Celsion Announces Positive Data from the OVATION Study - An Immunotherapy Study of Newly Diagnosed Ovarian Cancer Patients
July 25 2016 - 8:00AM
Celsion Corporation (NASDAQ:CLSN) today announced data from
the second cohort of patients in its Phase Ib dose escalating
clinical trial (the OVATION Study) combining GEN-1, the Company's
DNA-based immunotherapy, with the standard of care for the
treatment of newly-diagnosed patients with advanced ovarian cancer
who will undergo neoadjuvant chemotherapy followed by interval
debulking surgery. In the first six patients dosed, GEN-1 plus
standard chemotherapy produced impressive results, with no dose
limiting toxicities and highly promising efficacy signals in this
difficult to treat cancer.
“The totality of study data available to date
suggests that GEN-1 holds great potential to serve as an effective,
safe IL-12 immunotherapy in ovarian cancer,” said Dr. Premal
Thaker, Associate Professor in Gynecologic Oncology, Washington
University School of Medicine and OVATION Study Investigator.
“Notably, we have seen dramatic decreases of 95% or greater in
CA-125 protein levels, which serve as a key indicator of the
presence of ovarian cancer cells, as well as impressive
pathological response data, which is associated with prolonged
survival. We look forward to the completion of this study, and to
learning more about how GEN-1 performs in this patient
population.”
The OVATION Study is designed to enroll three to
six patients per dose cohort, and will continue into 2016 at higher
doses of GEN-1 with the goal to identify a safe, tolerable and
therapeutically active dose of GEN-1 by recruiting and maximizing
an immune response. The first two cohorts each enrolled three
patients. Enrollment in the third cohort is ongoing, and
Celsion expects to complete the OVATION Study this year. Future
studies of GEN-1 will include a Phase I/II study combining GEN-1
with Avastin® and Doxil®.
OVATION Study – Results to
Date
- Of the first six patients dosed, one patient demonstrated a
complete response (CR), two patients demonstrated partial response
(PR) and three patients demonstrated stable disease (SD), as
measured by RECIST criteria.
- Five patients had successful resections of their tumors, with
two patients having an R0 resection, which indicates a
microscopically margin-negative resection in which no gross or
microscopic tumor remains in the tumor bed and three patients with
a R1 resection, indicating microscopic residual tumor. One patient
in the second cohort is currently ineligible for debulking surgery
due to a medical complication unrelated to the study or the study
drug.
- Of the five surgically treated and evaluable patients, one
patient demonstrated a pathological complete response (pCR), two
patients (40%) demonstrated a micro pathological response
(microPR), and two patients (40%) demonstrated a macroPR. These
data compare favorably to historical data, which indicate that pCRs
are typically seen in less than 7% of patients receiving
neoadjuvant chemotherapy followed by surgical resection. pCRs have
been associated with a median overall survival of 72 months, which
is more than three years longer than those who do not experience a
pCR. In addition, microPRs are seen in approximately 30% of
patients, and are associated with a median overall survival of 38
months¹.
“GEN-1 continues to demonstrate impressive
activity in patients with advanced Stage III and IV ovarian cancer,
a population clearly in need of effective therapies,” said Nicholas
Borys, M.D., Celsion's chief medical officer. “We anticipate
completion of enrollment in the third patient cohort in the coming
weeks, and will continue to assess a potential accelerated clinical
development path for GEN-1. In parallel, we are currently
evaluating translational data from the study, which we expect to
report before the end of the third quarter.”
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 and in Phase II development for the treatment of
recurrent chest wall breast 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 anticancer DNA or RNA therapies, including TheraPlas™ and
TheraSilence™. 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.
¹ Petrillo M, Zannoni GF, Tortorella L, et
al. Prognostic role and predictors of complete pathologic response
to neoadjuvant chemotherapy in primary unresectable ovarian cancer.
American Journal of Obstetrics & Gynecology 2014
Celsion Investor Contact
Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
jchurch@celsion.com
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