"We are excited to receive this rapid final approval of our Phase III GBM trial from the German regulator," commented Linda Powers, CEO of NW Bio. "DCVax®-L is now one of the first active immune therapies to reach approval for Phase III trials by multiple major regulatory authorities. DCVax®-L is also now one of the first Advanced Therapy Medicinal Products (the legal classification covering all types of cell therapies in Europe) to reach Phase III clinical trials. We are now beginning the final phase of this important international Phase III trial, with enrollment in both Europe and the US occurring in parallel, potentially finishing enrollment by the late summer of next year, and potentially reaching top line results by the end of next year."
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both the United States and Europe. The Company has a broad platform technology for DCVax dendritic cell-based vaccines. The Company's lead program is a 312-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer. The Company is also under way with a 60-patient Phase I/II trial with DCVax-Direct for all inoperable solid tumors cancers, with a primary efficacy endpoint of tumor regression, and some results expected before year end.. The Company also previously received clearance from the FDA for a 612-patient Phase III trial in prostate c
|SOURCE Northwest Biotherapeutics|
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