SBIR Phase II: PET Radiotracer Synthesis

This Small Business Innovation Research Phase II project develops positron emission tomography (PET) imaging products to manage neurodegenerative disorders, cancer, and cardiovascular disease. PET is now a key diagnostic and management tool in oncology, and compounds labeled with [18F]-fluoride provide optimal signal to noise ratios and resolution in medical imaging applications. Ground Fluor Pharmaceuticals (GFP) developed proprietary single-step fluorination technology that allows [18F]-labeled medicines to be prepared efficiently from cyclotron-produced [18F]-fluoride. Under this Phase II research project GFP will apply its new technology to produce the imaging agent 6- [18F]fluoro-L-DOPA (FDOPA), a compound useful in diagnosing Parkinson's disease and in cancer imaging, that is not currently readily available because of the difficulty in its production. GFP will scale-up and manufacture pharmaceutical grade ALPDOPA (GFP's precursor to FDOPA) under pharmaceutical cGMP conditions, and offer this material for research studies and for clinical imaging. GFP will develop an FDA drug master file and will provide technical and regulatory assistance to cyclotron pharmacy customers adopting GFP's technology for commercial production of FDOPA. In addition to helping to bring this valuable imaging agent to market, GFP will assist academic and pharmaceutical research groups in the development of new [18F]- fluorinated imaging products. The broader impact/commercial potential is to expand the scope and utility of PET as medical diagnostic tool, thereby improving treatment and management of serious medical problems. Although [18F]-fluoride possesses, perhaps, the most advantageous properties for imaging, is relatively inexpensive, and is widely available, it is difficult to incorporate into medicines for imaging. GFP has developed a general enabling technology that uses the relatively inexpensive and widely available form of [18F]-fluoride to create new molecular imaging agents to advance personalized medicine. This technology, and the compounds it creates, will provide the physician with new opportunities to diagnose, assess, and more efficiently treat unmet medical needs. The manufacturing technology developed here is a broad platform applicable to the preparation of a wide range of new imaging agents. The commercial potential of PET imaging is significant; the worldwide market for PET is expected to grow to $15 billion by 2015.