Radiopharmaceutical developer North American Scientific's Theseus Imaging subsidiary has resubmitted an investigational new drug (IND) application to the Food and Drug Administration for its Hynic-Annexin V molecular imaging agent. Hynix-Annexin V is intended to provide early assessment of anti-cancer therapy on a patient-by-patient basis, NAS said.
The company said that phase II studies under this IND submission are designed to provide information about product safety, biodistribution, imaging technique, and optimal timing of imaging after chemotherapy in patients with non-small cell lung cancer. The studies should also provide a preliminary assessment of the predictive value of the agent at various times following a single course of chemotherapy.
A previous IND submission for Hynic-Annexin V was withdrawn in January to allow NAS to develop certain immunological assays requested by the FDA, according to the Chatsworth, CA-based company.
By AuntMinnie.com staff writers
May 9, 2003
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