Jan 26 2016
AVAX Technologies, Inc. (USOTC: AVXT), a pioneer in personalized cancer vaccines, today announced the results of its Phase 1/2 OVAX study in patients with platinum resistant relapsed Stage III or IV Ovarian Cancer. The overall design is a Phase I/II, double-blind, three-dose regimen, multi-centered, trial in patients with stage III or stage IV ovarian carcinoma who have undergone de-bulking followed by intra-peritoneal chemotherapy.
Study Endpoints were treatment-emergent and related adverse events, serious adverse events, and grade 3 and 4 laboratory abnormalities for safety assessment, DTH responses to DNP-modified and unmodified autologous ovarian cancer cells. Other measured parameters were CA-125 levels and survival.
A total of 34 patients were enrolled in the study out of which 2 were lost to follow-up. 34 patients were treated at 3 doses. 12/34 are alive with 8 more than 3 years and median survival is 22.7 months. No treatment-related Serious Adverse Events have been observed.
AVAX's management continues to be very encouraged and optimistic about the prospects of its personalized autologous cancer vaccine platform. "This study indicates that OVAX can be safely administered to patients with advanced ovarian cancer," commented Dr. David Berd, Chief Medical Officer of AVAX Technologies. "We are also encouraged by the survival results, which appear promising in this group of very advanced ovarian cancer patients whose tumors were resistant to standard chemotherapy."
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