HALIFAX, NOVA SCOTIA -- (Marketwired) -- 06/03/13 -- Immunovaccine Inc. ("Immunovaccine" or the "Company") (TSX VENTURE: IMV), a clinical stage vaccine company, presented positive results from a Phase I clinical study of DPX-Survivac, one of the Company's two clinical stage cancer vaccines, this weekend at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting. In a poster presentation at the conference, Immunovaccine highlighted study results that showed ovarian cancer patients treated with DPX-Survivac combined with low dose oral cyclophosphamide experienced pronounced and persistent T cell immune responses against survivin, a protein strongly associated with several tumor types. The company believes that these immune responses are consistent in profile to those necessary from a cancer vaccine to potentially impact disease progression. These study results were further discussed by Dr. Jedd Wolchok of Memorial Sloan-Kettering Cancer Center, a top thought leader in the area of cancer immunotherapy, at the poster discussion session that followed.
The Phase I study evaluated DPX-Survivac in combination with a maintenance low dose oral cyclophosphamide in ovarian cancer patients who have responded favorably to a standard of care platinum-based chemotherapy. The dose of cyclophosphamide was designed to have an immune modulation rather than a chemotherapeutic effect. Patients were enrolled in a non-randomized dose escalation fashion to receive three doses of DPX-Survivac alone or the vaccine along with cyclophosphamide. Patients receiving the combination treatment received one of two vaccine doses to evaluate a dose response to the vaccine.
A detailed study analysis showed that patients receiving the highest dose of DPX-Survivac demonstrated significantly higher survivin specific immune responses that were produced following one or two vaccinations and sustained after the third vaccination for at least three months. The durable systemic T cell response consisted of central and effector memory CD8 positive T cells that were of sufficient magnitude to be detected in peripheral blood without additional in vitro amplification. Persistent circulating memory CD4 positive and late differentiated CD8 positive T cells were also detected. Results were confirmed using multiple immune monitoring assays, including ELISpot, tetramer analysis and multiparametric immune cell staining.
The combination of DPX-Survivac and oral cyclophosphamide was generally well tolerated with no significant systemic adverse events. The most commonly reported adverse events were injection site reactions which were most prominent after repeated immunizations in patients receiving the highest dose of DPX-Survivac with cyclophosphamide. It is important to note that these patients receiving the highest DPX-Survivac dose also presented the strongest immune responses during the study.
"The high magnitude of persistent T cell immunity against survivin achieved in this study validates our concept of combining DPX-Survivac with oral cyclophosphamide," said Marc Mansour, chief science officer of Immunovaccine, who presented the data during the ASCO poster session. "Just as importantly, these T cells have the activation profile that therapeutic vaccines must achieve to potentially influence disease progression. As a result, we have a solid foundation to move our vaccine strategy forward into a randomized Phase II study."
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