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

ar to the rationale for the aforementioned, Memorial Sloan-Kettering study, this Phase 1 trial was designed to evaluate toxicity and preliminary efficacy of the combination of docetaxel plus QUADRAMET administered sequentially in advanced HRPC.

Preliminary data was published for 10 patients who received repeated doses of the combination of QUADRAMET (at the full FDA-approved doses of 1.0 mCi/kg every 12 weeks for a maximum of two cycles) and escalating doses of docetaxel (at doses up to 75 mg/m(2) every three weeks). All patients had bone metastases and all symptomatic patients (seven of seven) had improvement of pain. Median baseline PSA was 77 ng/ml and four of 10 patients achieved a 50% decline that lasted for four or more weeks.

The authors concluded that the data suggest that the combination of QUADRAMET and docetaxel may be administered simultaneously at the full approved doses in extensively pretreated HRPC patients with acceptable toxicity and significant activity.

"A Phase 2 trial of docetaxel and samarium in patients with bone metastases from castration-refractory prostate cancer (CRPC)" by Laplanche, A. et al. (Abstract No. 5122, Poster No. G4)

In a prospective, Phase 2 investigator-sponsored trial investigators reported on long-term pain responses, disease progression and survival in patients treated with a combination of QUADRAMET and docetaxel/estramustine. Forty-three patients with CRPC were administered docetaxel (70 mg/m(2) per cycle) on three week intervals for three cycles which was followed by a weekly dosing schedule of docetaxel (20 mg/m(2) per cycle for six cycles) during which a single dose of QUADRAMET (1.0 mCi/kg) was administered in combination with the first dose of docetaxel. The authors reported a median prostate specific antigen (PSA) progression-free survival rate of seven months, a median survival of approximately 30 months, and concluded the combination was feasible, well tolerated, and associated with a
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