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New Data for Cytogen's QUADRAMET Reported at Annual ASCO Meeting

-limiting toxicity (DLT) was evaluated based on the first cycle of treatment and DLT was not reached in 21 patients who received the combination regimen including patients who received the full FDA approved doses of each agent. Further, all patients' platelet and neutrophil counts recovered to protocol defined levels and times allowing for re-treatment after cycle one. At baseline, median Gleason Score was eight, median PSA values were 162 ng/ml and 43% of patients had previously received taxane-based chemotherapy. Following treatment, 12 out of 21 patients achieved a 50% or greater decline in PSA. Data on progression-free survival are pending.

The authors concluded that repetitive dosing of QUADRAMET and docetaxel was feasible and well-tolerated. Clinically significant hematologic toxicity was rare and does not appear to be related to dose or disease burden. Plans are underway for a multi-center Phase 2 study with Memorial Sloan-Kettering Cancer Center and other leading prostate cancer centers.

"With bone pain representing a significant quality-of-life concern for patients with metastatic prostate cancer, we wanted to see if we could combine QUADRAMET, an FDA-approved drug to treat bone pain, with docetaxel, an FDA-approved drug to treat late stage prostate cancer, and administer both at their respective, FDA-approved therapeutic doses without compromising patient safety," explained Michael J. Morris, M.D., an oncologist specializing in prostate cancer at Memorial Sloan-Kettering Cancer Center. "The Phase 1 data demonstrate that repeated doses of QUADRAMET are safe and do not appear to impair the effective delivery of docetaxel in most patients."

"Phase 1 trial with combination of docetaxel (D) plus samarium-13 (Sm 153) in patients (pts) with hormone refractory prostate cancer (HRPC)" by Sinibaldi et al. Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD (Abstract No. 15547, published in the ASCO proceedings)

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