http://www.nytimes.com/2003/05/20/business/20PLAC.html?th

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Eric

Success for New Cancer Drug
By ANDREW POLLACK


drug that starves tumors of oxygen and nutrients has prolonged the lives of
patients with colorectal cancer in a clinical trial, providing what doctors said
yesterday was the first convincing validation of a new approach to treating
cancer.

The results of the late-stage clinical trial, announced yesterday by the drug's
developer, Genentech, came as a surprise to many analysts and scientists because
the tumor-starving approach had failed to work in many previous attempts.
Genentech itself had failed in using its drug, Avastin, to treat breast cancer.

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But yesterday Genentech said that patients given Avastin along with conventional
chemotherapy lived significantly longer than those who were given the
chemotherapy alone. The benefit "far exceeded what the study was designed to
demonstrate," the company said.

Genentech's stock soared 45 percent as securities analysts, many of them
previously skeptical of Avastin, quickly reversed themselves and upgraded their
ratings of the company. Genentech shares closed up $16.95, to $54.85, its
highest level since January 2002.

"This is to my knowledge the first major randomized study that validates the
concept" behind Avastin and similar drugs, said Dr. Leonard Saltz of Memorial
Sloan-Kettering Cancer Center in New York, an authority on colorectal cancer.
"And that is huge."

Still, he said, Avastin will probably extend lives by only a few months. "Cancer
is not cured," he said, but added, "If we keep making those modest incremental
steps forward, after a while the steps add up."

Avastin works by blocking the formation of blood vessels that deliver oxygen and
nutrients that tumors need to grow. This approach to cancer treatment generated
great excitement in 1998 after a front-page article in The New York Times
described the success of Dr. Judah Folkman, a professor at Harvard and
Children's Hospital in Boston, in eradicating tumors in mice using drugs other
than Avastin.

But in testing in people, seven such drugs failed in Phase 3 clinical trials,
the final stage of testing, said Dr. William Li, president of the Angiogenesis
Foundation, a nonprofit organization in Cambridge, Mass., that promotes the
blocking approach to cancer treatment. Angiogenesis is a scientific term for the
formation of blood vessels.

Dr. Li said there were 65 drugs in clinical trials that work at least partly by
blocking angiogenesis. Besides Avastin, two other drugs, one developed by
Aeterna Laboratories of Quebec City, Canada, and the other by Novartis, the
Swiss drug giant, are in Phase 3 trials.

Dr. Li said the earlier failures might have been because drug companies had not
yet learned how to apply the technique. "We don't know what the right targets
are," he said. "We don't know what the right drugs are. We don't know what the
right tumors are. And we don't know who the right patients are," he said. "We're
feeling our way through this."

Dr. Folkman, who has been working on anti-angiogenesis drugs for 30 years,
called the Genentech news exciting but said he never doubted the approach would
work. Some other drugs that have shown effectiveness against cancer, like
thalidomide to treat multiple myeloma, work at least partly by blocking blood
vessel formation, he said. But the Avastin results provide a clear proof, he
said, because Avastin "is a pure angiogenesis inhibitor."

Because of the results of the Phase 3 trial, analysts said Genentech, a
biotechnology company based in South San Francisco, Calif., would be able to
apply soon for approval of Avastin. The drug could then be on the market early
in 2004, sooner than expected.

"This is going to change the way we think about treating cancer patients," said
Dr. Susan Desmond-Hellmann, the company's chief medical officer. "We'll look
back and say this day was history."

Genentech has several other drugs that could be approved in the next year, like
Raptiva for psoriasis and Xolair for asthma, which won the endorsement of a Food
and Drug Administration advisory committee last week.

But Avastin is probably the most important for the company because of its sales
potential, which some analysts put at more than $1 billion a year, and because
Genentech will receive all the profits from the drug. It must share Raptiva and
Xolair profits with other companies.

Genentech did not announce the detailed results from the clinical trial, which
will be presented at the American Society of Clinical Oncology meeting starting
May 31 in Chicago. The conference, which took the unusual step of accepting the
Avastin paper as a last-minute submission, prohibits scientists from releasing
details in advance.


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