LAWRENCEVILLE, N.J.,
Sept. 30, 2015 /PRNewswire/
-- Celsion Corporation (Celsion) (NASDAQ:CLSN), a
fully-integrated oncology company focused on the development of a
portfolio of innovative cancer treatments, including directed
chemotherapies, immunotherapies and RNA- or DNA-based therapies for
the treatment of cancer and other difficult-to-treat diseases,
today announced the enrollment of the first patient 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 ovarian cancer patients
who will undergo neoadjuvant chemotherapy. The first patient
in the OVATION Study was enrolled at the University of Alabama at Birmingham (UAB). In
addition to UAB, Oklahoma University
Medical Center is now also recruiting patients in the OVATION
Study. Celsion plans to initiate two additional sites in the
coming months. Interim findings from this open label study are
expected in the fourth quarter of 2015. The study will
continue into the first half of next year at higher doses of
GEN-1.
The OVATION Study will seek to identify a safe, tolerable and
therapeutically active dose of GEN-1 by recruiting and maximizing
an immune response. The trial is designed to enroll three to
six patients per dose level and will evaluate safety and efficacy
and attempt to define an optimal dose for a follow-on Phase I/II
study combining GEN-1 with Avastin® and Doxil®. In
addition, the OVATION Study establishes a unique opportunity to
assess how cytokine-based compounds such as GEN-1, directly affects
ovarian cancer cells and the tumor microenvironment in newly
diagnosed patients. The study is designed to characterize the
nature of the immune response triggered by GEN-1 at various levels
of the patients' immune system, including:
- infiltration of cancer fighting T-cell lymphocytes into primary
tumor and tumor microenvironment including peritoneal cavity, which
is the primary site of metastasis of ovarian cancer;
- changes in local and systemic levels of immuno-stimulatory and
immunosuppressive cytokines associated with tumor suppression and
growth, respectively; and
- expression profile of a comprehensive panel of immune related
genes in pre-treatment and GEN-1-treated tumor tissue.
These extensive mechanistic studies will assist in the design of
novel combination approaches with immunotherapies and other
anti-cancer agents driven by potential synergistic action
mechanisms, and define an enhanced patient population based on
molecular characteristics inherent to tumor tissue or the immune
system.
GEN-1 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. GEN-1 has
demonstrated encouraging safety and efficacy data in a Phase Ib
trial in combination with PEGylated doxorubicin in patients with
platinum-resistant ovarian cancer. The findings from this trial
demonstrated an overall clinical benefit of 57% for all treatment
arms, with a partial response (PR) rate of 21% and a stable disease
(SD) rate of 36%. The overall clinical benefit observed at the
highest dose cohort in this difficult-to-treat patient population
was 100% (PR=33% and SD=67%) in all six evaluable patients. GEN-1
was well tolerated, with no dose limiting toxicities and no
overlapping toxicities between GEN-1 and pegylated
doxorubicin.
"Developing more effective immunotherapy approaches for ovarian
cancer is a high priority for those of us who care for the
thousands of patients affected by advanced ovarian cancer.
GEN-1 is a novel IL-12 expressing lipopolymer that has
demonstrated promising activity in preclinical and early phase
clinical trials in ovarian cancer," stated Premal H. Thaker, M.D., associate professor,
Division of Gynecologic Oncology, Department of Obstetrics and
Gynecology, Washington University
School of Medicine. "In preclinical and clinical studies
performed to date, GEN-1 has demonstrated good safety and
impressive immune system stimulation and activity, and this trial
will evaluate its value as an adjuvant to chemotherapy in patients
with a relatively healthy immune system."
"GEN-1 is designed to locally activate IL-12 production, which
can stimulate the patient's immune system to attack and destroy
cancer," stated Dr. Nicolas Borys,
Celsion's senior vice president and chief medical officer.
"Increases in IL-12 concentrations at the tumor site could create a
potent immune environment against tumor activity resulting in a
more robust and durable antitumor response compared to chemotherapy
alone. We are conducting this trial in newly diagnosed
patients with good immune systems in order to maximize the success
of GEN-1's novel mechanism."
"GEN-1 holds tremendous promise as a potential treatment in the
rapidly emerging area of immuno-oncology. Unlike the toxicities,
poor tolerability, and poor pharmacokinetics of systemically
administered recombinant IL-12, the beauty of GEN-1 is that it
inspires secretion of highly-tolerable endogenous IL-12," said
Michael H. Tardugno, Celsion's
chairman, president and chief executive officer. "Designed in
consultation with clinicians, this Phase I trial is expected to
define an optimal dose and potentially an enhanced
population. It will also provide insights on powering for a
registration program as the candidate progresses through
development."
About GEN-1 Immunotherapy
GEN-1, designed using the 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 in combination with PEGylated doxorubicin in
patients with platinum resistant ovarian cancer. GEN-1 has
also demonstrated preclinical activity in glioblastoma multiforme
(brain cancer) and the Company plans to initiate a Phase I study in
this indication.
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
anti-cancer DNA or RNA therapies, including TheraPlas™ and
TheraSilence™. For more information on Celsion, visit our
website: http://www.celsion.com.
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 the 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
Celsion Media Contacts
Harriet Shelare
Director, Communications
860-483-1721
hshelare@celsion.com
Bill Berry
Berry & Company
212-253-8881
bberry@berrypr.com
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SOURCE Celsion Corporation