Transgenomic And Power3 Medical Report Identification Of Abnormal Serum Proteins In Parkinson's Disease

Main Category: Parkinson's Disease
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 03 Sep 2009 - 2:00 PDT

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Transgenomic, Inc. (OTC Bulletin Board: TBIO) and Power3 Medical Products, Inc. (OTC Bulletin Board: PWRM) announced the advance on-line publication of a clinical research paper entitled "Abnormal Serum Concentrations of Proteins in Parkinson's Disease" in the scientific journal Biochemical and Biophysical Research Communications. The study demonstrates the usefulness of a protein biomarker panel to distinguish Parkinson's disease (PD) patients from age-matched normal controls independent of the severity of symptoms, using clinical blood serum samples.

The analytic technology forms the basis for the NuroPro(R)PD test for PD being commercialized by Transgenomic as per a licensing/collaboration agreement with Power3 Medical signed in early 2009. The publication of the peer-reviewed article is a significant validation milestone in the ongoing clinical development of the NuroProPD diagnostic assay.

The article describes the use of analytically validated quantitative 2D gel electrophoresis to identify protein biomarkers for diagnosing PD using serum from routinely collected blood samples. 57 protein biomarkers, which had been discovered using retrospective blood serum samples from various neurodegenerative diseases, were then applied specifically to PD in a prospective clinical investigation using freshly collected blood serum from PD patients and age-matched normal controls. A multi-variate statistical method, stepwise linear discriminant analysis, selected a combination of 21 of the biomarkers as optimal to distinguish PD patients from controls. When applied to the PD samples, the 21-protein set had sensitivity of 92.9% (52 of 56 PD correctly classified) and specificity of 93.3% (28 of 30 controls correctly classified); 15 of 15 patients with mild and 28 of 30 with moderate to severe symptoms were correctly classified, as were all 6 PD samples from an independent site.

"We are enthusiastic about the acceptance of our paper in this established peer-reviewed scientific journal. It represents independent external validation of the clinical data, and so increases the confidence that we have in NuroProPD to be a meaningful tool for the diagnosis of Parkinson's disease, especially early in its course," said Craig Tuttle, CEO of Transgenomic. "We are completing the clinical validation of the assay in our CLIA-certified molecular testing laboratory and will be launching the assay in the very near future."

"In the U.S., there are an estimated 1.5 million individuals with Parkinson's disease. Unfortunately, by the time patients are given a probable diagnosis, many have already suffered substantial and irreparable brain damage, rendering treatment less effective," said Dr. Ira Goldknopf, President and CSO of Power3 Medical and lead author on the paper. "The fact that these results were obtained using fresh blood serum, in the same way that the test will be performed in a clinical diagnostic setting, provides further support for their robustness and their commercial value."

Clinical investigators in the study were Dr. Katerina Markopoulou of the University of Thessaly, Greece, Drs. Marwan Sabbagh and Holly Shill of Banner Sun Health Research Institute, Sun City, Arizona, and Dr. Stanley Appel of the Texas Methodist Health System, Houston.

About Transgenomic, Inc.

Transgenomic, Inc. (OTC BB: TBIO.OB, is a global biotechnology company specializing in high sensitivity genetic variation and mutation analysis, providing products and services in DNA mutation detection and discovery for clinical research, clinical molecular diagnostics and pharmacogenomics analyses. Its product offerings include the WAVE(R) Systems and associated consumables specifically designed for use in genetic variation detection and single- and double-strand DNA/RNA analysis and purification. With broad applicability to genetic research, over 1,450 systems have been shipped to customers in more than 30 countries. The SURVEYOR(R) Mutation Detection Kits and SURVEYOR Check-It Kit provide reagents and protocols for high sensitivity detection of mutations in DNA. In addition, HANABI automated chromosome harvesting systems improve laboratory productivity with consistent quality compared to manual methods for cytogenetic analyses. Service offerings include the Transgenomic Molecular Laboratory, which provides reference laboratory services specializing in molecular diagnostics including Mitochondrial Disorders, Oncology and Hematology, Molecular Pathology and Inherited Diseases. Transgenomic Pharmacogenomic Services is a CRO for pharmacogenomic, translational research and clinical trials.

About Power3 Medical Products, Inc.

Power3 Medical Products, Inc. is a leading bio-medical company engaged in the commercialization of neurodegenerative disease and cancer biomarkers, pathways, and mechanisms of diseases through the development of diagnostic tests and drug targets. Power3 Medical operates a state-of-the-art CLIA certified laboratory in The Woodlands (Houston), Texas.

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.

Source: Transgenomic, Inc