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Celsion's Phase I/II Cancer Study Initiation Gets FDA Nod
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Celsion Corporation 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 (JNJ - Free Report) Doxil and Roche Holding AG’s (RHHBY - Free Report) 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.
Sucampo’s earnings per share estimates have increased from 3 cents to $1.12 for 2017 and from $1.15 to $1.19 for 2018 over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 15.63%. The company’s stock is up 72.7% in the past six months.
Zacks Editor-in-Chief Goes "All In" on This Stock
Full disclosure, Kevin Matras now has more of his own money in one particular stock than in any other. He believes in its short-term profit potential and also in its prospects to more than double by 2019. Today he reveals and explains his surprising move in a new Special Report.
Image: Bigstock
Celsion's Phase I/II Cancer Study Initiation Gets FDA Nod
Celsion Corporation 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 (JNJ - Free Report) Doxil and Roche Holding AG’s (RHHBY - Free Report) 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.
Celsion Corporation Price
Celsion Corporation Price | Celsion Corporation Quote
Zacks Rank & Key Pick
Celsion carries a Zacks Rank #2 (Buy).
Sucampo Pharmaceuticals, Inc. is another top-ranked health care stock, carrying Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sucampo’s earnings per share estimates have increased from 3 cents to $1.12 for 2017 and from $1.15 to $1.19 for 2018 over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 15.63%. The company’s stock is up 72.7% in the past six months.
Zacks Editor-in-Chief Goes "All In" on This Stock
Full disclosure, Kevin Matras now has more of his own money in one particular stock than in any other. He believes in its short-term profit potential and also in its prospects to more than double by 2019. Today he reveals and explains his surprising move in a new Special Report.
Download it free >>