July 17, 2009 – PETNET Solutions, a wholly owned subsidiary of Siemens Medical Solutions USA, announced today that it is a registered supplier of investigational 3’Deoxy-3’[18F] Fluorothymidine (F-18 FLT) to the Society of Nuclear Medicine’s Clinical Trial network.
This was made possible via a cross reference from Siemens Molecular Imaging/PETNET’s Drug Master File (DMF) to the SNM’s centralized IND.
This is in addition to the National Cancer Institute’s previous filing of a cross-reference letter to the same Type II Drug Master File that Siemens submitted to the U.S. Food and Drug Administration for its investigational 3’Deoxy-3’[18F] Fluorothymidine (F-18 FLT). The cross reference allows F-18 FLT to be produced and used by any principle investigator in an NCI or SNM multi-center clinical trial.
The imaging biomarker will also be available to investigators outside of the NCI and SNM trials, if they receive independent FDA approval of an IND or appropriate approval, such as a local Radioactive Drug Research Committee (RDRC) approval. F-18 FLT has been used in studies monitoring the proliferative activity of cancer cells and it is currently being used in clinical trials at several research sites. This cross reference to Siemens Molecular Imaging/PETNET’s DMF provides the medical community wider access to FLT by leveraging Siemens biomarker technology and the industry’s largest network of PET biomarker production facilities.
For more information: www.siemens.com/healthcare