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Celgene stock rises amid drug trial data speculation

BOSTON
Tue Apr 3, 2007 5:27pm EDT

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BOSTON (Reuters) - Shares of biotechnology company Celgene Inc. (CELG.O) rose more than 3 percent on Tuesday amid speculation that a clinical trial of its cancer drug Revlimid is being stopped early because the results are so positive.

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A trial known as ECOG-E4A03 is testing Revlimid in newly diagnosed patients with the bone marrow cancer multiple myeloma, in combination with either a high dose of the steroid dexamethasone or a low dose of dexamethasone.

Matthew Osborne, an analyst at Lazard Capital Markets, said it appears the Eastern Cooperative Oncology Group (ECOG), which is conducting the trial, has sent a letter to clinical investigators suspending the trial based on positive results from a recent analysis.

"Some have speculated today that the benefit is based on a safety advantage, which may be the case, but we believe the trial will stop early due to the low-dose dexamethasone/Revlimid arm demonstrating the more important survival benefit," Osborne said in a research report.

Officials at Celgene and ECOG were not immediately available for comment.

Full results from the trial are expected to be presented at the annual meeting of the American Society of Clinical Oncology in June.

Revlimid is a successor to Celgene's drug Thalomid, currently the leading treatment for multiple myeloma. Revlimid is approved to treat patients with multiple myeloma who have failed other therapies.

While companies are not allowed to market a drug for unapproved uses, doctors are allowed to prescribe them "off label" as they see fit.

"Survival benefit, if reached, could speed off-label adoption for Revlimid in front-line multiple myeloma," Osborne said.

Thalomid plus dexamethasone is typically the first choice of treatment for newly-diagnosed patients ahead of a stem cell transplant.

Investigators have suspected that Revlimid in combination with dexamethasone will prove more effective than the Thalomid regime, cause fewer side effects and become the standard of care for patients with newly diagnosed multiple myeloma.

Celgene's shares closed up $1.83, or 3.4 percent, at $55.63 on the Nasdaq.



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