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NW Bio Announces Lifting of Clinical Hold on

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TC_Trader   Monday, 02/06/17 09:31:37 AM
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NW Bio Announces Lifting of Clinical Hold on DCVax®-L Phase III Trial By FDA; Progression-Free Survival Events Reached; Overall Survival Events Not Yet Reached 2017-02-06 14:30:03.874 GMT

Process Now Moving Forward Toward Data Lock

PR Newswire

BETHESDA, Md., Feb. 6, 2017

BETHESDA, Md., Feb. 6, 2017 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB:
NWBO) ("NW Bio" or the "Company"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today provided a further update about the Company's Phase III trial of DCVax®-L for Glioblastoma multiforme ("GBM") brain cancer (the "Trial"). 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.

There are 331 patients enrolled in the Trial. The Trial endpoints involve thresholds of 248 "events" for PFS and 233 "events" for OS. PFS events are primarily tumor progression (i.e., recurrence), although they can occasionally be patient deaths which occur without prior evidence of tumor recurrence. OS events are patient deaths. The PFS and OS events are continuing to accumulate as the Trial continues. The PFS events have surpassed the 248-event threshold, but the OS events have not yet reached the 233-event threshold. Based upon the pace of OS events during the last six to eight months, the Company's current anticipation is that it will be several months until the Trial reaches 233 OS events.

Dr. Linda Liau, Principal Investigator of the DCVax®-L Trial commented: "It is gratifying to have the hold removed from the Trial and exciting to see this Trial now moving towards completion, although of course the longer it takes for PFS and OS events to accrue, the better the patients in the Trial are doing."

The external parties managing the Trial are now moving forward with the process to reach data lock. In this process, all data from all of the treatment visits and follow up visits for all 331 patients in the Trial, must be subjected to quality control checking. The process involves in-person monitoring visits to all of the 80-plus sites in four countries to review the files onsite, as well as other documentary confirmation and checking of all MRI images. As such, it is a multi-month process. While this process is under way, OS and PFS events will continue to accumulate.

The Trial will reach data lock when the threshold events have been reached and the quality control checking has been completed for both the PFS and OS endpoints.

When data lock is reached, external statisticians and experts will make an independent analysis of the Trial data. The Company will remain blinded until data lock has been reached and the external data analysis has been completed.

About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed 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 331-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease." The Company is also pursuing a Phase I/II trial with DCVax-Direct for all types of inoperable solid tumor cancers. It has completed the 40-patient Phase I portion of the trial, and is preparing for the Phase II portion. The Company previously conducted a Phase I/II trial with DCVax-L for metastatic ovarian cancer together with the University of Pennsylvania.




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