HALIFAX, NOVA SCOTIA, Oct 26, 2011 (MARKETWIRE via COMTEX) -- Immunovaccine Inc. /quotes/zigman/570742 CA:IMV +16.67% today announced that Health Canada has cleared its Clinical Trial Application (CTA) for a phase I/II study with DPX-Survivac, a therapeutic cancer vaccine. The decision allows the Company to proceed with preparations in Canada to test the safety and efficacy of its immunotherapeutic vaccine in patients with advanced stage ovarian cancer.
The Canadian clinical trial application is part of the Company's strategy for a multi-centre phase I/II study for DPX-Survivac in patients with ovarian cancer. Immunovaccine has previously received approval from the FDA to proceed with a phase I/II study with DPX-Survivac in the U.S. The strong interest from Canadian oncologists in Immunovaccine's approach to treat ovarian cancer prompted the Company to pursue clearance of the same study protocol in Canada ahead of schedule.
"By combining a promising cancer target like survivin with our vaccine delivery platform, we hope to create an immunogenic vaccine that will provide a clinical benefit in patients with ovarian cancer," said Marc Mansour, Ph.D., Chief Science Officer and Chief Operating Officer at Immunovaccine.
The phase I/II study is designed to assess the safety, immunogenicity and clinical efficacy of the DPX-Survivac vaccine. Patients will be treated with the DPX-Survivac vaccine after completing debulking surgery and chemotherapy treatments.
An estimated 50,000 women in the U.S. and Canada will be diagnosed with ovarian cancer this year. As symptoms are vague and easily missed, it is one of the most deadly forms of cancer, with a five-year survival rate of only 37 percent.
The DPX-Survivac vaccine candidate uses antigens from survivin, a tumor-associated antigen that is present in cancer cells and has been associated with the progression of various cancers by independent studies. Survivin is an inhibitor of cell death and is therefore believed to be essential for the persistence of cancer in the body. It is hypothesized that cancer cells with continuous survivin expression will be a constant target for an anti-survivin immune response.
The DepoVax(TM) platform is a patented vaccine delivery and enhancement formulation that is expected to enhance the immunogenicity of the survivin antigen used in DPX-Survivac.
The National Cancer Institute (NCI) has classified survivin as a promising cancer antigen on the basis of its specificity to cancer cells and its presence in tumor specimens from a high proportion of cancer patients. Survivin is found in up to 90% of ovarian cancers. It is expected that DPX-Survivac will activate the body's immune cells to recognize and specifically kill cancer cells containing survivin.
The vaccine will be administered concurrently with an immune modulator to further enhance the activity of the vaccine. The phase I portion of the clinical trial design is an open label dose ranging study to identify the optimal dose of DPX-Survivac to use in the phase II portion of the study. After a successful phase I clinical trial, Immunovaccine will be permitted to initiate, without any further application to the FDA or Health Canada, a randomized double-blinded placebo-controlled phase II clinical trial to assess the clinical benefit of DPX-Survivac in patients with advanced ovarian cancer.
For more information about this and other clinical trials in ovarian cancer, please visit www.clinicaltrials.gov .
Immunovaccine Inc. develops vaccines formulated in its vaccine delivery platform for cancer therapy and infectious disease. The Company's DepoVax(TM) platform is a patented lipid delivery system that presents antigens plus adjuvant to the immune system for a prolonged period and has the potential to enhance immune responses. Immunovaccine has taken its platform technology and proprietary cancer vaccine into phase I human trials and has demonstrated its safety and immunogenicity potential. The Company is also capitalizing on the broad potential of its delivery platform by creating new DepoVax-based vaccines through multiple development collaborations. In addition to the Company's human health vaccine strategy, it continues to capture value from animal health vaccine applications. Pfizer Animal Health has licensed the Company's delivery technology platform to develop vaccines for livestock. Connect at www.imvaccine.com or www.twitter.com/immunovaccine .
This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Company, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals. Immunovaccine Inc. assumes no responsibility to update forward-looking statements in this press release.
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