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Shares of Celsion Corporation CLSN plunged 63.97% after it received a recommendation from the independent Data Monitoring Committee (DMC) to consider stopping its late-stage study for the treatment of hepatocellular carcinoma (HCC) or liver cancer.
The phase III OPTIMA study is a global, randomized, double-blind, placebo-controlled clinical study, assessing the efficacy of ThermoDox in combination with radiofrequency ablation (RFA), which was standardized to a minimum of 45 minutes for treating patients with a lesion 3-7 cm in size, versus standardized RFA alone.
The study enrolled 554 patients at 65 clinical sites in North America, Europe, China and the Asia Pacific. In addition to the primary overall survival endpoint, progression-free survival, time to disease progression and safety are key secondary endpoints.
ThermoDox is a proprietary heat-activated liposomal encapsulation of chemotherapy drug, doxorubicin, currently in phase III development for the treatment of primary liver cancer. It is also in development for other cancer indications.
The DMC conducted a second, pre-planned, interim safety and efficacy analysis on Jul 9, 2020, and then recommended to stop the study. The DMC analysis found that the pre-specified boundary for stopping the trial for futility of 0.900 was crossed with an actual value of 0.903. However, the 2-sided p-value of 0.524 for this analysis provides uncertainty. Hence, the final decision on the continuation of the trial was left on the company. Notably, there were no safety concerns noted during the interim analysis.
We remind investors that the statistical plan for the OPTIMA Study included two interim efficacy analyses by the DMC. The first interim analysis was announced in November 2019, following data lock in August 2019 after the prescribed minimum number of 128 patient events (deaths) was reached. This was the second interim analysis, following data lock in April 2020 after the prescribed minimum number of 158 events was reached.
The news disappointed investors as ThermoDox is Celsion’s lead program.
Celsion’s shares have declined 24.5% in the year so far compared with the industry’s growth of 6.4%.
The company’s product pipeline also includes GEN-1, a DNA-based immunotherapy, for the localized treatment of ovarian cancer. However, this is still in development stage and likely to face competition from established drugs like Roche’s RHHBY Avastin.
Zacks Rank & Key Picks
Celsion currently carries a Zacks Rank #4 (Sell). A couple of better-ranked stocks in the healthcare sector include Horizon Therapeutics HZNP and BioMarin Pharmaceuticals BMRN. Both carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Earnings estimates for BioMarin for 2020 are up by 2 cents in the past 30 days.
Earnings estimates for Horizon for 2020 are up by a cent in the past 30 days.
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Roche Holding AG (RHHBY) : Free Stock Analysis Report
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