More efficacy and fewer side-effects are the goals of any oncology treatment. The company we are profiling today - Celsion Corp. (CLSN), is also focused on developing more efficient, effective oncology treatments by optimizing chemotherapeutics through improved delivery.
The company's proprietary heat-activated liposomal technology enables delivery of higher concentrations of proven chemotherapy drugs directly to the tumor to help stop the progression of cancer and minimize toxicity.
The lead product of Celsion is ThermoDox, which is under phase III testing for primary liver cancer and under a phase I/II study for recurrent chest wall breast cancer. 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.
The late-stage trial evaluating ThermoDox for primary liver cancer, dubbed the "HEAT Study", is being conducted under a Special Protocol Assessment with the FDA and is designed to enroll 600 patients at 76 clinical sites.
In the United States, 20,000 cases of primary liver cancer are diagnosed each year while there are about 40,000 such cases per year in Europe. The standard treatment for liver cancer is surgical removal of the tumor. Unfortunately, the majority of patients with liver cancer are ineligible for surgery. Minimally invasive therapy like radio frequency ablation is increasingly used to treat non-resectable liver tumors. However, the treatment is less effective for larger tumors. The non-surgical therapeutic treatment options like radiation therapy and chemotherapy have only limited efficacy to treat primary liver cancer.
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 with a secondary confirmatory endpoint of overall survival. The HEAT study has a Fast Track Designation from the FDA.
As of May 2011, the HEAT study had enrolled 93% of the 600 patients. According to Celsion, the next key events in its clinical timeline, include, a pre-planned interim efficacy analysis mid-year, followed by the top-line results in 2012.
As mentioned earlier, ThermoDox is also being evaluated in recurrent chest wall breast cancer in a study known as DIGNITY. Earlier this month, an independent Drug Safety Monitoring Board recommended advancing the DIGNITY study from phase I to phase II. The safety data review has established 50 mg/m2 of ThermoDox as phase II dose.
The DIGNITY study is a multicenter, single-arm trial designed to enroll up to 109 patients with recurrent chest wall breast cancer. The study evaluates the potential for ThermoDox in combination with hyperthermia to provide local control of superficial breast cancer recurrence. The primary endpoint is durable complete local response.
If things pan out the way as expected, the company plans to submit its New Drug Application for ThermoDox pursuant to Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. The 505(b)(2) regulatory pathway allows a sponsor to rely, at least in part, on the FDA's findings of safety and/or effectiveness for a previously approved drug (the "reference drug").
Given the promise ThermoDox holds in a wide variety of indications where heat-based therapy has demonstrated efficacy, Celsion believes ThermoDox is effectively a pipeline in itself.
Now, a quick look at the company's balance sheet...
The company has incurred significant losses and negative cash flows from operations. At March 31, 2011, Celsion had an accumulated deficit of $104.4 million, total current assets of $3.7 million (including cash and short term investments of $2.1 million) and current liabilities of $6.9 million. In order to fund its ongoing trials and complete the pre-planned interim efficacy analysis of the HEAT study, Celsion made an equity offering of $8.6 million in May.
According to a recent SEC filing, the company expects to use $16 million to $18 million of cash through the first quarter of 2012.
Celsion shares have thus far hit a 52-week low of $1.98 and a 52-week high of $3.87. The stock is currently trading around $3 on a volume of 92 thousand shares.
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