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Clinical Data Achieves Validation of Genetic Biomarker for Determining Risk of Clozapine Induced Agranulocytosis.


NEWTON, Mass. -- Clinical Data, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:CLDA CLDA California Lyme Disease Association ):

--Clinically Validated Gene in HLA Complex HLA complex
n.
See major histocompatibility complex.
 Basis for First Genetic Risk Assessment Tool for Clozapine-Induced Agranulocytosis agranulocytosis (əgrăn'yəlōsītō`sis), disease in which the production of granulated white blood cells by the bone marrow is impaired.  (CIA CIA: see Central Intelligence Agency.


(1) (Confidentiality Integrity Authentication) The three important concerns with regards to information security. Encryption is used to provide confidentiality (privacy, secrecy).
), a Serious Adverse Drug Reaction adverse drug reaction,
n a detrimental outcome from a drug. Two types of ADRs exist: Type 1 results from dosage mismatch and Type 2 from rare conditions often as a consequence of a small dose. See also risk or sensitive type.
 

--Novel Finding is Basis for Forthcoming Test in 2006 for CIA Risk and Ongoing Work with Respect to Other Drug-Induced Agranulocytoses

--Clozapine Recognized for Therapeutic Efficacy in Treatment Refractory Schizophrenia but Relegated to Third Line Treatment

Clinical Data, Inc. (NASDAQ:CLDA), a worldwide leader in providing comprehensive molecular and pharmacogenomics services as well as clinical diagnostics to improve patient care, announced today that its PGxHealth division has completed the validation of a genetic marker genetic marker
n.
A gene phenotypically associated with a particular, easily identified trait and used to identify an individual or cell carrying that gene.
 that will help identify patients at risk for Clozapine-Induced Agranulocytosis (CIA), a potentially deadly blood disorder. This gene is located in the HLA complex, an area that, as has been previously reported, is associated with CIA.

The Company also announced that it is developing a commercial genetic test, an example of PGxHealth's branded Therapeutic Diagnostics(TM), for CIA risk using this newly validated research. PGxHealth expects to launch this new genetic test in 2006. In addition, Clinical Data notes that its research team continues to work on identifying other biomarkers related to CIA to further improve the predictive power of this and next generation tests. The Company further noted that other drugs also induce agranulocytosis as well as neutropenia Neutropenia Definition

Neutropenia is an abnormally low level of neutrophils in the blood. Neutrophils are white blood cells (WBCs) produced in the bone marrow that ingest bacteria.
 (a somewhat less acute blood disorder which is often the precursor to agranulocytosis), and PGxHealth is actively investigating these findings with respect to other drugs.

PGxHealth's new test will provide physicians, patients and their families with new, quantifiable information about a patient's risk for CIA and should lead to better informed treatment decisions concerning initiating or continuing treatment of schizophrenia The concept of a cure as such in the treatment of schizophrenia remains controversial, as there is no consensus on the definition of "treatment" in the case of schizophrenia, although some criteria for the remission of symptoms have recently been suggested.  with clozapine clozapine /clo·za·pine/ (klo´zah-pen) a sedative and antipsychotic agent; used in the treatment of schizophrenia.

clo·za·pine
n.
. Such a test also has the potential to expand the use of this highly efficacious drug, clozapine, and improve its safety profile. After the test's performance is substantiated in clinical use, the Company believes it may lead to a reduction in the frequency of blood monitoring in a subset of patients.

Dr. Stanton Gerson, Shiverick Professor of Hematological hematological, hematologic

pertaining to or emanating from blood cells.


hematological tests
total and differential white cell counts, hematocrit estimation, erythrocyte count.
 Oncology and Director of the Ireland Cancer Center at University Hospitals of Cleveland University Hospitals is a major not-for-profit medical center in Cleveland, Ohio, United States. With 150 locations throughout northeast Ohio, it encompasses a network of hospitals, outpatient centers and primary care physicians.  and Case Western Reserve University, commented, "I am excited to be contributing to the development of this test that can be used by psychiatrists and hematologists in the management of clozapine treatment or for the assessment of patients being considered for clozapine treatment. These results may also prove to be applicable to agranulocytosis or neutropenia induced by other drugs. I am looking forward to this diagnostic becoming available as well as to additional refinements through continued research by PGxHealth."

Clozapine, a generic drug generic drug, a drug sold or prescribed under the nonproprietary name of its active ingredients or under a generally descriptive name rather than under a brand or trade name.  with a lower cost than most drugs in its class, is the only drug used for treatment refractory schizophrenia proven to have superior efficacy to conventional neuroleptics Neuroleptics
Any of a class of drugs used to treat psychotic conditions.

Mentioned in: Stuttering, Tardive Dyskinesia
 and demonstrating a reduced risk of suicide in patients with schizophrenia. It is acknowledged as the "gold standard" for schizophrenia treatment. However, concerns regarding the side effects Side effects

Effects of a proposed project on other parts of the firm.
 of clozapine have negatively impacted its use. In a new study of schizophrenia drugs funded by the National Institute of Mental Health The National Institute of Mental Health (NIMH) is part of the federal government of the United States and the largest research organization in the world specializing in mental illness. , as reported in the April issue of the American Journal of Psychiatry The American Journal of Psychiatry (AJP) is the most widely read psychiatric journal in the world. It covers topics on biological psychiatry, treatment innovations, forensic, ethical, economic, and social issues. , clozapine emerged as the most effective second-line treatment - more effective than Risperdal, Seroquel, and Zyprexa according to lead author Dr. Joseph McEvoy of the Duke University Medical Center.

