Halozyme Therapeutics, Inc (HALO) announced that the FDA has lifted the clinical hold from a phase Ib/II study (Study S1313). The study is evaluating PEGPH20 (PEGylated recombinant human hyaluronidase) in combination with a modified FOLFIRINOX chemotherapy (mFOLFIRINOX) in patients suffering from metastatic pancreatic adenocarcinoma.

The Study S1313, which is being sponsored and conducted by SWOG (a cancer research cooperative group funded primarily by the National Cancer Institute), commenced in Oct 2013. However, the FDA had placed a clinical hold on the study pending discussions regarding the revision of the protocol to address the risk of thromboembolic events.

SWOG will resume the study under a revised protocol. Subsequently, the study will resume patient enrollment once the Independent Review Boards at different study sites review and approve the amended protocol. SWOG intends to enroll nearly 170 patients in the study.

Biotech Stock News

We remind investors that in June this year, the FDA had removed the clinical hold from a phase II study (Study 202) on PEGPH20 (first-line therapy for patients with stage IV metastatic pancreatic cancer). Following the removal of the clinical hold, Halozyme resumed patient enrollment and dosing of PEGPH20 in July this year.

Earlier this week, more good news came Halozyme’s way when the FDA approved HyQvia (for the subcutaneous treatment of adult patients with primary immunodeficiency). HyQvia has been jointly developed by Halozyme and Baxter International.

Biotech Financial News

The lifting of the clinical hold on Study 202 and Study S1313 by the FDA is a major positive for Halozyme. We expect investor focus to remain on further updates on the status of the PEGPH20 program.

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