FDA Plays

[newtostocks23]

$CLSN – My brief Celsion Corporation DD

Friday's open $3.18
Friday's close $3.13
52-week high $3.87
52-week low $1.98
Market capitalization 61.5M
Avg. volume (10-day) 448.0K
Shares outstanding 19.6M

In my opinion, the investment of Celsion at this price with this market capitalization is an absolute steal. Currently, the company is conducting a pivotal Phase III clinical trial for primary liver cancer and a Phase II study for recurrent chest wall breast cancer.

If you’ve ever read any of my previous postings you’d see that I like to tailor my DD for the average investor who doesn’t want to spend countless hours researching the research material to decipher it. I also like to keep it short and simple. So with that being said, here’s a quick glance of why I believe this could be a great investment opportunity.

So what is Thermodox?
- Imagine if you will, that you can take an FDA approved chemotherapy drug Doxorubicin and be able to target just the tumor in a much higher concentration (up to 30 times greater than free drug & 3-5 times greater than traditional liposomes) with less exposure to other areas. This is what the Thermodox treatment is. Doxorubicin is coated in a liposomal encapsulation that only melts away when heated by inducing mild hypothermia (hyperthermia means a body temperature that is higher than normal). Radiofrequency ablation (RFA) is the most commonly used type of local hyperthermia. RFA is used to heat up the region of the tumor and therefore releasing the high concentration of the chemotherapy drug to attack the tumor.


Product of Interest to Me
Thermodox: A proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers including breast cancer. ThermoDox® is administered intravenously and in combination with hyperthermia. Localized mild hyperthermia (39.5-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.

CATALYST(s): Interim Analysis - Sept 2011 – (ref: http://bit.ly/kB8gMW Page 14)
OTHER CATALYST(s): Trial enrollment Halt due to sufficient data.
MY BRIEF RISK ANALYSIS: Medium to Below Average for Sept interim. For a longer term investment, your risk increases.

Bear Side: The company has had a couple share offerings in the past couple of months and Thermodox has not previously completed any phase 3 trials. Of the available data involving humans, only 1 patient was treated for primary liver cancer and 5 others for metastatic liver disease. Therefore, little data is available involving humans.

Bull Side: The phase 3 trial is being conducted under a SPA (Special Protocol Assesment) so a trial design failure is reduced significantly. Doxorubicin is already a FDA approved chemotherapy drug, RFA is already used medical procedures, and Liposomal technology has been used since the 1990’s. Celsion is only introducing a capsulated form of the same drug in conjunction with mild hypothermia and releasing the drug in the tumor site. Also, take note of insider buying in the last few months indicating insider confidence in their product.

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DD Links
Celsion Website
http://bit.ly/m92tKL

Celsion 2011 Annual Shareholder Meeting
http://bit.ly/jBY6I9

Griffin Securities Report
http://bit.ly/mfWlRS

Gekkowire's Celsion CLSN report
http://bit.ly/mEQAoI

Biotech Stock Mailbag: Celsion (Adam Feuerstein)
http://bit.ly/kE6qbv

Thermodox Video
http://bit.ly/kUeQLQ

Celsion's ihub page
http://bit.ly/jEuQgp

Insider trades
http://bit.ly/lk8pNU



Other Resource Links
Radiofrequency Ablation of Hepatic Tumors: Increased Tumor Destruction with Adjuvant Liposomal Doxorubicin Therapy
http://bit.ly/mqaG45

Radiofrequency ablation of small hepatocellular carcinoma with intravenous pegylated liposomal doxorubicin
http://1.usa.gov/kjTSv6

Multi-targeting cancer chemotherapy using temperature-responsive drug carrier systems
http://bit.ly/mQ3lCL