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Halozyme Therapeutics, Inc.
today announced that it has resumed enrollment and dosing of patients in
its ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with
pancreatic cancer under the revised clinical protocol agreed to with the FDA
in June. PEGPH20 is an investigational PEGylated form of Halozyme's
proprietary recombinant human hyaluronidase under development for the systemic
treatment of tumors that accumulate hyaluronan.
"Our diligent effort to rapidly re-initiate patient enrollment and dosing of
both previously enrolled and new patients in this trial underscores our
commitment to evaluating the potential role of PEGPH20 in patients with stage
4 metastatic pancreatic cancer. Approximately 50% of the anticipated clinical
sites have received IRB approvals, and we anticipate continued IRB approvals
in the coming weeks," commented Dr. Helen Torley, President and Chief
Executive Officer.
Study 202 Trial Design
Study 202 (Halo 109-202) is a Phase 2 multicenter, randomized clinical trial
evaluating PEGPH20 as a first-line therapy for treatment of patients with
stage 4 metastatic pancreatic cancer. The primary outcome of the trial is to
measure improvement in progression-free survival in patients receiving PEGPH20
in combination with gemcitabine and nab-paclitaxel compared to gemcitabine and
nab-paclitaxel alone. A second primary endpoint will assess the thromboembolic
event rate in the PEGPH20 treatment arm. Secondary endpoints also include
objective response rate and overall survival.
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