all cylinders........
Tuesday November 27, 7:30 am Eastern Time
Press Release
SOURCE: Neurocrine Biosciences, Inc.
Neurocrine Biosciences Announces Initiation of Phase
I Clinical Trial With Orally Active GnRH Antagonist
for Women's Health Disorders and Prostate Cancer
SAN DIEGO, Nov. 27 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX -
news) announced today the completion of dosing of the first cohort of seven subjects in the
Phase I clinical trial with the company's proprietary, orally active, gonadotropin-releasing
hormone (GnRH) antagonist. GnRH is a hormone that regulates male and female reproductive
hormones. Injectable peptide drugs that block the action of GnRH have found broad clinical
utility in women's health disorders and prostate cancer in males. This trial is an oral single
dose, double-blind, placebo controlled, dose escalating Phase I study being conducted in up
to 56 normal, healthy volunteers and is designed to study the safety, pharmacokinetics and
pharmacodynamics of a number of doses of this compound. In addition, secondary endpoints
in the study will assess suppression of pituitary gonadotropins; an important surrogate
measurement of efficacy.
``This is an important milestone towards developing a potential new class of drugs to compete
in a $2.5 billion market in women's health and prostate cancer,'' said Dr. Henry Pan,
Executive Vice President of Clinical Development of Neurocrine.
Currently available GnRH agonists and antagonists are peptides, which generally are given as
injectable depots. We believe orally active, non-peptide GnRH antagonists should provide
increased dosing flexibility, convenience and greater patient acceptability over these current
treatments. Using high throughput parallel chemical synthesis of designed libraries, combined
with preclinical safety, pharmacokinetic (PK) and metabolic properties, Neurocrine's
approach has rapidly produced several series of proprietary highly potent, non-peptide
compounds.
``This program has moved very rapidly from basic research through preclinical studies to
Phase I clinical studies and continues to demonstrate the strength of Neurocrine's integrated
drug discovery and development capabilities,'' said Paul Conlon, Vice-President of Biology.
Neurocrine recently announced the award of a peer-reviewed Phase II SBIR grant from the
National Institutes of Health (NIH) to fund the development of orally active GnRH
antagonists. This grant will total approximately $1 million over a two-year period and will support research to discover and
evaluate current and next generation small molecule GnRH receptor antagonists for the treatment of uterine fibroids,
endometriosis, breast cancer, prostate cancer, infertility and other disorders linked to the endocrine system.
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases
and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia,
anxiety, depression, malignant brain tumors and peripheral cancers, diabetes, multiple sclerosis, irritable bowel syndrome,
eating disorders, pain, stroke, and certain female health disorders. Neurocrine Biosciences, Inc. news releases are available
through the Company's website via the Internet at neurocrine.com.
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and
uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward looking
statements are risks and uncertainties associated with Neurocrine's GnRH development program and Neurocrine's business
and finances including, but not limited to, risk that Neurocrine's GnRH antagonist compounds will not successfully proceed
through clinical trials or that later stage clinical trials will not show that they are effective in treating humans; determinations by
regulatory and governmental authorities; dependence on corporate collaborators who could terminate their relationships with
the Company at any time; uncertainties relating to patent protection and intellectual property rights of third parties; impact of
competitive products and technological changes; availability of capital and cost of capital; and other material risks. A more
complete description of these risks can be found in the Company's annual report on Form 10K for the year ended December
31, 2000 and the Company's quarterly report on Form 10Q each of which should be read before making any investment in
Neurocrine common stock. Neurocrine undertakes no obligation to update the statements contained in this press release after
the date hereof.
For further information, please contact Claudia Jones or Paul Hawran, of Neurocrine Biosciences, Inc., +1-858-658-7600.
SOURCE: Neurocrine Biosciences, Inc. |
