Transgenomic and NYU Collaborate on Lung Cancer Study

Transgenomic, Inc. announced that it has begun a collaboration with NYU Langone Medical Center to employ its ultra-high sensitivity ICE COLD-PCR mutation detection technology to better understand molecular events that drive non-small cell lung cancer and impact response to existing and novel therapies. The joint study will focus on the detection of cancer-associated mutations in the blood of patients with surgically operable early stage lung cancer, the stage where it is most curable and amenable to treatment.

Rare circulating tumor cells (CTCs) will be isolated from the blood of approximately 200 patients using Transgenomic's licensed CTC capture ScreenCell® devices before and following surgery to determine if the numbers of CTCs change in response to treatment or are associated with disease recurrence or progression. DNA from these cells will be analyzed by ICE COLD-PCR for the presence of mutations that have been shown to affect response to targeted drugs; tumor-derived cell-free DNA (cfDNA) found in blood samples will be analyzed similarly. The molecular profile of cfDNA and DNA isolated from CTCs will then be compared to that of the primary lung tumor to better understand characteristics of cells that escape the tumor and are thought to be responsible for metastasis. Mutations conferring drug resistance can also be measured from CTCs and cfDNA and may indicate the re-emergence of disease before clinical symptoms appear, at a time when the administration of alternative therapies may forestall progression.

"Our ICE COLD-PCR technology is ideally suited to monitor patients' disease activity and response to drugs in real time", said Craig Tuttle, Chief Executive Officer of Transgenomic, Inc. "Detecting cancer mutations from CTCs and DNA present in blood samples will allow physicians to intervene before clinical symptoms of disease recurrence appear and make routine 'blood biopsies' a reality."

The study will be jointly overseen by Dr. Harvey I. Pass, M.D., the Stephen E. Banner Professor of Thoracic Oncology and Vice-Chair Research, Department of Cardiothoracic Surgery and Division Chief, General Thoracic Surgery, NYU Langone Medical Center, and by Drs. Marcia Lewis, Vice President of Biomarker Development and Katherine Richardson, Vice President of R&D at Transgenomic, Inc. Transgenomic will provide funding for support staff at NYU Langone Medical Center for the duration of the study, which is estimated to take between one and two years.

"The NYU Langone Thoracic Oncology Laboratory is extremely excited about this collaboration, which was facilitated by the Early Detection Research Network of the NCI/NIH", said Dr. Pass. "It will enable a greater understanding of the role of CTCs in early lung cancer in a prospectively accrued, large number of patients. Moreover, the ability to detect tumor-identical mutations in CTCs from lung cancer patients could open up a wealth of possibilities for non-invasively prescribing the appropriate therapy for the right patient, especially now when so many targetable mutations are being discovered in the disease."

This study builds on Transgenomic's recently announced collaboration at MD Anderson Cancer Center that also employs ICE COLD-PCR to characterize tumor-derived DNA in blood and DNA isolated from CTCs from patients with a variety of cancers to choose therapies shown to target specific mutations. Transgenomic is negotiating additional collaborations at major cancer centers in the US to extend the validation of its ICE COLD-PCR technology.

In June, the Company announced the commercial launch of its REVEAL® Kits which utilize ICE COLD-PCR to detect mutations in a variety of cancer-associated genes.