LAWRENCEVILLE, N.J., Aug. 24, 2017 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN), an oncology drug
development company, today provided an update on its OVATION Study, a Phase Ib dose escalating clinical trial combining GEN-1, the
Company's DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced (stage
III/IV) ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery. GEN-1 is an IL-12
DNA plasmid vector formulated as a nanoparticle in a non-viral delivery system to cause the sustained local production and
secretion of the Interleukin-12 (IL-12) protein loco-regionally to the tumor site.
The Company announced that an abstract for the OVATION Study has been accepted for presentation at the American
Association for Cancer Research (AACR) Addressing Critical Questions in Ovarian Cancer Research and Treatment Special Conference,
which will take place from October 1 – 4, 2017 at the Wyndham Grand Pittsburgh Downtown in Pittsburgh, PA.
- The abstract, entitled "Immunological changes following intraperitoneal administration of a formulated IL-12 plasmid in
combination with neoadjuvant chemotherapy in newly diagnosed advanced ovarian cancer patients," will be presented in a poster
presentation session by Dr. Khursheed Anwer, Celsion’s executive vice president and chief scientific officer.
- The presentation will summarize clinical findings and translational data from all patients treated in the Phase Ib dose
escalating clinical trial. The translational data provides further insight into GEN-1's mechanism of action through the
evaluation of dose-related changes in the tumor and peritoneal immune cell population, as well as through the peritoneal cytokine
levels.
Celsion previously reported highly encouraging clinical data from the first fourteen patients who have completed
treatment in the OVATION Study. GEN-1 plus standard chemotherapy produced positive clinical results, with no dose limiting
toxicities and promising dose dependent efficacy signals which correlate well with successful surgical outcomes as summarized
below:
- Of the fourteen patients treated to date in the entire study, two (2) patients demonstrated a complete response, ten (10)
patients demonstrated a partial response and two (2) patients demonstrated stable disease, as measured by RECIST criteria. This
translates to a 100% disease control rate ("DCR") and an 86% objective response rate ("ORR"). Of the five patients treated
in the highest dose cohort, there was a 100% objective response rate with one (1) complete response and four (4) partial
responses.
- Fourteen patients had successful resections of their tumors, with nine (9) patients (64%) having an R0 resection, which
indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor
bed. Seven out of eight (87%) patients in the highest two dose cohorts experienced a R0 surgical resection. All five
patients treated at the highest dose cohort experienced a R0 surgical resection.
- All patients experienced a clinically significant decrease in their CA-125 protein levels as of their most recent study
visit. CA-125 is used to monitor certain cancers during and after treatment. CA-125 is present in greater concentrations in
ovarian cancer cells than in other cells.
- Of the eight patients who have received GEN-1 treatment over one year ago and are being followed, only
two patients' cancer has progressed. This compares favorably to the historical median progression free survival (PFS)
of 12 months for newly-diagnosed patients with Stage III and IV ovarian cancer that undergo neoadjuvant chemotherapy followed by
interval debulking surgery. Of the remaining six patients who have been on the study for over one year, their average PFS
as of this date is 17 months with the longest progression-free patient at 23 months.
"We have completed enrollment of our OVATION Study in newly diagnosed ovarian cancer patients, one goal of which
is to determine GEN-1’s activity in combination with standard chemotherapy. The remarkable surgical outcomes among all
patients completing the prescribed eight weekly treatments reinforce our confidence in the promise of GEN-1’s ability to work
safely and effectively in advanced ovarian cancer," said Michael H. Tardugno, Celsion's chairman, president and CEO. “We have
scheduled an Advisory Board Meeting in late September 2017 with our clinical investigators and scientific experts from the Roswell
Park Cancer Institute and M.D. Anderson Cancer Center to review the clinical and translational research data from the OVATION Study
in order to determine the next steps forward for this exciting new immunotherapy. With the endorsement and recommendations
from the Advisory Board, we fully expect to file a next phase protocol with FDA later this year."
OVATION Study Design
The Phase Ib trial will evaluate weekly intraperitoneal dosing of GEN-1 in combination with neoadjuvant
chemotherapy, the standard of care for patients newly diagnosed with ovarian cancer. Concurrently with neoadjuvant chemotherapy,
enrolled patients will receive escalating weekly doses of GEN-1, from levels beginning at 36mg/m², to 47mg/m², 61mg/m² and 79mg/m²
weekly for 8 treatments in total, with interval debulking surgery to follow. The regimen will primarily be evaluated for its safety
and tolerability.
About GEN-1 Immunotherapy
GEN-1, designed using Celsion's proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector
encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12
protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of
T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase
I results with GEN-1 given as monotherapy in patients with peritoneally metastasized ovarian cancer, and recently completed a Phase
Ib trial of GEN-1 in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer.
About Celsion Corporation
Celsion is a fully-integrated oncology company focused on developing a portfolio of innovative cancer
treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. The Company's lead program is
ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the
treatment of primary liver cancer. The pipeline also includes GEN-1, a DNA-based immunotherapy for the localized treatment of
ovarian and brain cancers. Celsion has two platform technologies for the development of novel nucleic acid-based
immunotherapies and other anti-cancer DNA or RNA therapies. For more information on Celsion, visit our website: http://www.celsion.com. (CLSN-G1 CLSN-OV)
Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the
"safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such
forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of
research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical
data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the
significant expense, time, and risk of failure of conducting clinical trials; the need for Celsion to evaluate its future
development plans; possible acquisitions or licenses of other technologies, assets or businesses; possible actions by customers,
suppliers, competitors, regulatory authorities; and other risks detailed from time to time in Celsion's periodic reports and
prospectuses filed with the Securities and Exchange Commission. Celsion assumes no obligation to update or supplement
forward-looking statements that become untrue because of subsequent events, new information or otherwise.
Celsion Investor Contact Jeffrey W. Church Sr. Vice President and CFO 609-482-2455 jchurch@celsion.com
