FDA halts Halozyme's pancreatic cancer study

Wed Apr 9, 2014 8:33am EDT

A view shows the U.S. Food and Drug Administration (FDA) logo at the lobby of its headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed

A view shows the U.S. Food and Drug Administration (FDA) logo at the lobby of its headquarters in Silver Spring, Maryland August 14, 2012.

Credit: Reuters/Jason Reed

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(Reuters) - Halozyme Therapeutics Inc said the U.S. Food and Drug Administration ordered a halt on a study of its drug delivery system in pancreatic cancer patients, barely a week after the company voluntarily stopped the trial.

The company's shares fell about 3 percent to $8.06 in trading before the bell.

Halozyme said on April 4 that it had temporarily stopped the trial after the recommendation of an independent safety board, which was assessing a possible difference in the rate of blood clots found in patients receiving Halozyme's treatment and those receiving approved cancer treatments.

The company said on Wednesday that it was gathering information related to the issue and would provide it to the safety monitoring committee and the FDA.

The mid-stage study was testing a more potent form of the company's existing technology to deliver chemotherapy drugs intravenously and to prolong the effectiveness of its synthetic enzyme, Hylenex, in the blood stream.

The company's shares, which fell 32 percent the day it halted the study, closed at $8.29 on the Nasdaq on Tuesday.

(Reporting By Vrinda Manocha in Bangalore; Editing by Don Sebastian)

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