NeoRx submits plan to FDA for registration of Skeletal Targeted Radiotherapy clinical program.NeoRx Corporation, Seattle, WA, announced it has submitted to the US Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) its proposed pivotal clinical program for registration of Skeletal Targeted Radiotherapy (STR STR abbr. synchronous transmitter receiver ). The company says it is developing STR for use with high-dose chemotherapy (melphalan) and autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism. au·tol·o·gous adj. 1. stem cell transplantation Stem Cell Transplantation Definition Stem cells are basic human cells that reproduce (replicate) easily, providing a continuous source of new, sometimes different types of cells. for treatment of patients with multiple myeloma. Subject to the authorization, NeoRx plans to begin patient enrollment in early 2004. NeoRx reports data from Phase I/II clinical trials show that STR in combination with melphalan at the doses proposed for the clinical program achieved response rates of approximately 40%. The company says standard and recently approved chemotherapeutics for non-transplant regimens for multiple myeloma generally provide complete response rates of less than 5%. Contact: Melinda Kile - (206) 286-2501, Web site - www.neorx.com. |
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