This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Biotech Stock Mailbag: Celsion Short Thesis, Hemispherx

Celsion is conducting a phase III study in which 600 patients with hepatocellular carcinoma, also known as primary liver cancer, are being treated with Thermodox plus RFA or RFA alone. The primary endpoint of the study is to determine if the addition of Thermodox to RFA can significantly delay the re-growth of liver tumors compared to treatment with RFA alone.

RFA is a procedure often used by doctors to ablate, or remove, relatively small tumors from the liver that can't otherwise be excised surgically. While RFA can be curative, liver cancer can and does recur because some cancer cells remain in the surrounding tissue and start growing again. Celsion believes the addition of Thermodox to RFA will kill enough of the cancer cells in the liver adjacent to the tumor to prevent or delay the return of the cancer.

The Thermodox study will fail, my "short Celsion" fund manager source predicts, because more often than not, tumors grow back in distant parts of the liver away from the lesion(s) that's been ablated using RFA and Thermodox.

"Thermodox is like shooting at a rhinoceros with a pellet gun," he says.

A 2008 paper published in the Journal of Gastrointestinal Surgery (Ng, et al.) followed 192 primary liver cancer patients who had successful and complete tumor ablation following RFA procedures. With a median follow-up of more than two years, only 15% of patients had local tumor recurrence, meaning the cancer returned at the same spot in the liver targeted by the RFA ablation. The majority of patients (56%) experienced liver tumor regrowth in parts of the liver that were not targeted by RFA ablation. Ten percent of patients developed cancer metastases outside the liver while 18% remained recurrence-free. Full citation: J Gastrointest Surg (2008) 12:183-191

If this pattern of distant liver tumor recurrence holds true in Celsion's study (and Mr. Short Celsion thinks it will), Thermodox will be unable to demonstrate a significant benefit on delayed tumor progression in the phase III study.

The use of doxorubicin as the cancer-killing payload in Thermodox is also suspect given the drug's failure to produce any positive benefit on disease-free survival in previous liver cancer trials, he says. A 2011 study published in Hepatology International (Jing-Houng, et al.) showed pegylated liposomal doxorubicin administered intravenously in conjunction with RFA had no beneficial impact on tumor progression or survival compared to RFA alone.

2 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG
CLSN $2.54 0.40%
HEB $0.24 1.30%
AAPL $130.12 0.12%
FB $82.44 2.48%
GOOG $540.36 0.22%

Markets

DOW 18,076.27 +64.33 0.36%
S&P 500 2,114.07 +4.47 0.21%
NASDAQ 5,099.2310 +22.7070 0.45%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs