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Shares Of Halozyme Up 14% Following FDA Removal Of Hold On PEGPH20

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Shares of Halozyme Therapeutics (NASDAQ: HALO) at one point spiked more than 20 percent following the U.S. Food and Drug Administration (FDA) removal of the clinical hold on PEGPH20.

A Revised Protocol for PEGPH20

In a press release on Wednesday, Halozyme announced FDA's removal of the “clinical hold on patient enrollment and dosing of PEGPH20 in the ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer permitting the study to resume under a revised protocol.”

Halozyme President and CEO, Dr. Helen Torley, said, “We are committed to the development of PEGPH20 in pancreatic cancer. Halozyme worked diligently with the FDA and the DMC to develop the plan to allow the study to restart. We are pleased to be able to continue enrolling patients in this clinical program as there remains a significant need for new treatment options for pancreatic cancer patients.”

The amendments to the protocol “include the exclusion of patients who may be at higher risk of thromboembolic events. Additionally, low-molecular weight heparin will be used as a prophylaxis to prevent thromboembolic events. In addition to the over 100 patients already enrolled in the trial, Halozyme plans to enroll a similar number of additional patients.”

Details on PEGPH20 and Study 202

PEGPH20 is a PEGylated form of “Halozyme's proprietary recombinant human hyaluronidase under development for the systemic treatment of tumors that accumulate hyaluronan.”

Study 202 is the Phase 2 clinical trial to study PEGPH20 as a therapy to treat patients with stage IV metastatic pancreatic cancer. The trial will measure the improvement and survival in patients receiving PEGPH20 in combination with gemcitabine and nab-paclitaxel compared with patients just receiving gemcitabine and nab-paclitaxel.

Secondary endpoints of Study 202 “include objective response rate and overall survival.”

Halozyme shares are trading around $9.27, up 14.7 percent.

Posted-In: Removal of Clinical Hold on PEGPH20News FDA Management


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