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Celsion Begins Patient Enrollment in Ovarian Cancer Study

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Celsion CorporationCLSN announced that it has enrolled the first patient in a phase Ib dose escalating clinical trial, OVATION.

The study will combine GEN-1, with the standard-of-care for the treatment of newly-diagnosed patients suffering from ovarian cancer, who will undergo neoadjuvant chemotherapy. GEN-1 is Celsion's DNA-based immunotherapy.

The study is being conducted to identify a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an immune response.

The trial will enroll three to six patients per dose level, and evaluate safety and efficacy of the therapy. It will also determine an optimal dose for a follow-on phase I/II study combining GEN-1 with Avastin and Doxil.

Moreover, the study aims to assess how cytokine-based compounds such as GEN-1 directly affects ovarian cancer cells and the tumor microenvironment in newly diagnosed patients.

Celsion plans to initiate the trial in two additional sites in the coming months. Interim results from the study are expected in the fourth quarter of 2015. Additionally, Celsion expects to continue the study into the first half of 2015 with higher doses of GEN-1.

Earlier, Celsion had reported positive safety and encouraging results from a phase I study with GEN-1, when given as monotherapy in patients with peritoneally metastasized ovarian cancer and in combination with PEGylated doxorubicin in patients suffering from platinum-resistant ovarian cancer.

Meanwhile, GEN-1 also showed preclinical activity in glioblastoma multiforme (brain cancer). Consequently, Celsion plans to initiate a phase I study.

We note that Celsion's lead program, ThermoDox, is currently in a phase III study for primary liver cancer and a phase II study for recurrent chest wall breast cancer.

Celsion currently carries a Zacks Rank #2 (Buy). Other favorably placed stocks in the health care sector include Abbott Laboratories ABT , AbbVie Inc. ABBV and Novo Nordisk A/S NVO . All three carry the same rank as Celsion.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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