• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Clinical Data Launches Pharmacogenetic Test for Clozapine-Induced Agranulocytosis on Schedule

Posted on: Tuesday, 23 January 2007, 09:01 CST

Clinical Data, Inc. (NASDAQ: CLDA), announced today that its PGxHealth™ division, provider of Therapeutic Diagnostics™, has launched a new test, PGxPredict:CLOZAPINE™, a pharmacogenetic test designed to aid physicians prescribing or considering prescribing clozapine. This is the first of several tests that Clinical Data intends to release this year, again demonstrating its ability to develop, validate and commercialize proprietary, pharmacogenetic tests in the ever-evolving field of pharmacogenetics.

The PGxPredict:CLOZAPINE test will provide information on whether a patient is at Higher or Lower Risk of developing clozapine-induced agranulocytosis (CIA) compared to the untested population. The test is intended to be used as an adjunct to existing clinical information to aid in determining the risk of developing CIA and in determining the risk-benefit ratio of treatment with clozapine. As demonstrated in the CATIE (Clinical Antipsychotic Trials for Interventions Effectiveness) study, clozapine, a generic, relatively inexpensive atypical antipsychotic, is one of the most effective treatments for treatment-resistant schizophrenia.

"I am excited to have contributed to the development of this test," said Stanton Gerson, M.D., Shiverick Professor of Hematological Oncology and Director of the Ireland Cancer Center at University Hospitals Case Medical Center. "It can be used by psychiatrists and hematologists alike in both the ongoing management of patients already being treated with clozapine and in the assessment of patients being considered for clozapine treatment. I am looking forward to this test becoming available as well as to additional refinements through continued research by PGxHealth. It is my hope that this information may lead someday to reduced blood monitoring requirements and broader use of this very effective medication for treating schizophrenia."

PGxPredict:CLOZAPINE places patients into one of two categories: Higher Risk or Lower Risk, through the analysis of a simple blood sample and the genotyping of two single nucleotide polymorphisms in the gene HLADQB1. This gene has been shown by PGxHealth to be associated with CIA in 2 independent case-control cohorts. Based on these studies, Higher Risk patients have a 2.5 relative risk of developing CIA in comparison to general clozapine-treated patients, while Lower Risk patients have a 0.5 relative risk.

"Today we prescribe to an individual based on what is expected from studies of large heterogenous populations and watch to see how the patient responds," said Carol Reed, Chief Medical Officer of Clinical Data. "With PGxPredict tests, doctors can make more informed treatment decisions specific to each patient. Based on the results of this test, physicians will be able to prescribe clozapine with more confidence and patients will have greater comfort that they can take this efficacious drug safely."

For more information on the PGxPredict:CLOZAPINE test, call 1-877-2-CIA-TEST (877-224-2837) or email ciatestinfo@pgxhealth.com.

PGxHealth provides the following genetic tests to practitioners: FAMILION®, a genetic test designed to identify mutations in people with inherited cardiac channelopathies such as Long QT Syndrome (LQTS) and Brugada Syndrome; PGxPredict: WARFARIN, a pharmacogenetic test that measures variation in 2 genes related to response to warfarin; and a pharmacogenetic assay that tests for mutations in the thiopurine S-methyl transferase (TPMT) gene, exclusively licensed from St. Jude Children's Research Hospital and offered through Prometheus Laboratories Inc. and Specialty Laboratories (a wholly owned subsidiary of Ameripath, Inc.), that provides an assessment of a patient's ability to metabolize the thiopurine class of drugs, prescribed in a wide range of therapeutic areas including oncology, rheumatology, organ transplantation and vasculitis.

About Clozapine

Phase II of the CATIE study confirmed that clozapine was more effective than other atypical antipsychotics for patients who had previously discontinued from a different atypical antipsychotic treatment.

However, clozapine is a third-line treatment option for schizophrenia. In part, this is because of the risk of CIA which occurs in an estimated 1.3% of patients based on pre-market data with no prospective blood monitoring. The requirement for blood monitoring, as described on the clozapine package insert, has reduced the incidence of CIA to 0.3-0.4%. The use of PgxPredict:CLOZAPINE does not eliminate the need for monitoring of white blood cell counts and absolute neutrophil counts as recommended in clozapine prescribing information.

About PGxHealth

PGxHealth™ has extensive experience and capabilities in the development, clinical validation and delivery of genomic-based tests, in particular of efficacy and safety biomarkers for appropriate drug utilization. Through its own know-how and resources, work conducted with some of the world's most prestigious genomics thought leaders and institutions, and use of innovative technologies, PGxHealth is focused on reducing treatment costs and improving clinical outcomes in those disease states and therapeutic classes beset with expensive, inefficient or suboptimal treatment options. It has branded its genetic tests based on these proprietary genetic markers Therapeutic Diagnostics™.

About Clinical Data, Inc.

Clinical Data, Inc. is a global biotechnology company unlocking the potential of molecular discovery, from targeted science to better healthcare. Its PGxHealth division focuses on genetic test and biomarker development to help predict drug safety and efficacy, thereby reducing health care costs and improving clinical outcomes. Its Cogenics division provides molecular and pharmacogenomics services to both research and regulated environments. Its Vital Diagnostics division offers in vitro diagnostics solutions for the clinical laboratory. Through these divisions, Clinical Data is leveraging advances in molecular discovery to provide tangible benefits for patients, doctors, scientists and health plans worldwide.

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

This press release contains certain forward-looking information about Clinical Data that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. 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 regarding: 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; our ability to maintain normal terms with our customers and partners; financial projections and estimates and their underlying assumptions; and statements regarding future performance. All of such statements are subject to certain risks and uncertainties, many 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 will gain wide acceptance in the market; the extent to which genetic markers (haplotypes) are predictive of clinical outcomes and drug efficacy and safety; our ability to achieve the expected synergies and operating efficiencies from all of our acquisitions; 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; general economic downturns; and other risks contained in our various SEC reports and filings, including but not limited to our Quarterly Report on Form 10-Q for the quarter ended September 30, 2006, and our subsequent Current Reports on Form 8-K filed with the 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, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

Internet Website: www.clda.com

Source: Business Wire

More News in this Category