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Celgene cancer drug clinical trial suspended – WSJ

September 28, 2005

NEW YORK (Reuters) – A clinical trial of Celgene Corp.’s
experimental cancer drug, Revlimid, has been suspended because
of concerns about blood clots, the Wall Street Journal reported
on Wednesday.

The suspension comes as the company was awaiting notice
from the Food and Drug Administration (FDA) next week on
approval of the medicine, the newspaper said.

It quoted the principal investigator in the study, S.V.
Rajkumar, an oncologist at the Mayo Clinic, as saying he could
not comment on how many patients experienced blood clots. But
he told the Journal he expected the trial would resume shortly.

The trial of 250 patients examines Revlimid’s
effectiveness, in combination with a steroid, in patients with
multiple myeloma, a cancer of the plasma cells in bone marrow.

Celgene declined to comment on the report, the newspaper
said.

The Journal cited two other people familiar with the study
as saying it was suspended when a higher incidence of blood
clots — or deep-vein thrombosis — was seen in participants.

Trial organizers were concerned that patients were not
uniformly taking aspirin, which lessens the risk of clotting,
and which had been recommended to them. The trial was suspended
until the rules were rewritten to mandate the use of aspirin,
those close to the trial told the newspaper.

They expect the trial, funded by the National Cancer
Institute, to resume in a few weeks.

The suspension of the trial comes at a critical time for
Warren, New Jersey-based Celgene, which is hoping for approval
next week of Revlimid for transfusion-dependent anemia in a
subset of patients with myelodysplastic syndrome, a rare blood
disorder that predisposes patients to acute leukemia.

The problem with blood clots presents a potential dilemma
for the FDA, the Journal said. Even though the company is
applying for approval of the drug in myelodysplastic syndrome,
doctors expect that once approved, the treatment will be used
much more widely in combination with a steroid in patients with
multiple myeloma, as in Rajkumar’s trial.

An FDA spokeswoman declined comment but noted that the
agency generally only weighed the risks and benefits of a drug
in the disease and patient group for which it was being
considered for approval.




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