Clinical Data Achieves Validation of Genetic Biomarker for Determining Risk of Clozapine Induced Agranulocytosis
Wednesday April 19, 7:00 am ET
NEWTON, Mass.--(BUSINESS WIRE)--April 19, 2006--Clinical Data, Inc. (NASDAQ:CLDA - News):
Clinically Validated Gene in HLA Complex Basis for First Genetic Risk Assessment Tool for Clozapine-Induced Agranulocytosis (CIA), a Serious Adverse Drug Reaction
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 - News), 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 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 (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 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 schizophrenia. It is acknowledged as the "gold standard" for schizophrenia treatment. However, concerns regarding the side effects of clozapine have negatively impacted its use. In a new study of schizophrenia drugs funded by the National Institute of 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, "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 disease afflicting 1% of the population across varied geographical regions and is characterized by delusional beliefs, auditory hallucinations, disorganized 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... |
