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Phase 1 Trial of Quadramet in Combination with Velcade Shows Positive Results
Date:2/11/2009

EUSAPharma (formerly Cytogen) Posts Positive Phase I Report from Trial of Quadramet in Combination with Velcade for the Treatment of Relapsed or Refractory Multiple Myeloma.

LOS ANGELES, Feb. 11 /PRNewswire/ -- Quadramet (153 Samarium-lexidronam) is a radioactive medication that targets the bone, specifically bone cancer, and is used to treat pain caused by cancer that has metastasized or spread to the bone. Velcade (bortezomib) is approved for the treatment of multiple myeloma alone and in addition to chemotherapy. Preclinical studies have reported that the combination of Velcade with Quadramet is much more effective than either drug alone in its anti-myeloma effects.

Published in the journal Clinical Cancer Research, this US-based Phase 1 study included 39 multiple myeloma patients at three clinical oncology sites. Noted oncologist and myeloma specialist, Dr. James R. Berenson was Principal Investigator.

The Phase 1 study evaluated the combination of radiotherapy, a drug that targets bone and bone marrow, with Velcade in order to determine efficacy and safety among patients who had been previously treated. This groundbreaking study marks the first attempt to evaluate targeted radiotherapy with the potent myeloma drug Velcade for myeloma patients.

Dr. Berenson reports, "By using less Velcade than in previous studies along with Quadramet, responses were observed even among patients who were failing Velcadebased therapy. Some patients achieved complete responses with this novel combination treatment in this Phase 1 study. Patients were given 4 doses of Velcade every 8 weeks instead of the standard 4 doses every 3 weeks, and we observed much less peripheral neuropathy with this less intensive schedule. Overall this was a very well tolerated treatment for the patients."

James R. Berenson, MD is a 25 year veteran in the field of oncology wi
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SOURCE Oncotherapeutics
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