Celsion's Immunotherapy Candidate Impresses, Stock Surges
Zacks Investment Research | Oct 04, 2017 12:24AM ET
Celsion Corporation (NASDAQ:CLSN) announced results from phase Ib study — OVATION — evidently showing biological activity of its immunotherapy candidate, GEN1, in advanced ovarian cancer patients. Celsion is developing the candidate for newly diagnosed patients, who will be administered in combination with neoadjuvant chemotherapy.
Investors cheered the news as the stock skyrocketed over 300% on Tuesday. In fact, shares of the company have surged 42.4% so far this year, outperforming the industry ’s rally of 15.2% during the period.
The OVATION program was designed to identify a safe, tolerable and therapeutically active dose of GEN-1 for 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 reflected a 100% disease control rate (DCR) and an 86% objective response rate (ORR). Of the five patients treated in the highest dose cohort, there was 100% objective response rate with one patient achieving complete response and four, affirming partial responses.
The company also announced improvement in median progression free survival (PFS), which increased from 12 months to 18 months with longest PFS of 24 months. Plus, GEN1 brought favorable immunological changes that are likely to get translated into clinical benefit.
The company met with advisory board last month and based on their recommendation is planning to file the phase II design with the FDA by this year-end.
Celsion is also developing the candidate in combination with PEGylated doxorubicin for patients with platinum-resistant ovarian cancer.
Apart from GEN-1 immunotherapy, another cancer program in Celsion’s portfolio is ThermoDox, currently being investigated in a phase III evaluation for primary liver cancer.
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