FDA lifts partial hold on phase III trial of DCVax-L (gene therapy) for Glioblastoma multiforme brain cancer- Northwest Biotherapeutics

Northwest Biotherapeutics has provided an update about the Company's Phase III trial of DCVax-L (gene therapy) for Glioblastoma multiforme brain cancer. The Company announced that the partial clinical hold on the Trial has been lifted by the FDA, and that the Trial has accumulated a sufficient number of events toward the progression-free survival (PFS) endpoint, but not yet for the overall survival (OS) endpoint. The Company remains blinded to all Trial data, and is only receiving and reporting updates on a blinded basis.

On February 3, the FDA lifted the partial clinical hold which had been in place on the Trial. As previously reported, the Company has been in an ongoing dialog with regulators. The dialog culminated in the FDA lifting the partial hold. As previously announced by the Company, and as the Company also informed the FDA, the Company has closed enrollment and is not going to enroll the last 17 of the planned 348 patients.