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Saturday, December 11, 2021 11:43:07 AM
https://nwbio.com/northwest-biotherapeutics-announces-data-lock-of-phase-iii-trial/
05
OCT
2020
Northwest Biotherapeutics Announces Data Lock of Phase III Trial
FOR IMMEDIATE RELEASE
CONTACTS
Dave Innes
804-513-4758
dinnes@nwbio.com
Les Goldman
240-234-0059
lgoldman@nwbio.com
BETHESDA, Md., October 5, 2020 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that the database for the Phase III trial of DCVax®-L for Gliobastoma has been locked.
With the database now locked, the independent service firms managing the Clinical Trial are arranging for the independent statisticians to have access to the unblinded raw data from the Trial. Neither the Company nor any party other than the independent statisticians will have access to any unblinded data at this stage.
The statisticians will proceed as quickly as possible with analyses of the raw data and prepare summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, who will analyze the data with the statisticians in preparation for public announcement and scientific publication.
“We are excited to be so close to the finish line now, after such a long road” commented Linda Powers, the Company’s CEO. “We are hopeful that DCVax®-L can become an important new treatment option for patients who urgently need more and better treatments for Glioblastoma brain cancer.”
“We are grateful to the independent service firms and the clinical trial sites who have worked so hard to complete the data collection and confirmation during many months of COVID restrictions and challenges,” Ms. Powers continued. “We are also very grateful to our shareholders for their patience and support, which has made all this possible.”
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 North America 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 of DCVax®-L for 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 development of DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial, and is preparing for Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
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