PIK3CA Gene Patent for Predicting Response to Targeted Therapy Issued – Exclusively Licensed to Transgenomic

Posted: June 11, 2012 at 3:19 pm


Transgenomic, Inc. (TBIO) announced that the US Patent and Trademark Office has issued patent number US 8,137,919 entitled Method of Determining the Sensitivity of Cancer Cells to EGFR Inhibitors including Cetuximab, Panitumumab and Erlotinib. The patent was exclusively licensed to Transgenomic by the Montefiore Medical Center (Bronx, NY, US) and includes all tumor types and targeted therapies that may be influenced by PIK3CA mutation status.

Montefiore inventors Drs. Sanjay Goel and John Mariadason have demonstrated that key mutations in the gene PIK3CA are powerful predictors for the efficacy of EGFR-targeted therapies such as cetuximab (Erbitux), panitumumab (Vectibix) and erlotinib (Tarceva). These findings were published in the June 2012 issue of Clinical Colorectal Cancer by the same researchers and have been reproduced in other independent studies.

Assays using Transgenomics proprietary SURVEYOR Scan, REVEAL ICE COLD-PCR and BLOCker-Sequencing for complete detection of PIK3CA mutations have been developed. The extremely high sensitivity of Transgenomics REVEAL ICE COLD-PCR technology enables the use of virtually any sample type including blood and circulating tumor cells. Non-invasive testing allows for more frequent and accurate profiling of a cancer as it responds to treatment and gains additional mutations.

The recent issuing of this important patent is a significant milestone in the continued development of our genetic biomarker intellectual property portfolio, said Craig Tuttle, CEO of Transgenomic. Since exclusively licensing this patent we have been able to effectively apply our high sensitivity mutation detection technologies, such as SURVEYOR Scan, REVEAL ICE COLD-PCR and BLOCker-sequencing, to PIK3CA assays in order to be able to detect genetic variations in very low mutant load samples, such as plasma, serum and circulating tumor cells.

Tuttle added that, The number of genes associated with the effectiveness of targeted cancer treatments is increasing; our strategy is to provide a complete portfolio of best-in-class kits for clinically relevant mutations using our proprietary and extremely sensitive technologies. These assays will also be available through our CLIA and Pharmacogenomics laboratories to support clinicians and pharmaceutical research and trials.

About Transgenomic

Transgenomic, Inc. (www.transgenomic.com) is a global biotechnology company advancing personalized medicine in cancer and inherited diseases through its proprietary molecular technologies and world-class clinical and research services. The Company has three complementary business divisions: Transgenomic Pharmacogenomic Services is a contract research laboratory that specializes in supporting all phases of pre-clinical and clinical trials for oncology drugs in development. Transgenomic Clinical Laboratories specializes in molecular diagnostics for cardiology, neurology, mitochondrial disorders, and oncology. Transgenomic Diagnostic Tools produces equipment, reagents, and other consumables that empower clinical and research applications in molecular testing and cytogenetics. Transgenomic believes there is significant opportunity for continued growth across all three businesses by leveraging their synergistic capabilities, technologies, and expertise. The Company actively develops and acquires new technology and other intellectual property that strengthen its leadership in personalized medicine.

Forward-Looking Statements

Certain statements in this press release constitute forward-looking statements of Transgenomic 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 Transgenomic's filings with 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. All information in this press release is as of the date of the release and Transgenomic does not undertake any duty to update this information, including any forward-looking statements, unless required by law.

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PIK3CA Gene Patent for Predicting Response to Targeted Therapy Issued – Exclusively Licensed to Transgenomic

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