Clinical Data, Inc. and Dana-Farber Cancer Institute Form Research Collaboration to Study Role of FCGR3A Gene Variants for Predicting Clinical Outcomes in Breast Cancer Treatment

- Program to Validate Genetic Variants and Discover New Genetic Associations
Impacting Trastuzumab Response -
NEWTON, Mass.--(Business Wire)--
PGxHealth, a division of Clinical Data, Inc. (NASDAQ: CLDA), today announced
that it has established a research collaboration with the Dana-Farber Cancer
Institute (DCFI) to validate the use of geneticvariants in Fc gamma receptors
(FCGRs), including FCGR3A, in predicting response to trastuzumab (Herceptin)
therapy in patients with breast cancer. The research, directed by Karen S.
Anderson, M.D., Ph.D. at Dana-Farber, complements other studies underway to
further demonstrate the contribution of genetic variants in the FCGR family to
monoclonal antibody (mAb) response in cancer treatment. Importantly, the
collaboration includes a large-scale effort to discover new genetic variants
influencing response to Herceptin that may also predict response to other mAbs
of the IgG1 class. The collaboration expands PGxHealth`s FCGR program, which
includes its PGxPredict®:RITUXIMAB test for a gene variant used to determine
response to rituximab monotherapy in follicular non-Hodgkin`s lymphoma. Fc gamma
receptors are antibody receptors found on immune-regulatory white blood cells,
such as T-cells.

PGxHealth scientists will collaborate with Dr. Anderson and her colleagues to
analyze certain genetic variants in breast cancer patients enrolled in two
independent studies and receiving Herceptin along with other drugs in the
neoadjuvant setting (before primary treatment), or in the setting of metastatic
disease. Researchers will evaluate FCGR genotypes and their association with
pathological and clinical response to Herceptin therapy. Preliminary data from
the studies is anticipated by the end of 2009.

"We are very excited to be working with Dr. Anderson and the Dana-Farber Cancer
Institute, a premier institution known for its ground-breaking cancer research,
to expand the potential clinical utility of testing for Fc gamma receptor
variants in oncology," said Marcia Lewis, Vice President, Biomarker Development
at PGxHealth. "This collaboration will enable us to expand our knowledge of the
role of FCGR and other inherited genetic variants of immune response as they
impact the use of monoclonal antibody therapies in cancer. In the future, it may
be possible to combine testing for inherited genetic factors with tumor markers,
such as HER-2/neu, KRAS and others, to develop diagnostic tests that will be
highly predictive of individual response to cancer therapies."

The role of genetic variation in FCGR3A continues to gain attention among
researchers and clinicians. The impact of FCGR3A and other genes in the FCGR
gene family for optimizing treatment of lymphomas, breast, and colorectal
cancers with rituximab, trastuzumab, cetuximab and other recombinant mAbs was
the focus of the MAb IMPACT meeting of oncology experts, held in November 2008
in Tours, France.

FCGR3A, a gene that encodes an Fc gamma receptor, binds both natural and
therapeutic IgG1 antibodies. The FCGR3A receptor transmits signals from the
membrane into the cell via tyrosine kinase activity. This signaling pathway is
important in regulating antibody-dependent cellular cytotoxicity (ADCC), a
mechanism that is important to the efficacy of many mAb therapies. Recent
studies have suggested that genotyping FGCR3A and other Fc gamma receptors may
be important in predicting response to cetuximab in colorectal cancer and to
trastuzumab in breast cancer1,2.

Breast cancer is one of the most prevalent types of cancer in the U.S., with
over 180,000 new cases diagnosed annually3. Treatment recommendations for breast
cancer patients include various combinations of surgery, radiotherapy,
chemotherapy, hormonal therapy and biologic therapy with therapeutic monoclonal
antibodies. However, even with optimal therapy, a significant number of women
develop recurrent disease, highlighting the need for new and more effective
therapeutic approaches4.

About PGxPredict®:RITUXIMAB Test

PGxHealth`s PGxPredict:RITUXIMAB test detects a single nucleotide polymorphism
in FCGR3A that has been found to independently predict the response of patients
with follicular non-Hodgkin`s lymphoma to treatment with rituximab monotherapy.
For more information, please contact 877-2-PGxHealth (877-274-9432) or visit
www.pgxhealth.com.

