Halozyme To Resume Trial In Pancreatic Cancer Drug; Stock Up - Update

(RTTNews) - Shares of Halozyme Therapeutics Inc (HALO) surged 13 percent in extended-hours trade on Wednesday after the biopharmaceutical company said it will resume clinical trial of its investigational pancreatic cancer drug PEGPH20.

This follows the U.S. Food and Drug Administration's removal of the clinical hold on patient enrollment and dosing of PEGPH20 in the ongoing Phase 2 trial in pancreatic cancer. The Agency permitted the study to resume under a revised protocol.

Halozyme said patient enrollment is anticipated to recommence upon review and approval of the amended protocol by the Independent Review Boards at the participating clinical trial sites. In May, the trial's independent Data Monitoring Committee recommended that enrollment and dosing in the study resume under a revised protocol.

"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," said CEO Helen Torley.

Study 202 (Halo 109-202) is a Phase 2 randomized trial evaluating PEGPH20 as a first-line therapy for treatment of patients with stage IV 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 has been added to assess the thromboembolic event rate in the PEGPH20 treatment arm following the protocol amendment. In addition to the over 100 patients already enrolled in the trial, Halozyme plans to enroll a similar number of additional patients.

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

Halozyme stock closed Wednesday at $8.08, up $0.19 or 2.41%, on a volume of 680k shares. In after hours, the stock gained $1.08 or 13.37%, to trade at $9.16.