UPDATE 2-Delcath - FDA asks to suspend enrollment in key trial

Tue Oct 23, 2007 12:54pm EDT

(Adds conference call details, updates share movement)

BANGALORE Oct 23 (Reuters) - Shares of Delcath Systems Inc (DCTH.O) lost about two thirds of their value Tuesday after the drug delivery systems maker said U.S. health regulators sought suspension of enrollment in a key trial in the treatment of certain liver cancers.

Delcath shares fell to their lowest in three-and-a-half years in morning trade on the Nasdaq. Later they recovered and were trading down $1.21 at $1.46 in afternoon trade.

The U.S. Food and Drug Administration also asked the company to submit an analysis of side effects in the trial, ahead of a meeting to discuss certain gastrointestinal safety concerns, the company said in a statement.

The FDA move comes after Delcath reporting four serious adverse events, including two deaths, in a late-stage trial.

None of the events occurred during the administration of Delcath procedure but happened afterwards, Chief Executive Richard Taney said in a conference call with analysts.

Delcath worked with the National Cancer Institute (NCI) to amend the protocols, which were approved by the Institutional Review Board at NCI on Sept. 18 and implemented in the trials. There have been no gastrointestinal toxicities in patients since then, Taney said.

The company said it was unsure if the FDA considered the amended protocols and related data while issuing the letter.

LIVER ISOLATED

The mid- and late-stage trials used Delcath System with the drug melphalan to isolate the liver from the general circulatory system to treat the tumors in the liver.

Under the treatment, catheters inserted through the skin are used to deliver drugs to the liver, block the flow of blood from the liver and then remove the drugs. This avoids the complications of a surgery and can be repeated if needed.

The FDA had approved the late-stage trial under a fast track designation and NCI was the lead center in the trial.

About 90 patients have been treated with Delcath procedure and the current enrollment is 60 patients. The NCI has performed 200 such procedures, CEO Taney said.

Delcath said it plans to meet with the FDA to address the issues and present changes that have already been made to the trial protocols, which it believes will remedy the agency's safety concerns.

The company expects patients currently enrolled in the trials will continue to receive their treatments under the approved protocols. (Reporting by Jennifer Robin Raj in Bangalore)

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