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UPDATE 2-Delcath gets FDA nod to resume enrollment in trials
(Recasts, adds details, updates share movement)
Nov 20 (Reuters) - Drug delivery systems maker Delcath Systems Inc (DCTH.O) said U.S. health regulators allowed the company to resume patient enrollment in the late- and mid-stage trials of its system used in the treatment of certain liver cancers, sending shares up 47 percent.
In October, the U.S. Food and Drug Administration had recommended a temporary suspension of patient enrollment in the trials after Delcath reported four serious adverse events, including two deaths, in a late-stage trial.
The principal investigator at the National Cancer Institute presented an analysis of the previously reported gastrointestinal toxicities and the changes incorporated into the trial protocols to prevent a recurrence of toxicities to the regulators.
The New-York based Delcath has been notified by the FDA that the studies can proceed with the amended protocol.
The mid- and late-stage trials use 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.
Shares of the company were up 68 cents at $2.13 in afternoon trade, making them the top percentage gainer on the Nasdaq. (Reporting by Esha Dey in Bangalore and Neha Pathania; Editing by Vinu Pilakkott, Deepak Kannan)
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