Phase 3 Study Update of APF530 for Chemotherapy-Induced Nausea and Vomiting

A.P. Pharma announced data from the Company's Phase 3 study of APF530 for the prevention of chemotherapy-induced nausea and vomiting (CINV). The findings from the analysis of this subset of data indicate that APF530 offered comparable nausea control and patient satisfaction to palonosetron (Aloxi; Eisai) over a 5-day period. The Phase 3 study showed APF530 was comparable to palonosetron in preventing both acute- and delayed-onset CINV in patients receiving either moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC).

The pivotal Phase 3 clinical trial was a multicenter, randomized, observer-blind, actively-controlled, double-dummy, parallel group study that compared the efficacy of APF530 with palonosetron. The trial stratified patients into two groups, one receiving moderately and the other receiving highly emetogenic chemotherapeutic agents in accordance with the Hesketh algorithm, which assigns emetogenic levels based on the chemotherapy agent, drug dosage and combinations employed. In each group, the patients were randomized to receive in the first chemotherapy treatment cycle either APF530 high dose (10mg granisetron), APF530 low dose (5mg granisetron) or the currently approved dose of palonosetron. Patients used a daily diary to record severity of nausea, vomiting/retching episodes, use of rescue medication, and satisfaction with nausea/vomiting control over a 5-day period following chemotherapy.

The study found patient satisfaction between patients administered APF530 and palonosetron to prevent CINV following MEC or HEC were comparable, with no statistically significant differences. The severity of nausea experienced by patients in the study was also comparable with no statistically significant differences. These findings held for subgroups of patients regardless of whether, or not, they had previously received chemotherapy treatment. The study also showed that for each day of a 5-day period there were no statistically significant differences between APF530 and palonosetron in patient satisfaction and severity of nausea.

APF530 is in development for the prevention of both acute-onset and delayed-onset chemotherapy-induced nausea and vomiting (CINV). APF530 contains the 5-HT3 antagonist, granisetron, formulated in the Company's proprietary Biochronomer drug delivery system, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection.

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