About PGxHealth

PGxHealth, a division of Clinical Data, Inc., is utilizing its biomarker
expertise and intellectual property to develop and commercialize targeted
therapeutics as well as genetic and pharmacogenomic tests that detect serious
diseases and help to predict drug safety and efficacy. By using innovative
technologies and working with some of the world`s most prestigious genomics
thought leaders and institutions, PGxHealth is focused on improving clinical
outcomes and reducing treatment costs in disease states and therapeutic classes
with expensive, inefficient or suboptimal treatment options. Among its tests are
the FAMILION® and the PGxPredict® brands. Please visit the website at
www.pgxhealth.com.

About Clinical Data, Inc.

Clinical Data is a global biotechnology company unlocking the potential of
genomic discovery, From Targeted Science to Better Healthcare®. The Company is
utilizing its biomarker expertise and intellectual property to develop and
commercialize targeted therapeutics, as well as genetic and pharmacogenomic
tests to detect serious diseases and help predict drug safety, tolerability, and
efficacy, thereby improving health while reducing costs. Clinical Data is
leveraging advances in molecular discovery to provide tangible benefits for
patients, healthcare professionals and payors worldwide. To learn more, please
visit the Company's website at www.clda.com.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

This press release contains certain forward-looking information and statements
that are intended to be covered by the safe harbor for forward looking
statements provided by the Private Securities Litigation Reform Act of 1995.
Forward-looking statements are statements that are not historical facts. Words
such as "expect(s)", "feel(s)", "believe(s)", "will", "may", "anticipate(s)" and
similar expressions are intended to identify forward-looking statements. These
statements include, but are not limited to, statements about our ability to
successfully integrate the operations, business, technology and intellectual
property obtained in our acquisitions; our ability to obtain regulatory approval
for, and successfully introduce our new products; our ability to expand our
long-term business opportunities; financial projections and estimates and their
underlying assumptions; and statements regarding future performance. All of such
information and statements are subject to certain risks and uncertainties, the
effects of which are difficult to predict and generally beyond the control of
the Company, that could cause actual results to differ materially from those
expressed in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include, but are not limited to,
whether our PGxPredict® tests, including but not limited to FAMILION, will gain
wide acceptance in the market; the extent to which genetic markers are
predictive of clinical outcomes and drug efficacy and safety; the strength of
our intellectual property rights; competition from pharmaceutical, biotechnology
and diagnostics companies; the development of and our ability to take advantage
of the market for pharmacogenetic and biomarker products and services; whether
Clinical Data will be able to develop or acquire additional products and attract
new business and strategic partners; and those risks identified and discussed by
Clinical Data in its filings with the U.S. Securities and Exchange Commission.
Readers are cautioned not to place undue reliance on these forward looking
statements that speak only as of the date hereof. Clinical Data does not
undertake any obligation to republish revised forward-looking statements to
reflect events or circumstances after the date hereof or to reflect the
occurrence of unanticipated events. Readers are also urged to carefully review
and consider the various disclosures in Clinical Data's SEC periodic and interim
reports, including but not limited to its Annual Report on Form 10-K for the
fiscal year ended March 31, 2008, Quarterly Report on Form 10-Q for the fiscal
quarter ended December 31, 2008, and Current Reports on Form 8-K filed from time
to time by the Company.

1 Zhang W et al. Journal of Clinical Oncology. 2007 Aug 20;25(24):3712-8.

2 Musolino A et al. Journal of Clinical Oncology. 2008 Apr 10;26(11):1789-96.

3 National Cancer Institute: http://www.cancer.gov/cancertopics/types/breast

4 Dahabreh IJ et al. The Oncologist. (2008) 13:620-630.

Herceptin is a registered trademark of Genentech, Inc.

Clinical Data, Inc.
Theresa McNeely
Vice President
Corporate Communications
617-527-9933 x3373
or
General Business Inquiries
617-527-9933 x3388

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