Pharmaceutical firm Boston Life Sciences has filed an investigative new drug (IND) application with the Food and Drug Administration for its Fluoratec technetium-based radiopharmaceutical. The Boston-based firm plans to study the safety and efficacy of the agent in diagnosing Parkinson's Disease (PD) and Attention Deficit Hyperactivity Disorder (ADHD).
Fluoratec is a second-generation dopamine transporter (DAT) imaging agent, and was developed by the same Boston Life Sciences R&D program that created Altropane, a 123I-labeled radioimaging agent also targeted for diagnosis of PD and ADHD. Phase III trials for Altropane for diagnosing PD have been completed, while phase II trials for the diagnosis of ADHD have just begun, according to the firm.
Fluoratec has an affinity and specificity for DAT even greater than Altropane, according to the company. Boston Life Sciences also claims that the use of technetium as the gamma emitter in Fluoratec will allow the company to sell cold (non-labeled) kits, which can be easily and quickly labeled on-site at the hospital immediately prior to use. The Fluoratec IND was filed under the sponsorship of Dr. Alan Fischman, chief of nuclear medicine at Massachusetts General Hospital in Boston.
By AuntMinnie.com staff writersMay 16, 2000
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