San Diego, CA -- (SBWire) -- 11/10/2020 --An investor, who purchased NASDAQ: CLSN shares, filed a lawsuit over alleged violations of Federal Securities Laws by Celsion Corporation.
Investors who purchased shares of Celsion Corporation (NASDAQ: CLSN) have certain options and for certain investors are short and strict deadlines running. Deadline: December 28, 2020. NASDAQ: CLSN investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.
Celsion's lead product candidate is ThermoDox, a heat-activated liposomal encapsulation of doxorubicin that is in Phase III clinical development for treating primary liver cancer.
In February 2014, Celsion Corporation announced that the U.S. Food and Drug Administration ("FDA") had reviewed and provided clearance for the Company's planned pivotal, double-blind, placebo-controlled Phase III trial of ThermoDox in combination with radio frequency ablation ("RFA") in primary liver cancer, also known as hepatocellular carcinoma ("HCC"), called the "OPTIMA Study." The trial design was purportedly based on a comprehensive analysis of data from the Company's Phase III HEAT Study, which purportedly demonstrated that treatment with ThermoDox resulted in a 55% improvement in overall survival ("OS") in a substantial number of HCC patients that received an optimized RFA treatment.
The OPTIMA Study was expected to enroll 550 patients globally, with up to 100 sites in the U.S., Europe, China and Asia Pacific, to evaluate ThermoDox in combination with RFA. The primary endpoint for the trial was OS, and the statistical plan called for two interim efficacy analyses by an independent Data Monitoring Committee ("DMC").
On July 13, 2020, Celsion Corporation announced that "it ha[d] received a recommendation from the independent [DMC] to consider stopping the global Phase III OPTIMA Study of ThermoDox® in combination with [RFA] for the treatment of [HCC], or primary liver cancer." According to the Company, "[t]he recommendation was made following the second pre-planned interim safety and efficacy analysis by the DMC on July 9, 2020," which "found that the pre-specified boundary for stopping the trial for futility of 0.900 was crossed with an actual value of 0.903."
The plaintiff claims that between November 2, 2015 and July 10, 2020, the Defendants made false and/or misleading statements and/or failed to disclose that Defendants had significantly overstated the efficacy of ThermoDox, that the foregoing significantly diminished the approval and commercialization prospects for ThermoDox, and that as a result, the Company's public statements were materially false and misleading at all relevant times.
Those who purchased shares of Celsion Corporation (NASDAQ: CLSN) have certain options and should contact the Shareholders Foundation.
Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com
About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, , which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigation, and/or settlements are not filed/reached and/or related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.
NASDAQ:CLSN Investor Alert: Lawsuit Alleges Securities Laws Violations by Celsion
A lawsuit was filed on behalf of investors in Celsion Corporation (NASDAQ:CLSN) shares over alleged securities laws violations.