Transgenomic is Awarded NIH STTR Grant for Pancreatic Cancer Research

Transgenomic is Awarded NIH STTR Grant for Pancreatic Cancer Research

today announced it has been awarded a $100,000 Small Business Technology Transfer Program (STTR) Phase I Grant by the National Institutes of Health’s National Center For Advancing Translational Sciences. This grant, entitled “Early Detection of Pancreatic Cancer Using ICE COLD-PCR”, is a joint project with Tony Hollingsworth, Ph.D., University of Nebraska Medical Center, who heads a leading research team studying pancreatic cancer and other diseases of the pancreas, such as pancreatitis.

Pancreatic cancer is difficult to diagnose at an early stage. In the disease’s late stage response to therapy is poor with an average survival of six months after diagnosis and a five-year survival rate of less than 4 percent. This project aims to develop a highly sensitive genetic test that can detect pancreatic cancer biomarkers in blood or urine, enabling much earlier diagnosis and more effective treatment.

With Dr. Hollingsworth’s team, Transgenomic will test the application of its proprietary ICE COLD-PCR technology to the high sensitivity detection of key mutations in pancreatic cancer in pancreas, urine and blood.

If promising results are obtained from these Phase I studies, a Phase II STTR application will be submitted to include more comprehensive studies of ICE COLD-PCR detection of DNA mutations associated with early and late stage pancreatic cancer in humans. This could ultimately lead to a simple, highly sensitive diagnostic assay for the early detection of pancreatic ductal adenocarcinoma.

“This successful peer-reviewed grant award reinforces the promise of our ICE COLD-PCR technology in being able to deliver high-sensitivity genetic information to support the treatment of oncology patients, such as those suffering from pancreatic cancer,” said Craig Tuttle, Chief Executive Officer of Transgenomic. “Both the financial support of the NIH and working with prominent cancer research groups, such as Dr. Hollingsworth and his team, will accelerate the development of our high-sensitivity cancer diagnostic assays.”

“This grant funds research that builds upon our ongoing collaboration with Transgenomic, which is also facilitated by our active participation in the Early Detection Research Network of the National Cancer Institute,” said Dr. Hollingsworth. “This research project is an excellent example of how an academic-industrial collaboration can rapidly determine the potential utility of a promising diagnostic or prognostic assay for one of the most insidious diseases – pancreatic cancer. It is highly commendable that Transgenomic, a small business, is willing to attack the difficult problem of diagnosing pancreatic cancer.”

ICE COLD-PCR technology, exclusively licensed by Transgenomic for DNA sequencing analysis, was developed in collaboration with the Dana-Farber Cancer Institute and is supported by multiple validation studies confirming reproducible mutation detection at very high sensitivity – up to 1,000 to 10,000 times more sensitive than traditional sequencing and PCR techniques. The technology is also being evaluated in an ongoing study with The University of Texas MD Anderson Cancer Center to analyze DNA isolated from circulating tumor cells (CTCs).

Transgenomic, Inc. () is a global biotechnology company advancing personalized medicine in cardiology, oncology, and inherited diseases through its proprietary molecular technologies and world-class clinical and research services. The Company is the global leader in cardiac genetic testing with a family of innovative products, including its flagship C-GAAP test, designed to detect gene mutations which indicate cardiac disorders, or which can lead to serious adverse events. Transgenomic has three complementary business divisions: Transgenomic Clinical Laboratories, which specializes in molecular diagnostics for cardiology, oncology, neurology, and mitochondrial disorders; Transgenomic Pharmacogenomic Services, a contract research laboratory that specializes in supporting all phases of pre-clinical and clinical trials for oncology drugs in development; and Transgenomic Diagnostic Tools, which 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 strengthens its leadership in personalized medicine.

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.

Research reported in this press release is supported by the National Center For Advancing Translational Sciences of the National Institutes of Health under Award Number R41TR000374. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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