- The Washington Times - Monday, June 2, 2003

CHICAGO (AP) — Shares of two cancer-drug makers soared yesterday on news that their experimental treatments were effective in clinical trials.

ImClone Systems Inc. stock rose more than 17 percent a day after a study presented at the American Society of Clinical Oncology showed that doctors concluded Erbitux, the cancer drug that enmeshed ImClone Systems in an insider trading scandal, worked just as well as an earlier company-sponsored study said it did.

Separately, researchers released a study of Genentech’s experimental drug Avastin, which showed the drug modestly lengthened survival by cutting off a tumor’s blood supply. Genentech shares jumped more than 6 percent yesterday.

Research on treatment targeting a tumor’s blood supply was developed around the idea that cancer needs a growing network of blood vessels to survive — a theory championed by Harvard University’s Dr. Judah Folkman. According to the theory, shutting down the process, called angiogenesis, should arrest tumors and even obliterate them.

“This is a landmark announcement,” said Dr. William Li, head of the nonprofit Angiogenesis Foundation. “It’s the first true validation in a well-designed clinical trial that cutting off a tumor’s blood supply can improve cancer survival.”

The treatment is an antibody aimed at vascular endothelial growth factor, or VEGF, one of the more than 20 chemicals that help tumors’ blood vessels grow and survive.

The study, directed by Dr. Herbert Hurwitz of Duke University, involved 925 colon cancer patients who all received chemotherapy. They were also randomly given either Avastin or a placebo.

Those on Avastin survived an average of 20 months, compared with nearly 16 months for those getting only standard treatment. The results were a surprise, because an earlier study found no benefit of Avastin against breast cancer.

In another major cancer study, this one involving ImClone’s drug Erbitux, questions that led to the Food and Drug Administration’s December 2001 rejection of the drug’s approval appear to have been answered.

Erbitux is one of a new class of cancer medicines designed to work with pinpoint accuracy against the molecule-level defects that make the disease flourish. It is an antibody that jams cancer’s complex interplay of chemical growth signals.

In ImClone’s initial study, Erbitux was tested on people with advanced colon cancer who had already failed to respond to irinotecan, a chemotherapy drug. Researchers believed Erbitux could restore some of the chemotherapy’s punch.

While the data showed nearly a quarter of patients responded to the combination, the FDA turned back ImClone’s application for approval, saying Erbitux alone might have worked just as well. It also questioned whether all the patients had truly failed on chemotherapy.

The new study was conducted on 329 colon cancer patients who had clearly failed to respond to irinotecan, based on strict definitions. They were given either Erbitux alone or in combination with irinotecan.

It found 23 percent getting the combination and 11 percent taking Erbitux alone responded to treatment, meaning their tumors shrank by at least half. However, the effect was typically brief. Median survival was nearly nine months for those on the combination and seven months for patients getting only Erbitux.

Shares of ImClone rose $5.00 to close at $33.50 on the Nasdaq Stock Market, adding to a 21 percent gain Friday on published reports of good results. Genentech shares gained $4.12 to close at $66.73 on the New York Stock Exchange.

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