Shares of Celsion Corp. (CLSN: Quote) have had an impressive performance for the year to date period, gaining more than 200%, thanks to a pivotal phase III study, which is progressing well.
For readers who are new to Celsion, here's what to expect in the coming months...
The late-stage trial, dubbed HEAT Study, is evaluating the company's lead product ThermoDox for primary liver cancer, and is being conducted under a Special Protocol Assessment with the FDA.
ThermoDox is a proprietary heat-activated liposomal encapsulation of chemotherapy drug Doxorubicin. ThermoDox has orphan drug designation in the U.S as well as in Europe. Celsion has a Development, Product Supply and Commercialization Agreement for ThermoDox with Yakult Honsha Co. in Japan.
In the HEAT study, the efficacy of ThermoDox in combination with RFA (radio frequency ablation) is compared with RFA alone in treating patients with primary liver cancer. The primary endpoint is progression free survival, or PFS, with a secondary confirmatory endpoint of overall survival.
A total of 380 PFS events are required to reach the unblinding and planned final analysis of the study. According to Celsion, the 380 PFS events are projected to occur in the fourth quarter of 2012, followed by announcement of top line results of the HEAT study.
The HEAT study, which is fully enrolled with 701 primary liver cancer patients, has a Fast Track Designation from the FDA as well as a Priority Trial status for liver cancer assigned by the National Institutes of Health.
The HEAT study also forms the basis for submission of a marketing authorization application for ThermoDox in primary liver cancer in Europe.
Last month, Celsion received FDA clearance to commence a phase II study of ThermoDox in combination with Philips' Sonalleve MR-HIFU (MR-guided high intensity focused ultrasound) in bone cancer. The study is expected to be initiated in the second half of 2012.
In January of this year, Celsion initiated a phase II study of ThermoDox in combination with radiofrequency ablation for the treatment of colorectal liver metastases.
ThermoDox is also being evaluated in recurrent chest wall breast cancer in a study known as DIGNITY. The company is slated to provide a clinical update of the phase I/II DIGNITY trial studying ThermoDox for breast cancer at the ESMO 2012 Congress, to be held in Vienna, Austria from September 28 to October 2, 2012.
A quick look at the company's balance sheet...
Celsion has incurred significant losses and negative cash flows from operations. In the quarter ended June 30, 2012, the company's loss narrowed to $6.1 million or $0.18 per share from $6.9 million or $0.42 per share in the same period of 2011. No licensing revenue was recognized in Q2, 2012 and the year-ago comparable quarter.
CLSN has thus far hit a 52-week low of $1.63 and a 52-week high of $5.24. The stock closed Monday's trading at $5.14, up 0.78%.
Will ThermoDox live up to expectations in the HEAT study? Stay tuned...
Celsion Corp: Basking In The HEAT
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by RTT Staff Writer
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