Siemens Medical Solutions announced today that it has been granted an Investigational New Drug (IND) Exemption by the U.S. Food and Drug Administration (FDA) to conduct a Phase I clinical trial of [F-18] 3'-fluoro-3'- deoxythymidine (FLT), a molecular imaging biomarker that has shown promise in monitoring the proliferation of cancer cells, which could help physicians quickly determine the effectiveness of cancer therapies.
To broaden the scope of FLT research, Siemens will support the FLT Phase I clinical trial that will be conducted at Memorial Sloan-Kettering Cancer Center, with whom Siemens has signed a research collaboration agreement focused on the codevelopment of imaging biomarkers that will be used in PET imaging. Through these collaborative efforts Siemens intends not only to make FLT more readily accessible to research and academic institutions for further study, but also to continue research into new more target specific imaging biomarkers for PET.
“This research further demonstrates Siemens’ commitment to advancing molecular medicine by working with the world’s leading medical institutions to develop targeted imaging agents that will pave the way for more personalized therapies,” said Michael Reitermann, Head of Molecular Imaging at Siemens Medical Solutions. “We look forward to working with our colleagues at Memorial Sloan-Kettering to enable leading-edge FLT research that we anticipate will bring us closer to realizing its potential in the early assessment of cancer therapies.”
The significance of FLT is that it may be able to allow researchers and physicians to detect the rate of the proliferation of cancerous cells through molecular imaging techniques, such as PET•CT (positron emission tomography•computed tomography), by enabling visualization of key steps in the replication of DNA, which precedes cell division. By enabling the imaging of the biological processes within cancer cells, FLT could help physicians to personalize cancer therapies by more quickly assessing cancer therapies, avoiding ineffective therapies and determining the most appropriate treatment for an individual patient.
Molecular imaging biomarkers – imaging agents that characterize biological processes and disease – enable the biological mechanisms of disease to be identified and understood. Once imaging biomarkers bind to the diseased cells or tissues, they cause them to “light up” when scanned using PET•CT or SPECT•CT (Single-Photon Emission Computed Tomography). Results may help physicians determine personalized therapies for patients by pinpointing the active pathways in the disease progression. Imaging biomarkers not only enable early diagnosis, but also allow the measurement of how well certain therapies, such as prescription drugs, chemotherapy and radiation therapy, may be working by measuring the impact of treatments on the disease indicators. This may aid the development of new therapies, and enable clinicians to non-invasively assess therapeutic success and quickly adjust therapeutic approaches to arrive at optimum outcomes.
Siemens Medical Solutions of Siemens AG (NYSE: SI) is one of the world’s largest suppliers to the healthcare industry. The company is known for bringing together innovative medical technologies, healthcare information systems, management consulting, and support services, to help customers achieve tangible, sustainable, clinical and financial outcomes. Recent acquisitions in the area of in-vitro diagnostics – such as Diagnostic Products Corporation and Bayer Diagnostics – mark a significant milestone for Siemens as it becomes the first full service diagnostics company. Employing more than 41,000 people worldwide and operating in over 130 countries, Siemens Medical Solutions reported sales of 8.23 billion EUR, orders of 9.33 billion EUR and group profit of 1.06 billion EUR for fiscal 2006 (Sept. 30). Further information can be found by visiting www.siemens.com/medical.