"The results from the NIMH sponsored study have provided more evidence that clozapine is one of the most effective medications for treating schizophrenia, although its use is limited due to the risk of inducing agranulocytosis," said John M. Kane, M.D., Chairman, Department of Psychiatry at The Zucker Hillside Hospital and Professor of Psychiatry, Neurology and Neuroscience at The Albert Einstein College of Medicine
For the engineering company, see AECOM


The Albert Einstein College of Medicine (AECOM) is a graduate school of Yeshiva University. It is a private medical school located in the Jack and Pearl Resnick Campus of Yeshiva University in the Morris Park
. "This validation of a genetic marker that helps assess risk of developing clozapine induced agranulocytosis brings us one step closer to someday alleviating the need for continuous blood monitoring for the majority of clozapine treated patients."

Carol Reed, M.D., Senior Vice President and Chief Medical Officer, said, "This validated clinical finding demonstrates PGxHealth's strength in developing medically and commercially viable pharmacogenetic tests. We will continue to refine the clinical utility of this test for both CIA and for other drug-induced blood and bone marrow abnormalities. The forthcoming genetic test for CIA risk is truly in the 'sweet spot' of PGxHealth's ongoing commercial focus -- the use of genetic biomarkers to guide drug therapy. Marker discovery and genetic test development and commercialization require highly specialized expertise, an area where PGxHealth excels and fills unmet medical and market needs."

Schizophrenia, a chronic disorder that begins in early adulthood, is a devastating dev·as·tate  
tr.v. dev·as·tat·ed, dev·as·tat·ing, dev·as·tates
1. To lay waste; destroy.

2. To overwhelm; confound; stun: was devastated by the rude remark.
 disease afflicting af·flict  
tr.v. af·flict·ed, af·flict·ing, af·flicts
To inflict grievous physical or mental suffering on.



[Middle English afflighten, from afflight,
 1% of the population across varied geographical regions and is characterized by delusional beliefs, auditory hallucinations, disorganized dis·or·gan·ize  
tr.v. dis·or·gan·ized, dis·or·gan·iz·ing, dis·or·gan·iz·es
To destroy the organization, systematic arrangement, or unity of.
 thought patterns and apathy. The social and financial implications of schizophrenia are high: patients withdraw socially, have difficulty sustaining relationships and are often unable to work. The cost of this loss of productivity combined with the burden of medical care is estimated to be some $32.5 billion per year in the U.S. alone.

About Clinical Data, Inc.

Clinical Data, Inc. is a worldwide leader in providing comprehensive molecular and pharmacogenomics services as well as clinical diagnostics to improve patient care. Clinical Data's Therapeutic Diagnostics(TM) division, PGxHealth, builds upon existing assets acquired from Genaissance Pharmaceuticals in the areas of genomics-based, clinical diagnostics, therapeutic efficacy and safety biomarker development for drug utilization. PGxHealth plans to develop and introduce novel Therapeutic Diagnostics in combination with new and existing therapeutics. Clinical Data's Pharmacogenomics and Molecular Services(TM) division, Cogenics, consolidates the operations of Genaissance Pharmaceuticals, Inc., Lark Technologies, Inc. and Icoria, Inc., each acquired during 2005, and Genome Express SA, acquired in 2006. Cogenics provides a comprehensive range of molecular and pharmacogenomics services to pharmaceutical, biotech, academia, agricultural, and government clients. These services are offered in both research and regulated environments and have applications across the lifecycle of pharmaceutical product development including pharmacovigilance requirements post-launch. Clinical Data's Vital Diagnostics division consolidates the operations of Clinical Data Sales & Service, Inc., Vital Scientific NV, Vital Diagnostics Pty. Ltd., and Electa Lab s.r.l. This division serves the clinical laboratory in the traditional in-vitro diagnostics market worldwide with a focus on the physician's office, hospital and small-to-medium sized laboratory segments. With customers in approximately 100 countries, Vital Diagnostics has achieved a leading market share for instruments and reagents sold into moderately complex physicians' office laboratories within the United States.

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 STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 recent acquisitions; our ability to obtain regulatory approval for, and successfully introduce our new products; our ability to expand our long-term business opportunities; our ability to maintain normal terms with our customers and partners; financial projections and estimates and their underlying assumptions; and statements regarding future performance. Such 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 Clinical Data will be able to develop or acquire additional products and attract new business and strategic partners; competition from pharmaceutical, biotechnology and diagnostics companies; the strength of our intellectual property rights; the effect on the Company's operations and results of significant acquisitions or divestitures made by major competitors; the Company's ability to achieve expected synergies and operating efficiencies in all of its acquisitions, and to successfully integrate its operations; and those risks discussed and identified by Clinical Data in its public 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 reports, including but not limited to its Annual Report on Form 10-KSB for the fiscal year ended March 31, 2005, and fiscal 2005 and 2006 quarterly reports on Forms 10-QSB and 10-Q.
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Publication:Business Wire
Geographic Code:1USA
Date:Apr 19, 2006
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