Inovio reports positive preliminary data from Phase II leukaemia trial

9th December 2012 (Last Updated December 9th, 2012 18:30)

Inovio Pharmaceuticals has reported positive interim results from a Phase II leukaemia trial of its WT1 DNA vaccine.

Inovio Pharmaceuticals has reported positive interim results from a Phase II leukaemia trial of its WT1 DNA vaccine.

The WT1 DNA vaccine, delivered with Inovio's electroporation delivery system, demonstrated vaccine-specific antibody responses including T cell immune responses in all vaccinated subjects.

Inovio CEO Dr Joseph Kim said the preliminary Phase II data demonstrated the vaccine's potential to produce T cells and antibodies to treat leukaemia.

"These results follow on our recent scientific breakthrough represented by our human data showing the powerful killing effect of T cells generated by our cervical dysplasia therapeutic vaccine," Kim said.

"The WT1 DNA vaccine, delivered with Inovio's electroporation delivery system, demonstrated vaccine-specific antibody responses including T cell immune responses in all vaccinated subjects."

According to the preliminary data, the vaccine, which was developed by the University of Southampton, demonstrated a good safety profile and was well-tolerated by the subjects.

The Phase II trial will enrol 31 patients in its chronic myelogenous leukaemia (CML) arm.

So far, 14 CML patients have been enrolled, while another 13 unvaccinated CML patients were enrolled to serve as a control group.

The trial will enrol the acute myeloid leukaemia (AML) clinical trial arm, with a total target of 37 subjects in each of the vaccinated and control groups.

Open-label, multi-centre Phase II trial is evaluating a DNA vaccine-based immune therapy with molecular responses to BCR-ABL in CML patients and time to disease progression in AML patients are the primary endpoints.

WT1 transcript levels, immune responses to the WT1 antigen, time to progression,overall survival and two-year survival in the AML group will also be monitored in the study.