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MGI Pharma Summarizes Data Presented at the 2007 American Society,of Clinical Oncology (ASCO) Annual Meeting

epitant given only on Day 1 for the prevention of acute and delayed CINV in patients receiving MEC were presented in a poster session on Saturday, June 2, 2007.

Forty-one patients (40 female, 1 male) with solid tumors received a 1-day, 3-drug regimen of intravenous Aloxi 0.25 mg, oral dexamethasone 20 mg and aprepitant 285 mg prior to their first cycle of chemotherapy. Endpoints of the study included complete response (no emesis or rescue medication), no emesis, and no significant nausea (Visual Analogue Score (VAS; 0-100) less than 25) on Day 1, during the delayed period of Days 2-5, and during the overall period of Days 1-5.

On Day 1, 100% of patients had no emesis and at least 95% of patients had no emetic episodes in the delayed and overall time periods. A complete response was demonstrated in 75% of patients on Day 1 and in 67% of patients in the delayed time period. Based on VAS, the majority of patients had no significant nausea in the acute, delayed or overall phases. The most commonly observed adverse events were headache and fatigue.

Phase 3 Results of Aloxi in Pediatric Patients

The results of a phase 3, multicenter, randomized, double-blind study to assess the safety, efficacy and pharmacokinetics of single intravenous doses of Aloxi in pediatric patients were presented in a poster session on Sunday, June 3, 2007. Sixty patients (2-17 years of

age) were randomized to receive either 3 mcg/kg or 10 mcg/kg with a maximum total dose of 0.25 mg and 0.75mg, respectively, prior to moderately (n=21) or highly (n=39) emetogenic chemotherapy. Twelve additional patients, age 28 days-23 months, were studied in open-label design at the same doses. The majority of patients had received previous chemotherapy. Day 1 complete response (CR: no emetic episodes and no rescue medication) rates of 37.1% (CI, 22.0-55.1%) and 54.1% (CI, 37.1-70.2%) were reported in the 3 mcg/kg (n=35) and 10 mcg/kg

(n=37) groups, respectively. The perce
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