The trial enrolled a total of 110 subjects with recently diagnosed Stage III/IV ovarian cancer. Credit: Nephron / commons.wikimedia.org.

Celsion has concluded subject enrolment in the Phase I/II OVATION 2 Study of its IL-12 gene-mediated immunotherapy, GEN-1, in advanced ovarian cancer patients. 

The trial enrolled a total of 110 subjects with recently diagnosed Stage III/IV ovarian cancer.

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Subjects in the trial will receive GEN-1, along with standard-of-care neoadjuvant chemotherapy (NACT). 

NACT is created for minimising the tumour size for optimal removal in a surgical procedure following three chemotherapy cycles. 

Patients who receive NACT subsequently undergo interval debulking surgery. This is followed by three more cycles of chemotherapy for treating any remaining tumour.

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The trial will analyse GEN-1 plus NACT in the treatment arm compared to NACT alone in the control arm.

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Designed with an 80% confidence interval, the trial should indicate a nearly 33% improvement in progression-free survival on comparing the treatment arm to the control arm.

The company anticipates topline data from the trial in the second half of next year.

According to the interim trial findings in June this year from 70 subjects, who underwent interval debulking surgery, those in the GEN-1 treatment arm had improvement in complete tumour resection (R0) surgical resection rates versus the control arm.

Subjects in the treatment arm also had complete/near complete (CRS 3) chemotherapy response scores, compared to the control arm.

GEN-1 is created using the TheraPlas platform technology of the company.

Celsion president and CEO Corinne Le Goff said: “We are delighted to reach this important milestone of completing enrolment in our Phase I/II OVATION 2 Study with GEN-1 and are optimistic the study will show our technology’s ability to deliver the powerful immune-modulating agent IL-12. 

“Preliminary interim data in this study are very promising, showing both safety and activity.”