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FDA Approves Immunovaccine's Application for a Phase I/II Clinical Trial for an Ovarian Cancer Vaccine

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Immunovaccine Inc., has announced that the US Food and Drug Administration (FDA) reviewed and cleared its Investigational New Drug (IND) application for a Phase I/II clinical study with DPX-Survivac, a therapeutic cancer vaccine. DPX-Survivac will be tested in patients with ovarian cancer.

The DPX-Survivac vaccine candidate uses antigens from survivin (in-licensed from Merck KGaA) which are formulated in the DepoVax™ vaccine delivery platform. Survivin is a tumor-associated antigen that is present in cancer cells and generally not expressed in normal cells.

Survivin is required by cancer cells to survive, making it a particularly interesting target to test in a cancer vaccine. The DepoVax platform is a patented vaccine delivery formulation that is expected to enhance an immune response targeting cancer cells that contain survivin.

"With few options available for treating advanced stage ovarian cancer, we are very pleased to get the green light from the FDA to begin this innovative clinical trial," said Dr. Marc Mansour, Chief Operating Officer and Chief Science Officer.

Dr. Mansour continued, "We have optimized the survivin antigens in our DepoVax formulation, and we have designed a trial that incorporates new concepts and recent advances made in the field of immunotherapy."

The Phase I/II multicentre clinical trial 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.

The vaccine will be administered to patients who will also receive an immune modulating drug to enhance the effect of the vaccine on cancer cells.

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. Immunovaccine expects to start the Phase I study in Q4 of 2011.

After a successful Phase I clinical trial, Immunovaccine will be permitted to initiate, without any further application to the FDA, a randomized double-blinded placebo-controlled Phase II clinical trial to assess the clinical benefit of DPX-Survivac in patients with advanced ovarian cancer.

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.

Ovarian cancer has the highest mortality of all cancers of the female reproductive system. This reflects, in part, a lack of early symptoms and ovarian cancer screening tests.

Ovarian cancer is often diagnosed at an advanced stage, after the cancer has spread beyond the ovary. It is estimated that approximately $2.2 billion is spent in the United States each year on treatment of ovarian cancer.