Halozyme announces that rrial of Hylenex recombinant met primary endpoint Halozyme announced that the primary endpoint of non-inferiority of A1C levels at six months was met for the CONSISTENT 1 trial. The trial is evaluating Hylenex recombinant and a new formulation of Hylenex currently under FDA review, when used as pretreatment of the insulin infusion site in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion in comparison to no pre-treatment. In accordance with the trial protocol pre-specified analysis of the endpoints, data from the two patient groups treated with Hylenex formulations were pooled in comparison to a group consisting of patients using standard CSII with rapid acting analog insulin alone. Adverse events were similar across the treatment and control groups. The most common treatment related adverse event in the Hylenex groups was mild infusion site discomfort.
Halozyme's pancreatic cancer candidate clinical trial approved by FDA to resume Halozyme announced that the FDA has removed the clinical hold on patient enrollment and dosing of PEGPH20 in SWOG's ongoing Phase 1b/2 clinical trial. The trial is designed to evaluate Halozyme's investigational drug PEGPH20 in combination with modified FOLFIRINOX chemotherapy in patients with metastatic pancreatic adenocarcinoma. The study will resume under a revised protocol.