Collaboration with Noted Neurologists to Plan Next Clinical Studies
OMAHA, Neb. and HOUSTON, May 11 /PRNewswire-FirstCall/ -- Transgenomic, Inc. and Power3 Medical Products, Inc. , announced the clinical introduction of the NuroPro(R) AD and NuroPro(R) PD tests for Alzheimer’s and Parkinson’s disease at the 2009 American Academy of Neurology meeting in Seattle, WA. The NuroPro tests help clinicians distinguish patients with Alzheimer’s and Parkinson’s diseases from “normal” individuals and patients with other neurological disorders. The tests, developed by Power3, are a panel of blood serum protein biomarkers evaluated by biostatistical analysis to predict the probability a patient has neurodegenerative disease. This information will help physicians make earlier diagnoses and recommend appropriate follow-up and treatment options for their patients.
Katerina Marcopoulou, M.D., Assistant Professor of Neurology at the University of Thessaly, Greece, gave a platform presentation of Phase I results of a prospective Parkinson’s disease trial of NuroPro PD at the AAN meeting. Her presentation covered data developed as part of the clinical validation of NuroPro PD being conducted at the University of Thessaly. The results demonstrated that NuroPro PD was able to discriminate between Parkinson’s disease patients and age-matched control subjects with a sensitivity of 93% and specificity of 96%. In addition, samples from North American Parkinson’s disease patients were correctly identified with 100% sensitivity when tested against the Greek patient database. Dr. Marcopoulou also presented data correlating blood serum concentrations of some of the key protein biomarkers utilized in the NuroPro PD assay with the severity of Parkinson’s disease as measured by two separate clinical scoring methods.
Through a collaboration/licensing agreement between Transgenomic, which develops and provides molecular diagnostic tests and instruments for genetic analysis, and Power3, independent validation of test results for both Alzheimer’s and Parkinson’s diseases are being conducted with key clinical centers. At the AAN meeting, Power3’s Scientific Advisory Board met to plan the next phase of key validation trials. The Scientific Advisory Board currently includes Stanley H. Appel, M.D. Chair of Neurology at Methodist Neurological Research Institute in Houston, TX, Marwan Sabbagh, M.D., Medical Director of the Banner Sun Health Research Institute in Sun City, AZ and principal investigator of the Alzheimer’s study, Bruce Chase, PhD, Neuroscientist and Professor of Biology at the University of Nebraska, Omaha and Dr. Marcopoulou.
“This is the first formal announcement from Transgenomic and Power3 of the clinical introduction of the NuroPro blood test for Alzheimer’s and Parkinson’s Diseases. The presentation of successful Phase I validation of NuroPro for Parkinson’s disease was performed using blood serum from patients, in the same way that the test will be performed in a clinical diagnostic setting. The statistically significant results achieved in comparing samples from non-diseased age-matched controls to those from mild, moderate, and severe Parkinson’s disease demonstrated the diagnostic capability of NuroPro PD at this prestigious meeting,” said Power 3’s President and Chief Scientific Officer, Dr. Ira L. Goldknopf.
“The agreement with Transgenomic, the progress of the clinical validation achieved to date and the introduction at the AAN meeting are steps toward our goal to be the first to market with clinically relevant diagnostic tests for Alzheimer’s and Parkinson’s diseases,” commented Helen R. Park, CEO of Power3.
Craig Tuttle, President and CEO of Transgenomic, added: “We are excited to see this first key clinical validation milestone for the NuroPro PD assay in Parkinson’s disease announced at a major neurology conference. The observation that we may be able to quantify disease severity may prove instrumental in allowing better therapy selections, as well as having therapy initiated more quickly. We remain committed to launching these assays in our CLIA-certified reference lab before the end of the year.”
About Power3 Medical Products, Inc.
Power3 Medical Products is a leader in bio-medical research and the commercialization of neurodegenerative disease and cancer biomarkers, pathways, and mechanisms of diseases through the development of diagnostic tests and drug targets. Power3’s patent-pending technologies are being used to develop screening and diagnostic tests for the early detection and prognosis of disease, identify protein biomarkers, and drug targets, and its diagnostic tests are targeted toward markets with critical unmet needs in areas including neurodegenerative disease (NuroPro) and breast cancer (BC-SeraPro). Power3 expects to complete phase II clinical validation trials of its blood serum diagnostics for Alzheimer’s and Parkinson’s disease (NuroPro AD and PD), in the fourth quarter of 2009, followed by completion of filing with the FDA. Power3 operates a state-of-the-art CLIA certified laboratory in The Woodlands (Houston), and continues to evolve and enhance its IP portfolio, employing sensitive and specific combinations of biomarkers it has discovered from a broad range of diseases as the basis of highly selective blood-based tests for ALS, Alzheimer’s, and Parkinson’s diseases, breast cancer, and drug resistance.
About Transgenomic
Transgenomic is a global biotechnology company that provides unique products and services for automated high sensitivity genetic variation and mutation analysis. Their offerings include systems, products, discovery and laboratory testing services to the academic and medical research, clinical laboratory and pharmaceutical markets in the fields of Pharmacogenomics and personalized medicine. Specific offerings include WAVE(R) DHPLC Systems, related consumables and assay kits, Cytogenetics automated systems, and Transgenomic Pharmacogenomics and Reference Laboratory Services. Transgenomic Pharmacogenomics and Laboratory Services utilize their technology and expertise to provide a menu of mutation scanning tests for over 700 cancer-associated genes and more than 60 validated diagnostic tests to meet the needs of pharmaceutical and biotech companies, research and clinical laboratories, physicians and patients. For more information about the innovative systems, products and services offered by Transgenomic, please visit: www.transgenomic.com.
Cautionary Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not limited to, those with respect to management’s current views and estimates of future economic circumstances, industry conditions, company performance and financial results, including the ability of the Company to grow its involvement in the diagnostic products and services markets. The known risks, uncertainties and other factors affecting these forward-looking statements are described from time to time in reports to the Securities and Exchange Commission. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. Accordingly, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 with respect to all statements contained in this press release.
CONTACT: Debra Schneider, Chief Financial Officer of Transgenomic, Inc.,
+1-402-452-5400, investorrelations@transgenomic.com
Web site: http://www.power3medical.com/
http://www.transgenomic.com/
