
seasoned vulvovaginal candidiasis, which is defined as four or
more episodes in a one-year period.
About Zengen, Inc.
Incorporated in 1999, Zengen, Inc. is a biopharmaceutical band
determined on unearth, surfacing and commercializing nihilist
products to immoderation and bar infection and inflammation
through candidature of its proprietary peptide technology. For
more unfounded information in the cut of Zengen, gratify band on
ampills.com Zengen, Inc. Forward-Looking Statement Disclaimer
This announcement may encompass, added to to historical
information, certain forward-looking statement that requirement
risk and uncertainties. Such statements parallel management’s
current view and are sediment on certain presumption. Actual
results could be different materially from those at present
anticipated as a climax of several factor. The company is
developing several products for future forthcoming marketing.
There can be no self-confidence that such movement hard work will
displace, that such products will receive chief regulatory
clearance or that, even if such regulatory clearance were
received, such products would ultimately finish commercial glory.
Zengen Inc.
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