Celsion Completes Ovarian Cancer Trial Enrollment, Stock Up
Zacks Investment Research | Jul 06, 2017 02:15AM ET
Celsion Corp.’s (NASDAQ:CLSN) shares have rallied almost 20% on Wednesday after the company has announced a successful completion of enrollment in a phase Ib dose escalating study, evaluating its DNA-based immunotherapy, GEN-1 in combination with neoadjuvant chemotherapy for treatment of advanced ovarian cancer. This would allow a safety examination by the Company’s Data Safety Monitoring Board (DSMB) in mid-July this year.
The OVATION study was designed to identify a safe, tolerable and therapeutically active dose of GEN-1for future studies. The trial also assessed how cytokine-based compounds namely, GEN-1 directly affects ovarian cancer cells and the tumor microenvironment in newly diagnosed patients with Stage III and IV ovarian cancer, followed by an interval debulking surgery.
Of the 14 patients treated to date, two have demonstrated a complete response (CR), 10, a partial response (PR) and another two, a stable response. This showed a 100% disease control rate (DCR) and an 86% objective response rate (ORR). Of five patients treated in the highest dose cohort, there was a 100% objective response rate with one patient achieving complete response and four, showing partial responses.
The above research data was presented at the annual meeting of American Society of Clinical Oncology (ASCO) 2017.
However, Celsion’s shares have significantly underperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. The stock has plunged 43.1% compared with the broader industry’s increase of 8.1%.
With enrolment completion, the company remains on track for an investigational new drug (IND) submission for phase I/II clinical study, combining GEN-1 with Roche Holding (SIX:ROG) AG’s (OTC:RHHBY) Avastin and Doxil in the recurrent population of ovarian cancer patients.
Apart from GEN-1 immunotherapy, another cancer program in Celsion’s portfolio is ThermoDox. It is currently under scrutiny in a phase III study for primary liver cancer and a phase II study for recurrent chest wall breast cancer.
Zacks Rank & Key Picks
Celsion currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in healthcare space are Bayer (DE:BAYGN) AG (OTC:BAYRY) and Aduro BioTech, Inc. (NASDAQ:ADRO) . While Bayer sports a Zacks Rank #1 (Strong Buy), Aduro carries a Zacks Rank #2 (Buy). You can see .
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Bayer’s earnings per share estimates have inched up from $8.85 to $8.93 for 2017 and from $9.53 to $9.61 for 2018, over the last 30 days. The company has delivered positive earnings surprises in three of the four trailing quarters with an average beat of 10.25%. Shares of Bayer have soared 22.6% so far this year.
Aduro’s loss per share estimates has shrunk from $1.60 to $1.46 for 2017 in the last 60 days. The company has delivered positive earnings surprises in two of the four trailing quarters with an average beat of 36.28%.
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