Phase I/II Clinical Plan for DPX-Survivac to Target Ovarian Cancer Announced
News Nov 26, 2010
The development plan was based on positive input from key opinion leaders in cancer immunotherapy. The Company has also successfully manufactured test batches of DPX-Survivac and established the analytical methods to support the release of a future clinical trial batch.
"We look forward to advancing the clinical development of DPX-Survivac as a potential treatment for ovarian cancer," said Dr. Randal Chase, President and CEO of Immunovaccine. "This is a silent disease for which so many women are diagnosed once the cancer is in an advanced stage and treatment options are limited."
About the Development Plan for DPX-Survivac
Initial immunogenicity studies in a mouse model showed that Survivac peptides, formulated in DepoVax™, produced more antigen-specific, interferon gamma-producing immune cells, compared to a control formulation previously used in clinical trials. Preliminary safety assessments also indicated that the vaccine administered to mice was well tolerated.
The clinical development plan includes completing more detailed safety and immunogenicity data over the next few months to support a potential future investigational new drug (IND) regulatory filing with the FDA. The clinical plan foresees a seamless transition from the Phase I into the Phase II.
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