Immunovaccine Vaccinates First Patient in Phase I Trial of the DPX-Survivac Cancer Vaccine
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The DPX-Survivac Phase I and II clinical trials have been cleared by both the U.S. FDA and Health Canada. DPX-Survivac is a survivin-targeting vaccine formulated in the DepoVax™ platform, a patented vaccine delivery and method that is expected to enhance the immunogenicity of the survivin antigen used in DPX-Survivac. The survivin antigen contained in the vaccine is a broadly expressed, tumor-associated antigen shown to sustain the survival of cancer cells. In combination with the DepoVax platform, it is expected to stimulate the immune system to destroy cancer cells expressing survivin and delay cancer recurrence.
DPX-Survivac will be administered to patients after debulking surgery and chemotherapy treatments. Vaccinated patients will also receive an immune modulating drug to further enhance the activity of the vaccine.
“We believe this is the right vaccine being administered at the right time,” commented Dr. Mansour, Chief Science and Operating Officer. “Applying our DepoVax enhanced vaccine after surgery and chemotherapy is when therapeutic cancer vaccines are expected to be most effective.”
About the Clinical Trial
The Phase I portion of the DPX-Survivac clinical trial is an open-label, dose-ranging study, enrolling up to 15 patients with stage IIc-IV ovarian cancer. Preliminary safety results, established from the first three patients, are expected in Q1/Q2 2012. Completion of patient enrollment in the Phase I study, along with a broader assessment of the vaccine’s safety and immune activity is estimated to be completed by Q4 2012.
Following the completion of the Phase I clinical trial, Immunovaccine is cleared to initiate, without any further application to the U.S. FDA or Health Canada, a randomized, double-blinded, placebo-controlled Phase II clinical trial, with a selected vaccine dose. The Phase II trial will assess the clinical benefit of DPX-Survivac in patients with advanced ovarian cancer. For more details visit www.clinicaltrials.gov.
