FDA Places Clinical Hold on Halozyme’s PEGPH20 Pancreatic Cancer Trial

Thu, 04/10/2014 - 8:58am

Halozyme Therapeutics, Inc. has announced that the  FDA has  informed the company that a clinical hold has been placed on patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer.  According to the FDA, this action was being taken in view of the company's recent decision to temporarily halt enrollment and dosing of PEGPH20 in the Phase 2 trial.
"As announced earlier, we are gathering information relevant to assessing the possible difference in the thromboembolic event rate between the patients treated with PEGPH20 versus the patients treated without PEGPH20 in the trial.  We will be providing this information to the Data Monitoring Committee and the FDA in parallel so they can complete their respective assessments," stated Dr. Helen Torley, President and CEO.  "Pancreatic cancer has one of the lowest survival rates of any cancer.  We remain committed to evaluating PEGPH20 as a possible therapy to address this devastating disease."


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