Cancer therapeutics development company files IND for metastatic breast cancer.

2004 AUG 5 - (NewsRx.com & NewsRx.net) -- NeoRx Corporation (Nasdaq:NERX) announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a phase II clinical study of STR (skeletal targeted radiotherapy) in patients with breast cancer that has metastasized to the bone.

Researchers at Houston-based M.D. Anderson Cancer Center have conducted a small investigator-initiated phase I dose-escalation study of STR in patients with stage IV breast cancer involving osseous (bony) metastases. Six patients were administered STR as a single agent, followed by autologous (self-donor) blood stem cell transplantation. Two of the six patients remain alive, without progression of their disease for over five years post-transplant. The median time to disease progression in the other four patients was 220 days (range:92 to 370 days). Disease relapse in these four patients occurred in tissues outside the bone.

"We are encouraged by the results from this first small study of STR in breast cancer patients with osseous metastases," said Richard E. Champlin, MD, chair of the Department of Blood and Marrow Transplantation at M.D. Anderson Cancer Center. "Two patients in the study have survived more than five years without disease recurrence, which is rarely achieved with any other therapy. These results suggest that STR may be effective in ablating cancerous lesions in the tissues it specifically targets, the bone and bone marrow."

Champlin added, "It also should be noted that STR was used as a single agent in this early study, without high-dose chemotherapy as part of the transplant ...