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cancer drug fails trial

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    Isis, Lilly Cancer Drug Fails Trial
    Monday March 17, 5:08 pm ET
    By Toni Clarke and Ben Hirschler

    NEW YORK/LONDON (Reuters) - Eli Lilly & Co. and Isis Pharmaceuticals Inc. said on Monday their experimental lung-cancer drug failed a late-stage trial, in a blow to one of the most closely watched technologies in the drug industry.

    Patients taking Isis's drug, Affinitak, together with conventional chemotherapy, did not live significantly longer than those undergoing chemotherapy alone.

    Isis, based in Carlsbad, California, has staked its future on the potentially revolutionary "antisense" technology, meant to work at the genetic level to block production of disease-causing proteins. Scientists have been toiling for decades to develop the technology, so far with little success.

    Several big drug companies, including Lilly, Amgen Inc. and Aventis SA, have partnered with antisense drug developers in the hope that the technology might finally be maturing. Isis' lung cancer trial could undermine that confidence, analysts say.

    "It's an extremely elegant theory, but it's also extremely complicated -- more so than anyone realized," said Quynh Pham, an analyst at Delafield Hambrecht Inc. "I don't foresee anything coming out of it any time soon."

    Isis shares fell $1.33, or 32 percent, to $2.83 on Nasdaq. Shares of Genta Inc., also using antisense technology to develop cancer drugs, fell 24 cents, or $3.86, to $6.45.


    Indianapolis-based Lilly, which agreed in 2001 to invest $200 million in the co-development of Affinitak, said it remains committed to investigating antisense technology, though it has not yet decided whether to continue its own late-stage trial of the lung cancer drug.

    Shares of Lilly, a much larger drug company than either Isis or Genta, rose $1.32, or 2.45 percent, to $55.30, in a broadly higher market.

    Isis Chairman and Chief Executive Stanley Crooke, who has spearheaded antisense research in the face of skepticism from many scientists, refused to be daunted.

    "We've had a disappointing trial here. But if we look at all the data, we are absolutely convinced that antisense technology works," he said in an interview.

    Most conventional drugs work by inhibiting proteins. The idea behind antisense is to interfere at the genetic level to prevent rogue proteins being formed in the first place.

    Some analysts said the real cause of the failure could be the target of the drug's activity, in this case a protein known as PKC-alpha. Related proteins may also have to be neutralized for such a therapy to work, they said.

    "I don't think the trial failed because of the antisense technology but because inhibiting the PKC-alpha target didn't work," said analyst David Bouchey at C.E. Unterberg, Towbin.


    Others agree, saying there is no reason the failure of Isis' drug should mean others should fail also.

    Genta, backed by Aventis, is using the technology to develop drugs for blood, skin, colon, breast, lung, lymph and prostate cancer. Late-stage clinical data from its trials in multiple myeloma, melanoma and chronic leukemia are expected this summer.

    Mark Monane, an analyst at Needham & Co., which conducts investment banking for both companies, said the Isis drug and Genta drugs are not similar. "Genta is going after a completely different target," he said.

    Ray Warrell, Genta's chief executive, said he was not disheartened by the Isis trial. He insists his company's target has shown as over-expressed in a wide variety of cancers, including lung cancer, and is confident Genta will succeed where Isis stumbled.

    Even so, many once-promising antisense drugs have failed, including experimental therapies from Isis for HIV and genital warts. Isis developed the only commercial antisense drug -- a treatment for a rare type of eye infection in AIDS patients.

    Isis has another 11 antisense drugs in development, but some of those programs might have to be cut so it can conserve enough funds to bring forward its leading candidates, analysts said.

    The company plans to update its financial forecasts in April.

    "We have sufficient financial resources that this is a bump in the road. It is not a catastrophe," Crooke said, noting Isis has some $392 million in cash and cash commitments. The group made an operating loss of $52 million in 2002.

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