LAWRENCEVILLE, N.J.,
Feb. 12, 2016 /PRNewswire/ -- Celsion
Corporation (Celsion) (NASDAQ: CLSN), a fully-integrated oncology
company focused on the development of a portfolio of innovative
cancer treatments, today highlighted recent accomplishments related
to the Company's GEN-1 immunotherapy pipeline and provided a
general business update. Celsion also announced the
completion of enrollment of the first cohort of patients in its
Phase 1b 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 followed
by surgical resection of their tumor.
"GEN-1 is designed to locally activate IL-12 production using
our novel targeted non-viral delivery platform for a sustained
period for up to 7 days in the tumor environment," stated Dr.
Nicolas Borys, Celsion's senior vice
president and chief medical officer. "Emerging preclinical
and translational data demonstrate that GEN-1 stimulates the local
cellular production and secretion of highly-tolerable endogenous
IL-12, a potent multi-mechanistic anti-cancer agent, while limiting
toxicities, poor tolerability, and poor pharmacokinetics associated
with systemically administered recombinant IL-12."
The OVATION Study
The first two patients in the OVATION Study who completed
treatment have shown promising results. Both patients
reported stable disease with a dramatic drop in their CA-125
protein levels of 89% and 98%. Cancer antigen 125 (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. A 50% reduction in CA-125 levels is
considered meaningful. Both patients' CA-125 levels were below the
normal healthy level of 35 U/mL. In addition, both patients
experienced successful surgical resections of their tumors with one
patient reporting a R0 resection which indicates a microscopically
margin-negative resection in which no gross or microscopic tumor
remains in the tumor bed.
The OVATION Study 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. Celsion has initiated four clinical sites
at the University of Alabama at
Birmingham; Oklahoma University
Medical Center; Washington University
in St. Louis and the Medical
College of Wisconsin. The trial is designed to enroll three
to six patients per dose cohort 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®.
GEN-1 + Avastin® + Doxil® Program
The Company has completed various preclinical studies combining
GEN-1 with Avastin® and Doxil®, the current standard of care for
the treatment of platinum resistant ovarian cancer, which has
demonstrated synergistic anti-cancer effects. The Company's
preclinical data abstract summarizing these studies has been
accepted for presentation at the upcoming AACR Annual Meeting 2016
in New Orleans. Data from these studies will be used to
support an IND filing for a Phase I/II clinical trial evaluating
the combination in recurrent ovarian cancer later this year.
Supporting Translational Data
In January 2016, the Company
reported translational research data from its recently completed
Phase 1b Study of GEN-1 in combination with PEGylated doxorubicin
(Doxil®) in patients with platinum-resistant ovarian cancer. This
important data provides evidence that
intraperitoneally-administered GEN-1 produces an immunologically
distinct IL-12 protein that is localized at the tumor site and
lasts for up to one week after a single treatment.
Furthermore, concomitant increases in IFN-γ and TNF-
α indicate that the IL-12 produced following treatment with
GEN-1 treatment is immunologically active.
In addition to this strongly supportive translational data,
GEN-1 has demonstrated encouraging safety and efficacy data in this
Phase 1b trial in combination with Doxil® as summarized below:
- Findings from this trial demonstrated an overall clinical
benefit of 57.1% for all treatment arms, with a partial response
(PR) rate of 21.4% and a stable disease (SD) rate of 35.7%
- There was a 100% overall clinical benefit observed at the
highest dose cohort in this difficult-to-treat patient population
(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 Doxil®.
Business Update
The Company also reported a year-end cash position of
$20.1 million (unaudited) compared to
$24.1 million reported at the end of
the third quarter of 2015.
"Celsion continues to make significant progress across our
pipeline of directed chemotherapies, immunotherapies and RNA-based
therapies, which we anticipate will position the company to achieve
value-creating milestones in 2016," said Michael H. Tardugno, chairman, president and
CEO. "As we look toward 2016, we will continue to maintain
tight controls over our spending with a sharp focus on those
programs that will drive both near-term and long-term value for our
shareholders."
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.
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