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Halozyme Doses First Patient In Phase 3 Clinical Trial Of PEGPH20 In Combination With ABRAXANE And Gemcitabine

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Additional Relevant Details The global, randomized, double-blind, placebo controlled trial will study Halozyme's investigational drug, PEGPH20, in combination with ABRAXANE (nab-paclitaxel) and gemcitabine in patients identified to have tumors that accumulate high levels of hyaluronan (HA). HA is a glycosaminoglycan, or chain of natural sugars that may impede access of drugs targeting the tumor. Halozyme's PEGPH20 temporarily degrades HA and has been shown in animal models to increase the concentration of co-administered therapies in the targeted tumor.Halozyme also announced that the investigational device exemption (IDE) submitted to the FDA last month by Halozyme's partner Ventana Medical Systems has been approved. This IDE allows Halozyme to use the Ventana HA CDx Assay as the companion diagnostic in Halo-301 to prospectively identify HA-High patients for inclusion in the study.
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Catalyst Date
Occurred on:
Mar 16, 2016
Related Keywords Abraxane, Gemcitabine, Pegph20, Phase 3 Clinical Trial, Investigational Device Exemption