Celsion Announces Publication Highlighting the Potential of Celsion's Gene-Mediated Immunotherapy to Improve Administration of IL-12 and Progression-Free Survival in Ovarian Cancer Patients
Analysis in peer-reviewed journal, Future Oncology, outlines the ability of GEN-1, a non-viral nanoparticle delivery system, to support persistent local production of IL-12
“Ovarian cancer is a disease of high unmet need, with only marginal improvements in treatment outcomes over the last two decades,” said Dr. Thaker. “It is characterized by a strong immunosuppressive environment and spontaneous anti-tumor reactive T-cells and antibodies. Celsion’s GEN-1 is a novel immunotherapy agent delivered intraperitoneally and engineered to provide a steady dose of IL-12 immunotherapy to women with ovarian cancer in a localized and durable manner. Importantly, GEN-1 has the potential to reduce the risk of toxicities associated with use of recombinant IL-12 protein that has severely limited this therapy as a treatment option.”
“Clinical experience with GEN-1 in women with recurrent ovarian cancer shows treatment feasibility with good safety,” Dr. Thaker continued. “Currently median progression free survival in treatment of newly diagnosed ovarian cancer following neoadjuvant chemotherapy treatment is 12 months. If GEN-1 is able to support significant improvements in PFS in this patient population, this could represent a major advancement in care in the years ahead”
Full Article Available on Celsion’s Website
To view the complete article in Future Oncology, please visit Celsion’s corporate website at http://investor.celsion.com/scientific-presentations.
About OVATION I Study
The Phase IB OVATION I Study evaluated escalating doses of GEN-1 in combination with neoadjuvant chemotherapy in the treatment of newly diagnosed patients with Stage III/IV ovarian cancer. Concurrently with neoadjuvant chemotherapy, enrolled patients received escalating weekly doses of GEN-1, from levels beginning at 36mg/m², to 47mg/m², 61mg/m² and 79mg/m² weekly for eight treatments in total, followed by interval debulking surgery. A total of 18 patients were enrolled to one of four dosing cohorts described above. Three patients dropped out of the study after 13 days or less receiving only one of eight GEN-1 doses, and two patients did not receive complete GEN-1 plus neoadjuvant chemotherapy treatment.
About OVATION 2 Study
OVATION 2 is a Phase I/II study designed with a single dose-escalation phase to 100 mg/m² of GEN-1 administered intraperitoneally in the Phase I portion, followed by a continuation at the selected dose in Phase II, in an open-label, 1:1 randomized design. In OVATION 2, patients in the GEN-1 treatment arm will receive GEN-1 plus chemotherapy prior to debulking surgery, with continued GEN-1 and chemotherapy dosing following surgery. OVATION 2 will include up to 130 patients with Stage III/IV ovarian cancer, with approximately 12 patients in the Phase I portion and 118 patients in Phase II. The study is powered to show a 33% improvement in the primary endpoint, progression-free survival (PFS), when comparing GEN-1 with chemotherapy versus chemotherapy alone. The PFS primary analysis will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later. Under the open-label design, clinical data will be disclosed throughout the execution of the trial as it is released by the study's investigators. Data from the dose-escalating portion of OVATION 2 are expected in the first half of 2019.
About GEN-1 Immunotherapy
GEN-1, designed using
About Celsion Corporation
Marianne Lambertson VP Communications & Investor Relations609-482-2498 firstname.lastname@example.org Argot Partners Sam Martin212-600-1902 Sam@argotpartners.com
Source: Celsion CORP