Radiotherapy pharmaceutical developer NeoRx has filed an investigational new drug (IND) application with the Food and Drug Administration for a phase II clinical study of its Skeletal Targeted Radiotherapy (STR) product in patients with breast cancer that has metastasized to the bone, according to the Seattle-based vendor.
In the first phase of the clinical trial, conducted at the M.D. Anderson Cancer Center in Houston, two of the six patients from the small investigator-initiated phase I dose-escalation study of STR remain alive, without progression of their disease for more than five years post-transplant, NeoRx said.
The STR product is composed of a bone-targeting molecule, DOTMP, in a stable complex with the radionuclide holmium-166. The firm said it would be working with the FDA to finalize the protocol for a single-agent phase II trial of STR in breast cancer patients with bone metastases, in anticipation of beginning the study in the first half of 2005.
By AuntMinnie.com staff writersJuly 6, 2004
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