July 14, 2014

Merck reported results for a phase III study of EMEND (aprepitant) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged 6 months to 17 years. In the randomized, double-blind, active-comparator study of 302 participants, patients receiving emetogenic chemotherapy were randomly assigned to receive an EMEND plus ondansetron regimen (n=152) or a control regimen (placebo plus ondansetron) (n=150). The first dose of EMEND (plus ondansetron) was administered on day one of chemotherapy, then subsequently (without ondansetron) later on days two and three. In the study, 51% of patients receiving the EMEND regimen achieved the primary endpoint of complete response in the delayed phase of CINV, versus 26% of those in the control group (p<0.0001). For the secondary endpoints, 66% of patients receiving the EMEND regimen achieved a complete response in the acute phase of CINV, versus 52% of those receiving the control regimen (p=0.0135). In addition, complete response in the overall phase was higher in patients receiving the EMEND regimen versus the control regimen (40% v. 20%, p=0.0002). No vomiting in the overall phase was observed in 47% v. 21% of patients receiving the EMEND regimen compared to the control regimen, respectively (p<0.0001). Merck plans worldwide regulatory submissions for EMEND, beginning in the U.S. in the second half of 2014.

February 20, 2012

Soligenix issued preliminary results from a phase I/II trial of SGX201, a time-release formulation of oral beclomethasone dipropionate, for the prevention of acute radiation enteritis. This multicenter, open-label, sequential, dose-escalation study, dubbed BDP-ENT-01, enrolled 16 subjects with rectal cancer who were scheduled to undergo concurrent radiation and chemotherapy prior to surgery. The subjects received 1, 2, 3 or 4mg of SGX201 three times daily, with dosing administered throughout the duration of radiation therapy plus one week. Oral administration of SGX201 was safe and well tolerated across all four dose groups. There was also evidence of a potential dose response with respect to diarrhea, nausea and vomiting and the assessment of enteritis. The incidence of diarrhea was lower than that seen in historical control data.

December 1, 2006

Prostrakan reported positive results from a phase III trial of Sancuso for the treatment of emesis caused by chemotherapy, radiotherapy or anesthetics. This randomized, parallel group, double-blind, double-dummy study enrolled 641 subjects receiving moderately (ME) or highly emetogenic (HE) multi-day chemotherapy, across international sites. The patch was applied 24 to 48 hours before the first dose of chemotherapy, and kept in place for 7 days. Oral granisetron (2 mg) was administered daily for the duration of the chemotherapy regimen, one hour before each dose of chemotherapy. The primary endpoint was the proportion of subjetcs achieving no vomiting/retching, only mild nausea and no rescue medication from the first administration until 24 hours after the start of the last days administration of multi-day chemotherapy. Efficacy was established in 60.2% of subjects in the Sancuso arm and 64.8% of subjects receiving oral granisetron (difference -4.89%; 95% confidence interval -12.91% to +3.13%).

October 3, 2005

AP Pharma has reported positive results of a phase II trial of their investigational anti-emetic APF530, for the treatment and prevention of nausea and vomiting associated with chemotherapy. Safety data yielded no evidence of serious adverse events and a positive overall tolerability profile. Pharmacokinetic data established dose- proportional plasma levels, time to maximum concentration and overall expose, and supported use of a single subcutaneous dose of the drug 30 minutes prior to initiation of chemotherapy. Single subcutaneous doses provided sustained plasma exposure over time, of a duration suitable for treating both acute (day 1) and delayed (days 2-7) emetic symptoms. Efficacy data, measuring the number of emetic episodes, use of rescue medication, and the degree of daily patient-reported nausea, yielded positive results in both the acute: better than 90% of subjects in the lower 2 dosing groups and slightly less than 80% of subjects in the high dose group were acute-phase complete responders (no emetic episodes, no rescue medication), and in the delayed phase, complete response rates were better than 90%, better than 80%, and just under 70% for the low, middle and high dose groups, respectively. This open-label, dose-ascending study enrolled 45 chemotherapy patients, who received one of 3 single subcutaneous doses of the drug (5, 10 or 15 mg) prior to chemotherapy followed by a 7 day observational follow-up.

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