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Another Setback for Cancer Vaccines

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[Disappointing since the science seems so compelling]

Cancer 'Vaccine' Is Set Back as Treatment Fails in Trial

By ANDREW POLLACK and TOM WRIGHT

Published: April 7, 2005

LOS ANGELES, April 6 - A cancer treatment that has been under

development for more than 40 years failed in the first clinical trial

in which it was compared with a placebo. The failure, announced

Wednesday, was a blow to the field of so-called cancer vaccines and

to the two companies developing the treatment, Serono and CancerVax.

Serono, Europe's biggest biotechnology company, also said Wednesday

that it had ended testing of an experimental psoriasis drug after a

patient died.

In more positive news, the team of Biogen Idec, Genentech and Roche

said their drug, Rituxan, which is already being used to treat non-

Hodgkin's lymphoma, succeeded in a late-stage clinical trial as a

treatment for rheumatoid arthritis, possibly opening up a big market

for the drug.

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Those results could particularly benefit Biogen Idec, which is still

reeling from the withdrawal from the market of the multiple sclerosis

drug Tysabri. The drug has been linked to a rare but deadly brain

disease.

Cancer vaccines, unlike vaccines for childhood diseases, generally do

not aim to prevent cancer but rather to enlist the body's immune

system to fight tumors after they have started to grow. While the

idea sounds enticing, many experimental vaccines have stumbled in

clinical trials and none have been approved in the United States.

The one that failed in the clinical trial, Canvaxin, is one of the

most advanced in testing. Dr. L. Morton, medical director of

the Wayne Cancer Institute in Santa , Calif., has been

working on it since the 1960's.

In earlier tests, Canvaxin seemed to improve the survival rate of

people with melanoma, a deadly skin cancer. But those tests were not

randomized controlled trials, the gold standard for gauging new

drugs. So CancerVax, a biotechnology company based in Carlsbad,

Calif., has been running two such Phase 3 trials, usually the last

stage of testing before a drug is approved; Dr. Morton is a co-

founder of CancerVax.

However, CancerVax said on Wednesday that an independent committee

monitoring one of those trials recommended that it be stopped, even

before it had finished enrolling patients, because it was not likely

that people getting the drug would live meaningfully longer than

those getting the placebo.

Executives of both CancerVax and Serono, which licensed the rights to

Canvaxin in December, said that they were still optimistic that the

drug would work in the second trial. In that trial the patients'

melanoma is not as advanced as in the failed trial, perhaps making

the cancer more vulnerable to the vaccine. Data from that trial is

expected around the middle of next year.

" I'm disappointed but not discouraged, " Dr. Morton said.

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