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Tuesday April 24, 5:00 pm Eastern Time
Press Release
SOURCE: Genaissance Pharmaceuticals, Inc.
Genaissance Pharmaceuticals Launches Largest Personalized Medicine
Clinical Study
Patient Enrollment Started In Study To Link Statin Drug Response to Genomic Markers
NEW HAVEN, Conn., April 24 /PRNewswire Interactive News Release/ -- Genaissance Pharmaceuticals, Inc. (Nasdaq:
GNSC - news), today announced that patient enrollment has started for the largest prospective clinical trial ever conducted to
discover how physicians can personalize prescriptions using information about human genomic variation. The STRENGTH
(Statin Response Examined by Genetic HAP(TM) Markers) Study is designed to provide the information necessary for
physicians to decide which cholesterol lowering drug is best for each patient based on their own genetic make up.
``This is an exciting time in medicine,'' said Dr. Antonio Gotto, Dean, Cornell Medical College and Chair of the STRENGTH
Study Steering Committee. ``The STRENGTH Study is the earliest application of pharmacogenomics to one of the most
prevalent public health problems -- high cholesterol.''
The STRENGTH Study will enroll approximately 600 patients at 60 medical centers in the United States with
approximately150 patients enrolled in each of the four treatment arms. The four drugs under study are: Lipitor®(1)
(atorvastatin), Zocor®(2) (simvastatin), Pravachol®(3)(pravastatin) and Baycol®(4) (cerivastatin). These drugs had sales of
nearly $13 billion in 2000 and were prescribed for approximately 10 million patients in the U.S. At the end of the study, which
will take approximately one year, Genaissance believes it will have the HAP(TM) Markers (akin to genomic bar codes) that
predict an individual's improvement in cholesterol, as well as potential side effects, in response to a particular statin.
``Today, physicians find that many of their patients don't respond optimally to their prescriptions and side effects can't be
predicted,'' said Dr. Kenneth Kashkin, EVP and Chief Medical Officer of Genaissance Pharmaceuticals. ``We believe that the
STRENGTH Study will lead the way in replacing trial and error medicine with genomically-guided treatment decisions so that
the right drug at the right dose reaches the patient.''
The STRENGTH Study is a prospective, randomized, open-label trial that will enroll male and female volunteers ranging from
18 to 75 years with a diagnosis of type IIa or IIb hypercholesterolemia. Investigators will be unaware, or blinded, to each
patient's genetic information. All genetic information will be kept confidential and will not be identified by patient name. Patient
volunteers will be treated for eight weeks at the recommended starting dose of each drug and then treated for another eight
weeks at the highest allowed dose as stated in the approved labeling for each medication.
``The initiation of the STRENGTH Study is another milestone event for Genaissance,'' said Dr. Gualberto Ruano, CEO of
Genaissance. ``Our application of discoveries from the human genome may have broad implications in terms of improving
public health and the ability of pharmaceutical companies to differentiate their products.''
The STRENGTH Study is the first from the Company's Mednostics(TM) Program. Genaissance plans to expand on this work
and initiate several studies over the next year with leading drugs in other major therapeutic categories, including asthma and
diabetes.
Genaissance Pharmaceuticals, Inc. is a leader in applying population genomics, informatics and clinical data to the development
of personalized medicines. The Company discovers genomic markers that are predictive of drug efficacy and safety and
markets its technology to the pharmaceutical industry as a complete solution for improving the development, marketing and
prescribing of drugs. Moving from discovery to commercial application, Genaissance has launched the largest prospective
clinical trial ever conducted with the goal of allowing physicians to personalize prescriptions based on the DNA of the patient.
Genaissance is located in Science Park in New Haven, Connecticut. Please visit genaissance.com for additional
information.
This press release contains forward-looking statements, including statements about the ability of Genaissance to apply its
technologies to the development, marketing and prescribing of drugs. 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 outcome of the STRENGTH Study and other clinical studies, the ability to convince the
pharmaceutical industry to adopt our technologies, competition from pharmaceutical, biotechnology and diagnostics companies,
the strength of our intellectual property rights and those risks identified in the Genaissance's Annual Report on Form 10-K filed
with the Securities and Exchange Commission on April 2, 2001. The forward-looking statements contained herein represent the
judgment of Genaissance as of the date of this release. Genaissance disclaims any intent or obligation to update any
forward-looking statement.
1 Registered trademark of Pfizer Inc.
2 Registered trademark of Merck & Company
3 Registered trademark of Bristol-Myers Squibb Company
4 Registered trademark of Bayer Corporation
SOURCE: Genaissance Pharmaceuticals, Inc. |
