May 20, 2006

Validation of Genetic Biomarker for Determining Risk of Clozapine Induced Agranulocytosis

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

Clinical Data, Inc. announced today that its PGxHealth division has completed the validation of a genetic marker that will help identify patients at risk for Clozapine-Induced Agranulocytosis (CIA), a potentially deadly blood disorder.

The Company also announced that it is developing a commercial genetic test, an example of PGxHealth's branded Therapeutic Diagnostics, 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.

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 with clozapine. 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 Oncology and Director of the Ireland Cancer Center at University Hospitals of Cleveland 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 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 and demonstrating a reduced risk of suicide in patients with chizophrenia. It is acknowledged as the "gold standard" for schizophrenia treatment.

However, concerns regarding the side effects of clozapine have Mental Health, as reported in the April issue of the American Journal of Psychiatry, 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.

"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,

Source: Press/Marketing Release from Clinical Data, Inc.



Sir, Not a single case of agranulocytosis is found among CLOZAPINE USERS in India. this bogey about this sideffect is created may be to sell other drugs like respirodone,olanzapine,quetepine etc.Drop in whitecell count can happen in every TYPICAL if investigated.

Posted by: captainjohann at July 24, 2006 08:54 AM

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