One of the most important medical meetings is fast approaching, and it couldn't come soon enough for the ailing biotech and drug sectors.
We're talking about the annual meeting of the American Society of Clinical Oncology, which runs May 18-21 in Orlando, Fla. ASCO, as it's known, is the Super Bowl of cancer research confabs, where clinical oncologists -- and yes, Wall Street analysts and fund managers -- come to discuss the latest and greatest cancer treatments.
The American Stock Exchange Biotech index is off 20% for the year, beaten down by a flood of bad news about drugs being rejected, delayed or otherwise not living up to expectations. The ASCO meeting, then, represents the first real shot this year to get the drug and biotech sectors moving in a positive direction.
While the ASCO confab is still more than a month away, preliminary research abstracts for the meeting will be released April 15. As always, ASCO tries to keep a tight lid on these findings, but they leak out. There are more than 3,500 research papers discussed at the meeting, but here's a preview of some of the companies that have the early chatter.
: Last year's ASCO meeting was the company's coming-out party for the now-infamous cancer drug Erbitux. ImClone reveled in the spotlight, and even feted doctors with a Doobie Brothers concert.
Well, we all know what's happened since then, so in many ways, this year's meeting is even more important for the embattled biotech firm. ASCO tends to be a hospitable environment for ImClone because oncologists have generally lauded Erbitux despite its regulatory hiccups. This year, the company has a full slate of new data to present, which will either bolster this bullish view or knock some holes in it.
ImClone will present data from a pair of phase two trials in colon cancer: a small, 30-patient pilot study testing Erbitux in combination with a three-drug chemotherapy cocktail; and another study testing Erbitux as monotherapy, results of which were included in the rejected Erbitux application to the Food and Drug Administration.
But the biggest ASCO buzz is being saved for expected results from a Phase III test of Erbitux in head and neck cancer, conducted by the Eastern Cooperative Oncology Group, an independent research consortium. This study tests 123 patients with either the chemo drug cisplatin or a combination of cisplatin and Erbitux.
The fact that this study is late-stage, blinded, randomized and is not being conducted by ImClone gives it lots of scientific weight. The results from this study could end a lot of the debate about whether Erbitux is a real drug or not.
Also on the head-and-neck cancer front, ImClone will release final results from a Phase II trial testing Erbitux in combination with the chemotherapy drug cisplatin. Preliminary results from this trial were disclosed at last year's ASCO meeting.
: The company is developing a technology that delivers higher, more effective doses of existing cancer drugs to tumors, while reducing their toxic side effects. (Think about what's happened to aerial warfare since satellite and laser-guided navigation systems were strapped to normally dumb, 500-pound bombs, and you get the idea.)
At ASCO, Cell Therapeutics will take the wraps off several midstage test results for PG-TXL, which combines the new technology -- a naturally occurring polymer called polyglutamate, with the blockbuster cancer drug placitaxel. The tests are being conducted in patients suffering from many different types of solid tumor cancers, most notably ovarian and colorectal cancers.
: The company's agenda for this year's meeting is still in flux. The biggest news out of Genentech could be results from a phase three test of its promising antiangiogenesis drug, Avastin, in advanced breast cancer patients. The 400-patient study compares patients taking the breast cancer drug Xeloda versus patients taking a combination of Xeloda and Avastin.
Alas, Genentech is still not sure whether results will be ready in time for release at ASCO. The company will also discuss its other experimental cancer drug, Tarceva, but none of the data will be new. Tarceva is being codeveloped by
: Look for new, Phase II trial results from ABX-EGF, another experimental cancer drug that targets the epidermal growth factor receptor. (ImClone's Erbitux and Genentech's Tarceva do too.) Abgenix will take the wraps off data testing ABX-EGF in renal cell cancer.
-- soon to merge with
-- is the codevelopment partner for ABX-EGF.
: Its proteasome inhibitor, MLN341, looked good at last year's American Society of Hematology confab, based on early results from a Phase II study testing the drug in refractory multiple myeloma patients. More detailed results from this study are expected at this year's ASCO.
Another company developing a cancer drug, dubbed Iressa, that targets the epidermal growth factor receptor. ImClone's delay is supposed to be AstraZeneca's gain, but that really depends on the quality of its data.
Final results from the second of two, Phase II studies of Iressa in non-small cell lung cancer patients will be presented this year. This U.S. study, plus one conducted earlier in Europe and Japan, forms the basis for an approval application filing to the Food and Drug Administration.
reported earlier by
, AstraZeneca pulled some key, Phase III Iressa test data from ASCO this year. Why? The company's not talking, but it will certainly be a prime topic of conversation at the meeting.