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FDA Launches Inquiry Into Telik Trial

The Food and Drug Administration has launched an inquiry to determine whether Telik (TELK) violated federal law by failing to disclose patient deaths in a recent ovarian cancer study, has learned.

Women taking Telik's experimental drug Telcyta died five months faster than similar women in the study's control arm, according to data presented publicly for the first time on June 3 at the annual meeting of the American Society of Clinical Oncology.

But Telik's management knew since December 2006 -- five months before presenting the data at ASCO -- that Telcyta might be harming ovarian cancer patients instead of helping them. This information was never publicly disclosed.

Furthermore, Telik failed to share the data with the FDA, according to a senior official with the agency.

Concerned for patient safety, the FDA ordered Telik last week to halt all ongoing clinical studies involving Telcyta.

"It is unclear to us at this point whether regulations or laws may have been broken, but we're looking into the matter seriously," said the FDA official, who asked to remain unnamed.

"Sophisticated companies would have reported data like this to us in a timely manner," the FDA official added. "The fact that we learned of this [the Telcyta patient deaths] at the ASCO meeting will adversely affect the company in the future because we can't trust them."
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