Undertakes
Novel Genomic “Pre-profiling” Feasibility Study to Examine the Promise
of Precision Medicine in Metastatic Colorectal Cancer Patients
ME Newswire / Business Wire
RESEARCH TRIANGLE PARK, N.C. - Wednesday, September 25th 2013
Quintiles
today announced plans to improve the development of biomarker-targeted
therapies through a novel approach that promotes the genomic
“pre-profiling” of cancer patients. As a first step, Quintiles is
undertaking a study with the participation of US Oncology Research,
supported by McKesson Specialty Health and The US Oncology Network, to
explore the operational feasibility and clinical benefits of an upfront
approach to the genomic profiling of tumors from metastatic colorectal
cancer (mCRC) patients. The study will investigate how pre-profiling and
genomic sequencing data may support physician treatment decisions,
including the identification of appropriate clinical trials for
patients.
“Today, the industry’s approach to stratifying patients
through genomic screening is sequential – testing for oncology
biomarkers one at a time, and often only as part of screening for
participation in a single clinical trial,” explained Jeffrey Spaeder,
M.D., chief medical and scientific officer for Quintiles. “Early
indications from this study suggest that we can provide physicians and
patients with early visibility on potentially clinically actionable
biomarkers within a rapid two-week timeframe. This level and speed of
analysis has promise to save valuable time in administering potentially
life-saving therapies to patients, and reduce the development times of
precision medicines.”
As cancer research and care enter the era
of precision medicine, Quintiles is actively transforming the model for
testing new therapies. Pre-profiling may accelerate early testing of new
biomarker-targeted therapies by enabling biopharmaceutical companies to
focus on molecules with high potential for safety and effectiveness.
For cancer patients and physicians, pre-profiling enables the efficient
matching of the right patients to the right clinical studies, and
increases patient access to innovative therapies.
“Our work is
taking a critical step toward making precision medicine a reality,”
continued Spaeder. “Quintiles’ end-to-end design and delivery model for
connecting genomic testing with clinical trials supports the needs of
patients, physicians and drug developers. Our goal is to provide
oncology investigators and their patients with access to effective,
cutting-edge therapies through a model built upon experience and
high-quality cancer care.”
About the “Pre-profiling” Feasibility Study
The
primary objective of the study, titled “Feasibility study of Biomarker
Analysis for Patients with Metastatic Colorectal Cancer,” is to
determine the number of genetic changes that occur within mCRC patients
that are targeted by U.S. Food and Drug Administration approved
therapies, as well as those targeted by therapies in development. The
study will perform a broad-based biomarker analysis on mCRC patients,
and the results will be reported to the treating physicians in a
clinically meaningful format to help identify higher-risk patients and
aid in selecting better treatment options.
About Quintiles
Quintiles
(NYSE: Q) is the world’s largest provider of biopharmaceutical
development and commercial outsourcing services with a network of more
than 27,000 employees conducting business in approximately 100
countries. We have helped develop or commercialize all of the top-50
best-selling drugs on the market. Quintiles applies the breadth and
depth of our service offerings along with extensive therapeutic,
scientific and analytics expertise to help our customers navigate an
increasingly complex healthcare environment as they seek to improve
efficiency and effectiveness in the delivery of better healthcare
outcomes. To learn more about Quintiles, please visit www.quintiles.com.
Forward-Looking Statements
This
press release may contain forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Such forward-looking statements
reflect, among other things, Quintiles’ current expectations and
anticipated results of operations, all of which are subject to known and
unknown risks, uncertainties and other factors that may cause
Quintiles’ actual results, performance or achievements, market trends,
or industry results to differ materially from those expressed or implied
by such forward-looking statements. Therefore, any statements contained
herein that are not statements of historical fact may be
forward-looking statements and should be evaluated as such. Without
limiting the foregoing, the words “anticipates,” “believes,”
“estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “should,”
“targets,” “will” and the negative thereof and similar words and
expressions are intended to identify forward-looking statements. These
statements are subject to risks, uncertainties and assumptions described
under the section entitled "Risk Factors" in Quintiles’ prospectus
dated May 8, 2013, filed with the Securities and Exchange Commission
(“SEC”) on May 9, 2013, as such factors may be updated from time to time
in Quintiles’ periodic filings with the SEC, which are accessible on
the SEC's website at www.sec.gov. These factors should not be construed
as exhaustive and should be read in conjunction with the other
cautionary statements that are included in this release and in
Quintiles’ filings with the SEC. Unless legally required, Quintiles
assumes no obligation to update any such forward-looking information to
reflect actual results or changes in the factors affecting such
forward-looking information.
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Contacts
Quintiles
Mari Mansfield, + 1-919-998-2639
Media Relations
mari.mansfield@quintiles.com
Mobile: +1-919-259-3298
Karl Deonanan, +1-919-998-2789
Investor Relations
InvestorRelations@quintiles.com
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