For its cervical cancer vaccine, Inovio is currently conducting a randomized, placebo controlled, double blind Phase II study evaluating the effects of VGX-3100 treatment on the clearance of moderate or severe cervical intraepithelial neoplasia (CIN 2/3) cervical lesions. A total of 148 patients will be enrolled in 25 study centers in the US, Korea, South Africa, Australia, and Canada.
In a previous Phase I study of 18 adult females with CIN 2/3 stages, 72% of vaccinated subjects (13 of 18) developed significant antigen-specific T-cell responses during the first four months of treatment (each patient was vaccinated at months 0, 1, and 3) by standardized T cell assay. Furthermore, 91% of evaluable responders (10 of 11) displayed strong and persistent memory T-cell responses at month 9, with strong T cell responses.
In the Phase I escalating dose study, all three dose groups experienced significant antigen specific antibody and T-cell immune responses against multiple antigens. In the third and final dose group, five of six (83%) patients developed the highest level of T-cell responses achieved by any non-replicating vaccine platform in patients to date.
The leukemia study, pWT1, utilizing Inovio's electroporation delivery technology, is a single dose, Phase II trial currently recruiting up to 170 CML and AML patients. This leukemia trial is being conducted in a collaboration with the University of Southampton. All vaccinated subjects 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. The study will also have control AML/CML patients 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
|SOURCE Inovio Pharmaceuticals, Inc.|
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