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Celsion Announces Impressive Preclinical Data for its GEN-1 IL-12 Immunotherapy in Combination with Avastin® and Doxil® for Ovarian Cancer

LAWRENCEVILLE, N.J., Oct. 12, 2015 /PRNewswire/ -- Celsion Corporation (CLSN), an oncology drug development company, today reported data from a large preclinical study of the Company's GEN-1 IL-12 immunotherapy in combination with Avastin® and Doxil® for the treatment of ovarian cancer. Results from the comprehensive studies confirmed remarkable initial GEN-1 + Avastin findings and show convincingly that GEN-1 when combined with Avastin® and Doxil®, standard of care for platinum resistant patients, demonstrated a greater than 98% reduction in tumor burden when compared to the untreated control group. The findings represent a statistically significant reduction in tumor burden and disease progression when compared to the combination of Avastin® and Doxil® in a SKOV3 human cell line implanted into immunocompromised (nude) mice.

"The immune stimulating nature of GEN-1 in combination with Avastin® and Doxil® makes for an ideal therapy, bolstering the anti-cancer effect beyond what has been observed when used alone," said Nicholas Borys, M.D., senior vice president and chief medical officer of Celsion. "Results from this study are highly encouraging and suggest that when these therapies are combined, they offer the potential to significantly reduce tumor burden and disease progression in this highly aggressive cancer in patients who have failed first line platinum-based therapies."

The study was designed to evaluate in a mouse model of disseminated ovarian cancer, the efficacy of a combined treatment regimen that consisted of weekly administrations of GEN-1 with therapeutically relevant doses of Doxil® and Avastin®. In the study, the combination of GEN-1 with Avastin® and Doxil® demonstrated a robust anti-tumor advantage compared to untreated animals as well as a statistically significant improvement over the combination of Avastin® and Doxil® as summarized below:


Reduction in Mean


Percentage of Animals

with No Visible Tumors


Tumor Burden



vs. Untreated Control


GEN-1 Immunotherapy

84%


50%

Avastin® + LD Doxil®

77%


12%

Avastin® + HD Doxil®

88%


50%

Avastin® + LD Doxil® + GEN-1

>98%


75%

Avastin® + HD Doxil® + GEN-1

>98%


75%





LD – Low Dose; HD – High Dose

Analysis of serum chemistry and hematology suggested no overt toxicities associated with the combined treatments. The preclinical data are consistent with the mechanism of action for GEN-1, which exhibits certain anti-angiogenic properties in addition to its...


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