United States

FDA grants Priority Review for Lilly’s Olaratumab

Monday, May 9, 2016

The FDA has granted Priority Review for the biologics license application (BLA) for Eli Lilly’s olaratumab, a PDGFRα antagonist, in combination with doxorubicin, for the potential treatment of people with advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery.

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Inovio, NIH, Mayo to initiate hepatitis C immunotherapy trial

Thursday, April 28, 2016

Inovio Pharmaceuticals has announced that its immunotherapy for hepatitis C (INO-8000) will be evaluated in a phase I trial in chronically infected patients who are not receiving other hepatitis C virus (HCV) treatments. The study will enroll patients who are in the early stages of chronic HCV infection to determine the therapy’s ability to decrease and potentially eliminate HCV viral load, measure HCV specific immune responses and durability of these immune responses, and evaluate safety and tolerability. In this dose-escalation study INO-8000 will be combined with increasing doses of DNA-based IL-12 (INO-9012), an immune activator, which in previous studies has been shown to increase the therapeutic immune response to DNA immunotherapies.

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