Celsion Announces FDA Clearance of the OVATION II Study for the Evaluation of GEN-1 Immunotherapy to Treat Newly Diagnosed Stage III/IV Ovarian Cancer
GEN-1 to Enter the Clinic in Mid-2018 Following a Phase IB Trial Which Demonstrated 100% Disease Control, 86% Objective Response Rate and 86% R0 & R1 Surgical Resection Rate in All Patients Treated
Compelling Progression-Free Survival Data from
This next Phase I/II study is designed with a single dose escalation phase to 100 mg/m² to identify a safe and tolerable dose of GEN-1 while maximizing an immune response, followed by a continuation at the selected dose in Phase II in an open label, 1:1 randomized design up to 90 patients with Stage III/IV ovarian cancer at up to fifteen
Progression-free survival for patients treated per protocol in the Phase IB OVATION Study continues to be followed. Of the thirteen patients who received GEN-1 treatment in all four dose escalating cohorts, only four patients' cancer has progressed to-date. This compares favorably to the historical median progression-free survival of 12 months for newly-diagnosed patients with Stage III and IV ovarian cancer that undergo neoadjuvant chemotherapy followed by interval debulking surgery. Summarized below are the latest PFS results for all patients treated per protocol in the Phase IB OVATION Study:
- Cohort 1 (36 mg/m²) - All patients have progressed; Average PFS was 19.25 months; Longest progression-free patient in 1st cohort was 24.8 months.
- Cohort 2 (47 mg/m²) - No patients have progressed after 21 months.
- Cohort 3 (61 mg/m²) - One patient has progressed after 14 months; Two other patients in 3rd cohort are progression free over 17 months.
- Cohort 4 (79 mg/m²) - No patients have progressed; Average PFS for these five patients in 4th cohort is 14 months.
"In previous clinical studies performed to date, GEN-1 has demonstrated excellent safety and impressive clinical activity supported with dose dependent, pro-immune improvement in the tumor micro environment. A onetime dose escalation may prove to be even more impressive," stated Dr.
The Company expects to initiate enrollment of the Phase I portion of the OVATION II Study in the first half of 2018. The Company expects to have 25% of the study enrolled by the end of 2018. Due to the open label design, clinical data will be disclosed throughout the execution of the trial as it is released by the study's investigators.
"GEN-1 holds the potential for tremendous promise as a cancer treatment in the rapidly emerging area of immunotherapy. This new trial will evaluate GEN-1's value as an adjuvant to current standard of care in newly diagnosed Stage III/IV ovarian cancer patients with a relatively healthy immune system. We look forward to initiating the study in the first half of 2018," said
About GEN-1 Immunotherapy
GEN-1, designed using
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Celsion Investor Contact
Jeffrey W. ChurchSr. Vice President and CFO 609-482-2455 email@example.com
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