Celsion Corporation
Jan 17, 2017

Celsion Announces Continuing Positive Data from the OVATION Study in Newly Diagnosed Advanced Ovarian Cancer Patients

Fourth Cohort of Patients Continues to Show Clinically Meaningful Responses in the Evaluation of GEN-1, A Novel IL-12 DNA-based Immunotherapy, in Combination with the Standard of Care

LAWRENCEVILLE, N.J., Jan. 17, 2017 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ:CLSN) today announced data from the fourth cohort of patients in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company's IL-12 gene-mediated immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with Stage III and IV ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery.  In the first twelve patients dosed in the OVATION Study, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer.

"These early results have impressed our investigators which accounts for the rapid patient accrual in the study.  The consistency and robust nature of the data across all four cohorts and the encouraging clinical responses underscore the potential of GEN-1 to serve as an effective, safe IL-12 immunotherapy in ovarian cancer," said Nicholas Borys, M.D., Celsion's chief medical officer. "In particular, we see improvements across a number of important and meaningful measures used to assess ovarian cancer, which reinforce our confidence in this IL-12 immunotherapy approach and provide a strong rationale for continued development of GEN-1 for the treatment of ovarian cancer. We look forward to the translational data which, along with the clinical findings, will assist in the design of our registrational program."

The OVATION Study is designed to enroll three to six patients per dose cohort with the goal of identifying a safe, tolerable and immunologically active dose of GEN-1 by recruiting and maximizing an immune response. The first four cohorts have each enrolled three patients.  Enrollment in the fourth cohort is ongoing with the goal of enrolling three additional patients in this final dose cohort.  Celsion expects to complete enrollment in the OVATION Study this quarter and report final data, including translational data for all patients in the second quarter of 2017. Future studies of GEN-1 will include a Phase I/II study combining GEN-1 with Avastin® and Doxil®.

OVATION Study - Totality of Results in the First Four Patient Cohorts

OVATION Study - Top Line Translational Data from First Two Cohorts

Celsion previously reported initial translational data from the first two cohorts of the OVATION study.  Tumor and blood samples collected before the start of the neoadjuvant chemotherapy (NACT) and after the completion of GEN-1 treatment at debulking surgery are being analyzed for immune cell populations.  Top line data demonstrates intriguing immunological changes in the tumor that are consistent with the activation of the immune system.  For example, the ratio of CD8+/FoxP3+ cells was increased in all four evaluable patients.  High tumor infiltrating CD8+ T-cell density, low FoxP3+ T-cell density or high CD8+/FoxP3+ ratio demonstrate a potential shift in tumor environment to favoring immune stimulation following NACT + GEN-1 therapy.  For the remaining two patients the post-treatment tumor tissue was not available.  In one of those two patients there was complete pathological response hence no tumor tissue was present to provide a post-treatment comparison.  In the other patient the debulking surgery was not performed due to disease related complications.  Complete immune analysis of biological tissue including cytokine ELISA from all four patient cohorts is in progress.

"These results build on the impressive clinical findings we observed in our earlier GOG Study as well as the translational data from this same study. As we move closer towards the final design of a Phase I/II trial to evaluate the synergistic anti-cancer effects of GEN-1 together with Avastin® and Doxil®, these results also provide strong clinical evidence for the potential of GEN-1 in ovarian cancer," said Michael H. Tardugno, Celsion's chairman, president and chief executive officer. "We anticipate completion of enrollment in the fourth and final patient cohort in the coming quarter. In parallel, we are currently collecting full translational data from the study, which we expect to report in the first half of this year."

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 gene-mediated 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 the Celsion's periodic reports and prospectuses filed with the Securities and Exchange CommissionCelsion 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

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Source: Celsion Corporation

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