July 31, 2007
Siemens Medical Solutions announced that it has been granted an Investigational New Drug (IND) Exemption by the 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 located in New York City, 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.
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 a molecular imaging technique like PET-CT, 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 diseases – 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, Single-Photon Emission Computed Tomography (SPECT) or SPECT-CT. 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, are 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 responses and quickly adjust therapeutic approaches to arrive at optimum outcomes.