Celsion's Phase I/II Cancer Study Initiation Gets FDA Nod
Zacks Investment Research | Jan 04, 2018 09:42PM ET
Celsion Corporation (NASDAQ:CLSN) announced that the FDA has accepted the design of its phase I/II study – Ovation II – in ovarian cancer and cleared it for initiation. The study will evaluate its DNA-based immunotherapy, GEN-1, as localized treatment for stage III/IV ovarian cancer in newly diagnosed patients.
Shares of the company opened 13% higher on Jan 5, following the announcement. In fact, Celsion’s shares are up 44.8% in the past six months, significantly outperforming the industry ’s gain of 1.6% during the period.
The FDA has cleared the study based on compelling data from a dose escalating phase Ib OVATION study evaluating GEN-1 in ovarian cancer. The candidate achieved comparable progression free survival (PFS) in patients versus neoadjuvant chemotherapy.
The OVATION II study is also a dose escalation study whose phase I part is designed to find suitable dose of GEN-1 while evaluating doses up to 100 mg/m2. The selected dose will be evaluated in the phase II part of the study. The primary endpoint of the study is to achieve at least 33% improvement in PFS in patients treated with GEN-1 in combination with neoadjuvant chemotherapy compared to neoadjuvant chemotherapy alone.
The company expects to initiate the study in the first half of 2018.
Celsion is also developing the candidate in combination with Johnson & Johnson’s (NYSE:JNJ) Doxil and Roche Holding (SIX:ROG) AG’s (OTC:RHHBY) Avastin for patients with platinum-resistant ovarian cancer.
Apart from GEN-1 immunotherapy, another cancer program in Celsion’s portfolio is ThermoDox, its lead pipeline candidate. It is currently being investigated in a phase III study for primary liver cancer and a phase II study for recurrent chest wall breast cancer.
The company has no approved product in its portfolio. Thus, investors remain focused on its pipeline progress.
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