Theseus Imaging is withdrawing its investigational new drug (IND) application to the Food and Drug Administration for its Hynic-Annexin V product candidate. The product was slated for testing in protocols for the study of the biodistribution and timing of tumor uptake in subjects with lung cancer, non-Hodgkin’s lymphoma, and breast cancer.
The firm, a subsidiary of Chatsworth, CA-based radiopharmaceutical developer North American Scientific, plans to resubmit a new filing in the next few months that will provide additional data requested by the FDA. According to the company, the FDA is now requiring development of immunology assays related to the company’s human recombinant protein, and the inclusion of data characterizing these assays in the IND submission. Clinical studies will continue in Europe, said president and CEO of North American Scientific, Michael Cutrer.
By AuntMinnie.com staff writersJanuary 21, 2003
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