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Vic R. asks for an ImmunoGen ( IMGN) update after Tuesday's third-quarter earnings report from Genentech ( DNA).

Genentech's pipeline update Tuesday brought good news for ImmunoGen when the company announced that it was advancing T-DM1 into a phase III study as a second-line treatment for Her-2 positive metastatic breast cancer.

Recall that Genentech is using technology from ImmunoGen to develop a second-generation version of Herceptin that combines the monoclonal antibody with a tumor-killing chemotherapy payload. That drug is T-DM1.

The newly announced phase III study will enroll 580 Her-2 positive metastatic breast cancer patients who have failed first-line treatment with Herceptin. Patients will be randomized to treatment with either T-DM1 or a combination of GlaxoSmithKline's ( GSK) Tykerb and the chemo drug capecitabine. The primary endpoint of the study is progression-free survival.

Explained simply, this new phase III study is designed to pit T-DM1 head to head against Tykerb, which is currently the only drug approved to treat breast cancer patients whose tumors continue to grow after treatment with Herceptin.

One more T-DM1 update to note. Genentech will be presenting updated phase II data on T-DM1 at the San Antonio Breast Cancer Symposium in December.

Biotech Select

ImmunoGen is a long pick in the Biotech Select model portfolio. My investment thesis hinges largely on Genentech pushing ahead with development of T-DM1, so Tuesday's announcement was very important -- and very welcome.

ImmunoGen shares fell 10% Wednesday, which isn't exactly the reaction I wanted to see, but then, this market isn't too friendly to small-cap biotech stocks, as we know all too well.

From Alex S.: "Why, and under what circumstances, would a company release important Phase III trial data only after they submit a new drug application for their product?"

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) 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?


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.

Raj C. asks, "Is Cell Genesys ( CEGE) 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.

Today's last email from Vitas. "Adam, since Epicept ( EPCT) 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).

Unfortunately, Maxim was basically out of business, so the company merged with Epicept, a New Jersey drug firm, in 2005. Epicept ran with Ceplene in AML and after an initial rejection in Europe, regulators there finally approved the drug in October.

Epicept doesn't have a European commercial partner to sell Ceplene yet, so I'd wait to see if the company can land one, and at what price.

The Ceplene data in AML dates back to 2004 and doesn't make a very strong case for the drug's efficacy. That's because the phase III study treated AML patients with a combination of Ceplene and interleukin-2 making it unclear which drug, or the combination, was truly helping AML remain in remission longer.

It's partly for this reason that Maxim was never able to see FDA approval for Ceplene in AML, and why so far, neither has Epicept. It also helps explain Epicept's sub-$1 stock price.

One more note: After my Onyx Pharmaceuticals ( ONXX) item in last week's Mailbag, I heard from the company's head of investor relations Julie Wood that the company, on the second-quarter conference call, raised sales guidance for Nexavar to a range of $660 million to $675 million. In my column, I had the current guidance at $600 million to $650 million, so my mistake.

The consensus Nexavar sales estimate for the third quarter remains in the $175 million range.

At the time of publication, Feuerstein's Biotech Select model portfolio was long ImmunoGen and Genentech.

Adam Feuerstein writes regularly for In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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