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ZENGEN FILES IND NEW FOR VAGINAL YEAST INFECTION TREATMENT.


Zengen, Inc., Woodland Hills, Calif., has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for CZEN CZEN Critical Zone Exploration Network  002, one of the company's proprietary peptide molecules, for the treatment of vulvovaginal vulvovaginal /vul·vo·vag·i·nal/ (-vaj´i-n'l) pertaining to the vulva and vagina.

vul·vo·vag·i·nal
adj.
Of or relating to the vulva and the vagina.
 candidiasis candidiasis (kăn'dĭdī`əsĭs), infection of the mucous membranes caused by the fungus Candida albicans. Other terms for candidiasis are yeast infection, moniliasis (after a former name of the fungal genus), and thrush, the , commonly known as vaginal yeast infection Vaginal yeast infection
An overgrowth of fungus in the vaginal area.

Mentioned in: Jock Itch
. Zengen's peptides have broad applications as anti- inflammatory and anti-infective prescription pharmaceuticals and are based on the larger melanocortin peptide, alpha- Melanocyte-Stimulating Hormone melanocyte-stimulating hormone
n.
Abbr. MSH A hormone secreted by the pituitary gland that regulates skin color in humans and other vertebrates by stimulating melanin synthesis in melanocytes and melanin granule dispersal in melanophores.
 (a-MSH).

"This marks an important milestone for Zengen and our proprietary peptide technology," said R. Steven Davidson, Ph.D., president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Zengen. "Preclinical and clinical research has shown that our peptides inhibit inflammation and modulate immune responses, while at the same time have demonstrated efficacy in fighting infection. The combination of both anti-infective and anti-inflammatory properties in Zengen's peptide molecules suggests that they may be a more complete therapeutic option than steroids, which reduce inflammation but increase the risk of infection, or antibiotics, which are not effective in inhibiting inflammation."

Preclinical research conducted in the United States, Europe and Asia has proven the efficacy of CZEN 002. In addition, human clinical trials recently completed in China show that CZEN 002 is an effective treatment in adult female patients suffering from vulvovaginal candidiasis. The IND submission precedes the initiation of Phase I/II clinical trials in the US for patients suffering from vulvovaginal candidiasis.

"Preclinical and clinical studies completed in Italy and China show that CZEN 002 directly inhibits or kills Candida albicans, the major cause of all vaginal yeast infections," said James Lipton, Ph.D., chief scientific officer and director of Zengen. "Further, CZEN 002 relieved the clinical symptoms of vulvovaginal candidiasis without any noticeable side effects. Based on these encouraging findings, we are eager to pursue expanded clinical trials."

About CZEN 002

A synthetic octapeptide oc·ta·pep·tide  
n.
A polypeptide, such as angiotensin, that is composed of eight amino acids.
, 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 overgrowth

Rapid growth in the sales of a mutual fund's shares to the extent that the fund has difficulty finding promising new investments or it must take such large positions in individual investments that its trading flexibility is reduced.
 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.

About Vulvovaginal Candidiasis (VVC VVC Virtual Value Chain
VVC Voltage-Var Control
VVC Verification, Validation and Certification
VVC Victims of Violent Crime
VVC Variable Valve Control
) Vulvovaginal candidiasis, also known as candidal vaginitis vaginitis

Inflammation of the vagina. The chief symptom is a whitish or yellowish vaginal discharge. Treatment depends on the cause: appropriate drugs for sexually transmitted diseases (often from Gardnerella bacteria or trichomonads) or yeast infections; estrogen cream for
 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.

About Zengen, Inc.

Incorporated in 1999, Zengen, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative products to treat and prevent infection and inflammation through application of its proprietary peptide technologies.

For more information, visit http://www.zengen.com.
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Publication:Biotech Business
Date:Dec 1, 2002
Words:542
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