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Biotech Stock Mailbag: Celsion Short Thesis, Hemispherx

The authors do caution intravenous doxorubicin may have limited drug exposure at the tumor site. Thermodox might increase doxorubicin concentration in the tumor but, again, success would break a long losing streak for any chemotherapy in primary liver cancer. [Full citation: Heptatol Int (2011) 5:567-574]

These are the main reasons why my fund manager source believes the Thermodox still will fail. He is short Celsion. I don't expect everyone to agree with him, but if you're a Thermodox believer and are betting on success in the phase III trial, it's still vital to know what the other side of the trade is thinking.

Celsion is expected to announce top-line results from the Thermodox study in January.

Ted starts his email quoting previous comments I made skeptical of Hemipsherx Biopharma (HEB - Get Report):

The only attention Hemispherx is getting comes from day traders and biotech "run-up" traders anticipating the Dec. 20 FDA advisory panel for the company's chronic fatigue syndrome therapy Ampligen. [At 5%, Hemispherx has even less institutional investor support than Galena Biopharma.] This FDA panel isn't likely to end well for Ampligen, just like Hemispherx's previous stabs at getting Ampligen approved based on overly massaged data from a failed clinical trial.

Ted disagrees:

"You are so [bleeping] biased!" he writes. "What makes you think FDA panel will vote against Ampligen? How about those millions of people suffering from CFS? Have you had any conversation with any of them to better understand Ampligen? Drug is safe and has no side effects. Why would the panel vote against it?"

Ampligen is already available to people suffering from chronic fatigue syndrome today, but it's barely used. If Ampligen is safe and effective, as the relatively few Hemispherx bulls contend, why aren't more CFS patients being treated with it?

Since May 1997, FDA has allowed Hemispherx to administer Ampligen to CFS patients under a "compassionate use" exception. Hemispherx is even allowed to recoup costs associated with Ampligen so that compassionate use isn't a financial burden on the company.

In the first nine months of 2012, 33 CFS patients were on Ampligen therapy, according to Hemispherx regulatory filings. In 2001, the number was 36. In 2010, 21 patients took the drug. In 2009, Ampligen was used by 18 patients, according to Hemispherx.

The availability of Ampligen today torpedoes the bull thesis that insists, falsely, that FDA will grant the drug full approval under newly enacted provisions in the FDA Safety and Innovation Act (FDASIA.) FDA long ago took steps to make Ampligen available but patients don't want it!
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