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Celgene Halts Drug Trial Over Blood Clot Fears

Posted on: Wednesday, 28 September 2005, 21:00 CDT

By Kathleen Lynn, The Record, Hackensack, N.J.

Sep. 29--A clinical trial of Celgene Corp.'s experimental drug Revlimid has been suspended amid concerns over blood clots.

Participants in the trial will now be required to take aspirin, which lowers the risk of clotting. Previously, they had been advised to take aspirin, Celgene spokesman Brian Gill said Wednesday.

The independent trial, which has 250 participants so far, is testing Revlimid's effectiveness against multiple myeloma.

The Wall Street Journal reported Wednesday that the investigators in the study had found a higher-than-expected incidence of blood clots in the study's participants. The study is being conducted by the National Cancer Institute, and is expected to resume within a few weeks, Gill said.

Shares of Summit-based Celgene fell $1.26 Wednesday to $52.85.

Celgene stock has recently been boosted by Revlimid's prospects. This month, an advisory panel of the Food and Drug Administration recommended approval of the drug to treat myelodysplastic syndrome, a life-threatening disorder in which the bone marrow fails to make enough healthy blood cells.

Although the FDA is not required to follow the recommendations of its advisory panels, it usually does.

The FDA is expected to decide on the Revlimid application Oct. 7. If approved by the FDA, the drug is expected to have sales of about $206 million in 2006, adding 10 cents a share to the company's earnings, now estimated at about $1 per share.

Revlimid is a form of thalidomide, the drug that caused birth defects when taken by pregnant women decades ago. Celgene already sells another form of thalidomide under the name Thalomid, which is used to treat myeloma and leprosy. The company has developed a protocol that doctors use when prescribing Thalomid to guard against its use by pregnant women.

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Copyright (c) 2005, The Record, Hackensack, N.J.

Distributed by Knight Ridder/Tribune Business News.

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CELG, DJ,

Source: The Record - Hackensack, New Jersey

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