Biotech Mailbag: Study Boosts ImmunoGen

I can't think of one, Alex, and I'd be very wary of any company that claims it can't release or discuss phase III data prior to an Food and Drug Administration submission.

This is a stunt that my old nemesis Introgen Therapeutics (INGN Quote) tried a few years ago. On a quarterly conference call, management insisted that the FDA frowned upon companies presenting phase III data publicly before filing the data with regulators.

That's utter nonsense. Did the FDA get mad at Genentech when it presented breakthrough Avastin colon cancer data to thousands of cancer researchers in the spring of 2003 -- before filing for approval?

No.

Biotech investing is hard enough with the level of transparency investors get today, so if a company tries to pull a black curtain over something as important as phase III clinical data, there is some funny business going on.

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Raj C. asks, "Is Cell Genesys (CEGE Quote) pretty much finished after the FDA-ordered halt of its Phase III clinical trial for GVAX? Or does it have other promising drugs in the pipeline?"

I usually spend a good bit of Wednesday afternoon writing the Mailbag, so this is what I typed in response to Raj's email:

Cell Genesys is pretty much finished because its GVAX cancer vaccine technology doesn't work. That's been my humble opinion for a long time, but a pretty good one, it turns out, after the company was forced to halt one of its prostate cancer vaccine trials in August due to more deaths attributable to GVAX Prostate.

The next shoe to drop (again, my humble opinion) will be the halt to the other GVAX Prostate study dubbed VITAL-1. A futility analysis for this study is being conducted which will show that GVAX Prostate has no chance of improving survival over the control arm in which patients are receiving the chemo drug Taxotere. Cell Genesys' partner, the Japanese drug firm Takeda, will then file for divorce.

After that, Cell Genesys will most definitely be done.

After writing the above Wednesday, it amused me to no end to wake up Thursday morning to the news that Cell Genesys was shutting down the VITAL-1 study because GVAX Prostate doesn't work.

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Today's last email from Vitas. "Adam, since Epicept (EPCT Quote) got European approval for Ceplene, what is your opinion of their prospects?"

Persistence pays off. For those not familiar with the history here, Ceplene was once owned by Maxim Pharmaceuticals, a San Diego drug firm with a less-than-stellar reputation. Ceplene was a two-time failure in melanoma, but Maxim believed the drug had a future as a remission extender for patients with acute myeloid leukemia (AML).