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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

articipants will initially receive six doses of two DNA vaccines (called p.DOM-WT1-37 and p.DOM-WT1-126) delivered at four week intervals. Vaccine responders may continue with booster vaccinations every three months out to 24 months. An additional 100-110 AML/CML patients will be enrolled across the two arms as non-vaccinated controls for comparison. The primary endpoints will be molecular response to a disease marker called BCR-ABL in CML patients and time to disease progression in AML patients. The study will also monitor WT1 transcript levels, immune responses to the WT1 antigen, time to progression and overall survival, and two-year survival in the AML group. The trial will take place at hospitals in Southampton, London and Exeter over the next two years. Regulatory approval to start this clinical study was provided by the UK Medicines and Healthcare Products Regulatory Authority (MHRA) and Gene Technology Advisory Committee (GTAC).

This is the first clinical trial using Inovio's new ELGEN-1000 automated device, which is based on its proprietary electroporation delivery platform. The device's needle electrodes automate vaccine delivery at the push of a button and co-locate subsequent controlled, millisecond electrical pulses that increase cell membrane permeability and dramatically improve cellular uptake of the vaccine. Inovio's electroporation systems have been shown to increase levels of gene expression (production of the antigen coded by the DNA vaccine) up to 1000-fold and increase immune responses to the antigen up to 100-fold.

Inovio's CEO, Dr. J. Joseph Kim, said, "This leukemia study expands Inovio's long-standing relationship with the University of Southampton into an important disease area and moves our first fully automated injection-electroporation delivery product into human studies. This program could further validate the ability of Inovio's DNA vaccines and delivery platform to generate clinically relevant immune responses and effe
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SOURCE Inovio Pharmaceuticals, Inc.
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