Genaissance Allowed Patent for Method of Testing Individuals for Genetic Predisposition to Reduced Metabolism of Drugs
2005年3月11日 - 9:30PM
PRニュース・ワイアー (英語)
Genaissance Allowed Patent for Method of Testing Individuals for
Genetic Predisposition to Reduced Metabolism of Drugs Ability to
Metabolize Certain Drugs Linked to Genetic Variant Present in over
10% of Americans NEW HAVEN, Conn., March 11 /PRNewswire-FirstCall/
-- Genaissance Pharmaceuticals, Inc. (NASDAQ:GNSC), a leading
developer and user of genetic information to help guide medical
therapy, has received a notice of allowance from the U.S. Patent
and Trademark Office. The allowed patent, which is co-owned with
Duke University, claims testing for a common genetic variant in the
CYP3A4 gene to predict poor metabolism of certain drugs. It is
estimated at least 50 percent of all drugs, including
chemotherapeutic agents and a wide variety of over-the-counter
medications, are metabolized by the CYP3A4 enzyme. Individuals with
a reduced ability to metabolize these drugs may be exposed to
higher levels of the drug, placing them at risk for adverse drug
reactions. The allowed patent, "Methods for Evaluating the Ability
to Metabolize Pharmaceuticals," describes the selection of
chemotherapeutic agents based on the presence or absence of this
variant, which is commonly called CYP3A4*1B. The patent also
describes how a mutation in the GSTM1 gene affects drug metabolism.
In addition to the pharmacogenetic uses described above, the
CYP3A4*1B variant may also be useful in identifying individuals at
risk for prostate and breast cancer. An earlier related patent
(U.S. 6,432,639: Isolated CYP3A4 Nucleic Acid Molecules and
Detection Methods, which is solely owned by Genaissance) describes
the discovery of the CYP3A4*1B variant and its detection. "This is
a significant addition to our intellectual property estate covering
key drug-response markers because such a large number of important
drugs are metabolized by CYP3A4," notes Kevin Rakin, President and
Chief Executive Officer of Genaissance. Mr. Rakin indicated the
company's CYP3A4*1B assay technology may ultimately be incorporated
in a simple DNA test that would provide potentially valuable
prescribing information to physicians. "The clinical utility would
be to appropriately dose medications that could cause harm if not
fully metabolized, especially in the elderly or in cases where
patients are receiving multiple drugs," he added. Along with a wide
variety of other clinical genetic assays for drug metabolism,
Genaissance offers a CYP3A4*1B genotyping service. This service is
used by major pharmaceutical companies in their drug development
programs. About Genaissance Genaissance Pharmaceuticals, Inc. is
developing innovative products based on its proprietary
pharmacogenomic technology and has a revenue-generating business in
DNA and pharmacogenomic products and services. Genaissance also
markets its proprietary FAMILION(TM) Test, designed to detect
mutations responsible for causing Familial Long QT and Brugada
Syndromes, two causes of sudden cardiac death. The Company's
product development strategy is focused on drug candidates with
promising clinical profiles and finding genetic markers to identify
a responsive patient population. This strategy enables Genaissance
to leverage existing clinical data and, thus, reduce the costs and
risks associated with traditional drug development and increase the
probability of clinical success and commercialization. The
Company's lead therapeutic product, vilazodone for depression, is
in Phase II of development. For more information on Genaissance,
visit our website at: http://www.genaissance.com/. This press
release contains forward-looking statements, including statements
about the expected issuance of the patent covering the DecoGen(R)
Informatics System, the expected growth and development of
Genaissance's business, such as Genaissance's efforts to build a
drug candidate pipeline, the timing and outcome of its genetic
testing programs, the ability of Genaissance to apply its
technologies to the development, marketing and prescribing of drugs
and Genaissance's ability to detect associations between clinical
outcomes and genetic variation. Such statements are subject to
certain factors, risks and uncertainties that may cause actual
results, events and performance to differ materially from those
referred to in such statements, including, but not limited to, the
extent to which genetic markers (haplotypes) are predictive of
clinical outcomes and drug efficacy and safety, the attraction of
new business and strategic partners, the adoption of our
technologies by the pharmaceutical industry, the acceptance of our
cardiac tests by health care providers, the timing and success of
clinical trials, competition from pharmaceutical, biotechnology and
diagnostics companies, the strength of our intellectual property
rights and those risks identified in our Quarterly Report on Form
10-Q for the quarter ended September 30, 2004, filed with the
Securities and Exchange Commission on November 15, 2004, and in
other filings we make with the Securities and Exchange Commission
from time to time. The forward-looking statements contained herein
represent the judgment of Genaissance as of the date of this
release. Genaissance disclaims any obligation to update any
forward-looking statement. DATASOURCE: Genaissance Pharmaceuticals,
Inc. CONTACT: Richard S. Judson, Ph.D., Chief Scientific Officer,
Senior Vice President, R&D of Genaissance Pharmaceuticals,
Inc., +1-203-726-3617, ; or Investors - Rhonda Chiger of Rx
Communications, +1-917-322-2569, ; Media - Tom Redington of
Redington, Inc., +1-203-222-7399, , both for Genaissance
Pharmaceuticals, Inc. Web site: http://www.genaissance.com/
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