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halozyme therapeutics inc (HALO) Key Developments

Halozyme Therapeutics, Inc. Resumes Patient Enrollment and Dosing In PEGPH20 Clinical Program in Pancreatic Cancer

Halozyme Therapeutics, Inc. 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. 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.

Halozyme Therapeutics, Inc. to Resume PEGPH20 Clinical Program in Pancreatic Cancer

Halozyme Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has removed 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. 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 (DMC) recommended that enrollment and dosing in the study resume under a revised protocol. 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 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. Secondary endpoints include objective response rate and overall survival. The protocol amendments to the study 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. 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 Therapeutics, Inc. Presents at Jefferies 2014 Global Healthcare Conference, Jun-05-2014 12:30 PM

Halozyme Therapeutics, Inc. Presents at Jefferies 2014 Global Healthcare Conference, Jun-05-2014 12:30 PM. Venue: Grand Hyatt, New York, New York, United States. Speakers: Helen I. Torley, Chief Executive Officer, President and Director.

Baxter Provides U.S. Regulatory Update on HyQvia

Baxter International Inc. and Halozyme Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application (BLA) for HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], the company's investigational subcutaneous treatment for patients with primary immunodeficiency (PI). The FDA is requiring additional time to review supplemental data that Baxter provided as part of the ongoing BLA process for HyQvia approval. The PDUFA date has been extended by three months, which is the standard extension period. As part of the FDA's extended review of the HyQvia BLA amendment, Baxter now expects to participate in a Blood Products Advisory Committee (BPAC) meeting, which the agency has scheduled for July 31, 2014. HyQvia was approved by the European Commission for EU member states in 2013 and is available in several European countries, including Germany, Netherlands, Sweden, Norway, Denmark, Ireland and Italy.

Halozyme Therapeutics, Inc. Presents at JMP Securities Healthcare Conference, Jun-24-2014 02:30 PM

Halozyme Therapeutics, Inc. Presents at JMP Securities Healthcare Conference, Jun-24-2014 02:30 PM. Venue: The Westin New York Grand Central, 212 East 42nd Street, New York, NY 10017, United States. Speakers: David A. Ramsay, Chief Financial Officer, Principal Accounting Officer and Vice President.

 

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