LAWRENCEVILLE, N.J., March 12, 2015 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, today announced financial results for the year ended December 31, 2014 and provided an update on its development programs for ThermoDox®, its proprietary heat-activated liposomal encapsulation of doxorubicin, and two newly acquired technology platforms, TheraPlas and TheraSilence, in immunotherapy and RNA delivery. The Company’s lead program is ThermoDox® which is 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 Company’s immunotherapy program consists of GEN-1, 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 and is currently under development for the localized treatment of ovarian and brain cancers.
“We enter 2015 well-positioned as we continue to make significant progress in our ongoing clinical, regulatory and business strategies. With the substantial and growing support from the medical and scientific community, the encouragement of key regulatory bodies in the United States, Europe and Asia, a strong balance sheet, and impressive overall survival data from the HEAT Study, we are especially encouraged by progress in our clinical development program for ThermoDox in both primary liver cancer and RCW breast cancer,” said Michael H. Tardugno, Celsion’s president and CEO. “The immunotherapy and RNA therapy platforms that we gained when we acquired EGEN provide synergy, complementary assets and multiple opportunities to create additional value for our shareholders, and we look forward to advancing GEN-1 into a first-line ovarian cancer study mid-year and to the prospect of a high potential GBM program shortly thereafter.”
Recent Pipeline Developments
ThermoDox®
Reported Convincing Updated Survival Data from Phase III HEAT Study. As of January 15, 2015, the latest quarterly overall survival (OS) analysis demonstrated that in a large, well bounded, subgroup of patients (n=285, 41% of the study patients), the combination of ThermoDox® and optimized RFA provided a 59% improvement in OS compared to optimized RFA alone. The Hazard Ratio at this analysis is 0.628 (95% CI 0.420 - 0.939) with a p-value of 0.02. This data continues to suggest that ThermoDox® may significantly improve OS compared to a RFA control in patients whose lesions undergo optimized RFA treatment for 45 minutes or more.
“These findings provide a strong rationale for the ongoing OPTIMA Study and may also underscore the interest of clinical investigators to evaluate the potential of ThermoDox plus optimized RFA for curative intent among intermediate stage HCC patients,” noted Riccardo Lencioni, MD, FSIR, EBIR, professor and director of the diagnostic imaging and intervention at the Pisa University School of Medicine in Italy.
Partnered with myTomorrows to Introduce the ThermoDox® Early Access Program (EAP) in Europe. In January 2015, Celsion announced a license and distribution agreement with myTomorrows to implement an EAP for ThermoDox® in all countries of the European Union territory plus Switzerland for the treatment of patients with recurrent chest wall (RCW) breast cancer. The Company expects to have ThermoDox® available in the second quarter of 2015 for sales to physicians who are treating patients with limited therapeutic options. The EAP provides physicians with access to products in later stage development demonstrating evidence of clinical benefit, with an acceptable safety profile and a quality manufacturing process in place. Celsion will be allowed to price ThermoDox at commercial rates.
Advancing Plans to Launch the DIGNITY Study in Europe. Reflecting remarkable overall response rates in prior studies of patients with refractory disease, Celsion remains on track to initiate the Euro-DIGNITY Trial of ThermoDox® plus hyperthermia in patients with RCW breast cancer in the first half of 2015. The study will be conducted in five countries with the eventual objective of an RCW breast cancer label for ThermoDox. Celsion will conduct the trial with the support of key European investigators and with assistance from MedLogics Corporation, an Italian-based hyperthermia device company.
Expanded Pivotal OPTIMA Study in Europe. In September 2014, Celsion announced that the first patient had been enrolled in its pivotal Phase III OPTIMA Study of ThermoDox® in combination with optimized radiofrequency ablation (RFA) in patients with primary liver cancer. In November 2014, the OPTIMA Study was approved via Europe’s centralized Voluntary Harmonization Procedure, allowing the Company to begin enrolling patients at 14 clinical sites in Germany, Italy, France and Spain. The Company is aggressively initiating sites in North America, Europe and Asia Pacific and expects to enroll 550 patients at up to 100 clinical sites in 13 countries.
GEN-1 Immunotherapy
Announced Plans for a Phase Ib Study for GEN-1 in First-Line Ovarian Cancer. In February 2015, Celsion announced that the U.S. Food and Drug Administration (FDA) has accepted, without comment, its planned Phase Ib dose-escalation clinical trial of GEN-1 in combination with the standard of care in neo-adjuvant ovarian cancer, which is expected to commence in mid-2015 at five to six U.S. clinical centers. The study will evaluate safety and efficacy and attempt to define an optimal dose and an enhanced patient population to carry forward into a Phase 2 trial.
Presented Phase Ib Data for GEN-1 in Platinum-Resistant Ovarian Cancer. The Company presented preliminary data from its recently completed study of GEN-1, its IL-12 coded DNA plasmid nanoparticle, in combination with pegylated doxorubicin in 16 patients with platinum-resistant ovarian cancer at the Molecular Medicine TRI-Conference in February 2015. The findings demonstrated that there were no overlapping toxicities between GEN-1, its subsequent immune system activation, and pegylated doxorubicin. An abstract for this study detailing efficacy findings and clinical response results has been submitted to ASCO for its upcoming annual conference in the second quarter.
Ongoing Preclinical Studies in GBM to Support IND Filing in Mid-2015. Celsion is conducting comprehensive preclinical studies to support an Investigational New Drug (IND) application for clinical studies of its immune system activator, GEN-1, in glioblastoma multiforme (GBM). As currently conceived, the Phase I study would provide GEN-1 for local administration, recruiting the immune system to combination with temozolomide to treat post-surgical patients. The study will recruit chemotherapy naive patients, whose immune system is theorized, will respond actively to IL-12 DNA-based immunotherapy.
TheraSilence
Presented Preclinical Data for TheraSilence Platform at the miRNA World Conference Workshop on miRNA Delivery. In October 2014, Celsion highlighted formulation characteristics of its TheraSilence delivery platform, preclinical proof-of-concept data and data supportive of GEN-2 at the miRNA World Conference Workshop on miRNA Delivery.
Financial Results
For the year ended December 31, 2014, Celsion reported a net loss of $25.5 million, or $1.38 per share, compared to a net loss of $12.9 million, or $0.95 per share, in 2013. Operating expenses were $25.2 million in 2014 compared to $15.9 million in 2013. Operating expenses in 2014 included a $1.4 million one-time charge in connection with the acquisition of the assets of EGEN, Inc. In 2013, Celsion recorded an $8.1 million non-cash gain related to the change in the common stock warrant liability compared to a $0.2 million non-cash gain in the current year.
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