A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company, today announced additional 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®) over a 5-day period. The Company presented the study results today at a poster presentation during the Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology (MASCC/ISOO) International Symposium in New York. As previously reported, 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).
“Delayed-onset nausea and vomiting remains a major issue associated with many cancer treatment options, which can affect a patient’s quality of life as well as his or her ability to sustain the recommended potentially lifesaving chemotherapy regimen,” said Rebecca A. Clark-Snow, RN, BSN, OCN, clinical nurse coordinator and chair of the MASCC Antiemetic Study Group. “In particular, patients who have experienced nausea and vomiting during previous chemotherapy treatments are more susceptible to experiencing a recurrence during subsequent therapy. These data indicate that APF530 has the potential to be a promising therapy option for physicians and patients.”
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.