HOUSTON and OMAHA, Neb., (June 3, 2013) – ApoCell, Inc. and Transgenomic, Inc. (OTCBB: TBIO) today announced the results of a research collaboration with the University of Texas MD Anderson Cancer Center that coupled ApoCell’s ApoStream™ platform for isolating circulating tumor cells (CTCs) with Transgenomic’s ICE COLD-PCR technology to detect signature mutations in CTCs isolated from the blood of lung cancer patients.
A poster entitled “Characterization and identification of specific EGFR mutations in circulating tumor cells (CTCs) isolated from non-small cell lung cancer patients using an antibody independent method, ApoStream”, co-authored by investigators at MD Anderson, ApoCell, and Transgenomic, will be presented at the 2013 ASCO annual meeting today. The study led by Drs. John Heymach and Hai Tran of MD Anderson focused on characterization and identification of specific EGFR mutations in CTCs isolated from 32 non-small cell lung cancer patients and 3 healthy volunteers with the goal of determining the concordance of mutations between blood and tumor tissue.
CTCs have long been known to exist in cancer patients’ blood and clinical correlations have been established between CTC counts and disease progression. “This study shows that lung cancer tumor cells can be identified in blood using a novel approach that does not rely on antibody binding to specific surface markers, and that by using the ultra-sensitive ICE COLD-PCR technology, we can detect mutations in these cells,” said Dr. Heymach, chair, Department of Thoracic/Head and Neck Medical Oncology, MD Anderson. “We believe these are important steps forward towards the goal of being able to use blood tests to help guide cancer therapies and understand drug resistance.”
“ApoCell has incorporated ApoStream™ into a number of ongoing early and late stage clinical trials as part of the company’s service offering,” said Darren Davis, ApoCell president and CEO. ApoStream™ has been shown to detect significant quantities of intact CTCs from a wide range of cancer types, enabling more robust downstream analysis for greater understanding of each patient’s disease.
The company plans to commercially launch the technology for research-use-only in 2014. Following the commercial launch of the research-use-only instrument, Davis said, ApoCell plans to continue developing ApoStream™ technology for a clinical point-of-care device that would provide oncologists with more effective monitoring of targeted therapies for various cancer types.
The company’s goal is to launch a clinical instrument in 2016. “We believe ApoStream™ can play a significant role in the evolution of personalized cancer treatment,” Davis said.
This small pilot study demonstrated that ICE COLD-PCR technology was able to detect a number of the mutations in CTCs that were found in matched tumors from the same patient. “Use of the ultrasensitive ICE COLD-PCR technology to detect cancer-associated mutations in CTCs helps clinicians to better understand how the presence of low-level mutations impact response to existing and novel therapies,” said Craig Tuttle, CEO and president of Transgenomic, Inc. “We believe results of this study and others will contribute to the optimal selection of therapy for cancer patients,” Tuttle said.
Transgenomic has expanded its range of ICE COLD-PCR gene mutation identification kits to cover additional gene mutations that are important in cancer and associated with drug response. These research products continue to be targeted to clinical and research communities worldwide. The company is also completing a review of future diagnostic applications and utility of the ICE COLD-PCR technology and products for commercial applications.
ApoStream™ is antibody independent and utilizes a process known as dielectrophoresis (DEP) field-flow assist. The technology employs a non-uniform electrical field at specific frequencies to separate viable cancer cells from normal blood cells by relying on a cancer cell’s unique form and structure, rather than surface antigen expression. The device has been utilized in a number of early and late stage clinical trials and has been effective in CTC selection from human blood across a wide range of cancer types.
About ICE COLD-PCR
ICE COLD-PCR, “Improved and Complete Enrichment COamplification at Lower Denaturation” temperature, that Transgenomic has developed in collaboration with the laboratory of Mike Makrigiorgos, Ph.D., at the Dana Farber Cancer Institute, selectively amplifies mutant DNA by exploiting differences in denaturation temperatures between mutant DNA duplexes and normal “wild-type” DNA duplexes. ICE COLD-PCR is able to detect mutant DNAs occurring in as low as 0.01% frequency in a majority of wild-type (normal) populations and is ideal for standard Sanger, NG Sequencing, digital PCR and other technologies, which results in improvements in “limits of detection” (LOD) of 400- and 100-fold, respectively, for the sequencing platform. In addition, the technique is not specific to a single mutation within a DNA target, but enables detection of any mutation in a given region of DNA. The approach allows clinicians to use small amounts of sample for genetic analysis or non-invasive sample collection methods such as a blood draw to enable detection of mutant DNA species present in serum or plasma, circulating tumor cells, urine, or bronchial lavage specimens. DNA can also be analyzed from fine needle aspirates, core-biopsies, or directly from tumors. Since ICE COLD-PCR can detect low level mutations in samples where an abundance of “normal” DNA exists, such as blood, repeated assessments of a patient’s disease status can be determined without having to take additional biopsies from the tumor.
About Transgenomic, Inc.
Transgenomic, Inc. (www.transgenomic.com) 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 a global leader in cardiac genetic testing with a family of innovative products, including its C-GAAP test, designed to detect gene mutations which that indicate cardiac disorders or which that 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.
Based in Houston, Texas, ApoCell (www.apocell.com) is a privately-held specialty clinical research company. Founded in 2004, the firm is a leader in molecular biomarker detection and analysis, leveraging its expertise in the areas of oncology, diabetes, molecular diagnostics and drug development to measure biomarker signatures in clinical trial subjects. The company’s proprietary methods provide early proof of mechanism of action and monitor the effectiveness of various types of drugs by measuring biomarker expression patterns in biopsies, blood and rare cell types. The company’s facilities are CLIA-certified and compliant with applicable FDA regulations. Since inception, the company has participated in over 140 Phase I, II, and III clinical cancer drug trials for more than 80 sponsor clients worldwide.
For Transgenomic: Forward-Looking 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 the impact of the results of the Company’s research study with ApoCell, Inc. and the University of Texas MD Anderson Cancer Center, the ability to isolate lung cancer tumor cells from blood, and the opportunity to grow the Company’s clinical laboratories and diagnostic tools businesses. The known risks, uncertainties and other factors affecting these forward-looking statements include those described from time to time in Transgenomic’s filings with the Securities and Exchange Commission , including the Company’s Annual Report on Form 10-K for the year ended December 31, 2012. 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. 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.
Kenna Anderes, Ph.D.
VP Scientific Affairs
Public Relations Contact
David Pitts, 212-600-1902
Investor Relations, 402-452-5416