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University of Southampton and Inovio Pharmaceuticals Initiate Phase 2 Clinical Study to Evaluate Leukemia DNA Vaccine Using Electroporation Delivery Technology
Date:1/31/2011

h electroporation delivery of WT1 antigens with the goal of stimulating high and durable levels of immune responses, critical for improving clinical outcomes.

The principal investigator of this study, Dr. Christian H. Ottensmeier, MD, PhD, Professor of Experimental Cancer Research at the University of Southampton, said, "Wilms' Tumor gene 1 has emerged as one of the most promising targets for immunotherapy of blood malignancies including chronic myeloid leukemia (CML) and acute myeloid leukemia (AML). We previously reported strong immune responses in our prostate cancer vaccine trial using a similar DNA-electroporation approach. In that trial, patients with relapsed prostate cancer showed vaccine-induced immune responses that persisted to the end of the trial follow-up at 18 months. We are excited to extend this promising vaccine approach to CML and AML, for which better treatment options are sorely needed. This trial will evaluate the WT1 DNA vaccine in two parallel settings with the purpose of identifying the most promising path forward for a pivotal Phase 3 clinical trial."

Dr. David Grant, Scientific Director of Leukaemia and Lymphoma Research said: "It is an important step for us to see the laboratory work on DNA vaccines that LLR has supported take the next logical step into clinical testing. The trial has undergone extensive international peer review and we are delighted to see this trial in leukemia go ahead. We believe that this vaccine has real promise to improve outcomes in patients with leukemia."

The single dose level, Phase 2 study, called "WT1 immunity via DNA fusion gene vaccination in haematological malignancies by intramuscular injection followed by intramuscular electroporation," led by Professor Ottensmeier and Dr. Katy Rezvani of Imperial College London and Hammersmith Hospital, London, is designed to recruit two patient groups. One group is planned to recruit up to 37 CML patients and the other up to 37 AML patients. All p
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SOURCE Inovio Pharmaceuticals, Inc.
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