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jbog

06/22/09 6:56 PM

#79809 RE: drbio45 #79807

AF set his tone to go after scams starting with Ingn years ago.


The highlight for me from Thursday's conference call sponsored by Introgen Therapeutics (INGN Quote) came when Canaccord Adams' analyst Joe Pantginis -- he's a table-thumping Introgen bull -- said the following about Advexin, Introgen's gene therapy drug for head and neck cancer:

"So, thanks again for being on the call and just a quick question -- as with all novel technologies, there continues to be some skeptics out there. I would really love to get the views of our experts regarding an existing comment that exists currently that Advexin just doesn't work."

I was flattered, naturally, because the "existing comment" Pantginis referred to is mine, although he didn't capture its full flavor.

What I wrote, back in a December Biotech-Stock Mailbag, was: "Introgen is a terrible company. Advexin is junk. The drug doesn't work. The data are manipulated and false. Management misleads."


Much juicier, don't you think?

The view of the experts assembled by Introgen for Thursday's call was unanimous in support for Advexin. The doctors, Jack Roth, John Nemunaitis, John Hamm and Jarrard Goodwin -- all either investigators in the Advexin phase III study or with hands-on experience using Advexin -- stated emphatically that Advexin works and that the drug will be approved.

Is it possible that these well-credentialed experts -- all with more letters after their names than me -- can be wrong? In the face of such overwhelming support for Advexin, how can I continue to be so negative?

Actually, it's quite easy.

Here's another biotech investing lesson courtesy of Introgen: Don't let so-called experts intimidate you into believing you're wrong when you have the facts and common sense on your side of the ledger. I'll take facts and common sense over a fancy medical degree and unsubstantiated opinion for hire any day when it comes to spotting a biotech blowup in the making.

Comparing Survival Data

Introgen claims that 75% of head and neck cancer patients have a readily identifiable genetic makeup, or biomarker, that allows them to benefit more from treatment with Advexin.

If that's true, then why did Advexin patients overall in the company's phase III study do so poorly? The median survival for Advexin-treated patients in the study was 4.4 months, compared to a median survival of 6.1 months for patients treated with the chemotherapy drug methotrexate, according to the intent-to-treat analysis of the study's primary endpoint.

Yes, Advexin's survival was numerically worse in this study.

On Thursday's call, Introgen's science chief Bob Sobol said survival between Advexin and methotrexate was "similar." Really? A patient on Advexin surviving for 4.4 months compared to a methotrexate patient living 6.1 months is similar?

Does common sense tell you that this survival difference is similar? If I was dying of head and neck cancer and was enrolled in this study, I know which treatment arm I'd want to be in. Hint, it wouldn't be Advexin.

Now, of course, Introgen's whole schtick is about the genetic biomarker that identifies patients who benefit more from the drug. Much of Thursday's discussion focused on data purporting to show how a subset of patients in the study -- dubbed "Advexin favorable" patients -- reported a median survival of 7.2 months, significantly longer than the subset of "Advexin unfavorable" patients with a median survival of 2.7 months.

Still, this doesn't explain why survival for Advexin-treated patients overall was so low. Introgen says that 75% of head and neck cancer patients are "Advexin favorable" so surely, that should translate into a survival benefit no matter how the patients are analyzed.

After all, it's not like Introgen is claiming that Advexin only works in a minority of head and neck cancer patients


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Adam Feuerstein
Goodbye Introgen
12/4/2008 8:39 AM EST



This may be a bit self-indulgent, so my apologies, but I need to mention here for posterity sake that Introgen Therapeutics (INGN) filed for Chapter 11 bankruptcy yesterday. This marks a first in my journalistic career. I've covered other biotech stock frauds all the way down to the bulletin boards and been around as executives faced various SEC charges, but Introgen is the first company that I've ever helped push into bankruptcy.

The "helped" part might be me being a bit presumptuous but I'd like to think that my years of following Introgen and warning investors about the bamboozlement being committed at the company by management played a part in its demise.

And the biotech sector is a better place with Introgen fading away.