Halozyme Therapeutics Inc. (HALO) got the green light from the
U.S. Food and Drug Administration to resume its clinical trial of
pancreatic cancer drug PEGPH20.
The San Diego biopharmaceutical company temporarily halted
enrollment in the Phase 2 trial in April as a precaution following
a recommendation from an independent data monitoring committee.
The committee reviewed clinical data that indicated a difference
in the thromboembolic event rate between patients treated with
PEGPH20 and those treated without PEGPH20. Last month, the
committee recommended the trial be resumed under a revised
protocol, which would look into the rate of blood clots in both
groups of patients and exclude those at a higher risk of developing
blood clots. Additionally, the company will use low-molecular
weight heparin to prevent blood clots.
More than 100 patients with stage IV metastatic pancreatic
cancer had been already enrolled in the trial. The company said it
expects to enroll a similar number of additional patients.
Shares rose 11% to $9 in recent after-hours trading. Through
Wednesday's closing, shares were up 25% over the past 12
months.
Write to Maria Armental at maria.armental@wsj.com
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