NW Bio Announces Completion of Further Data Gathering For Phase III Trial
Northwest Biotherapeutics (OTCQB: NWBO) has completed outstanding clinical trial data for its Phase 3 trial of DCVax®-L for Glioblastoma brain cancer. The data includes genomic profiling for IDH mutations and imaging, which is now being integrated into the trial database. Following Data Lock, independent statisticians will access the unblinded dataset to analyze and report results. Topline data is anticipated in September 2020, with updates as the process progresses. The trial involves 331 patients and aims to provide a personalized treatment for this aggressive cancer.
- Completion of outstanding clinical trial data for Phase 3 trial of DCVax®-L.
- Inclusion of genomic profiling and imaging data into the trial database.
- Upcoming topline data expected in September 2020.
- Data Lock and final results depend on the timely performance of independent statisticians.
- Risks related to uncertainties in clinical trials and potential delays in reporting outcomes.
BETHESDA, Md., Aug. 19, 2020 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO)("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that the remaining outstanding clinical trial data for the Company's Phase 3 trial of DCVax®-L for Glioblastoma brain cancer as described in the Company's last report on July 24, 2020 has now been completed by the specialty analytics firms. With this data now in hand, final quality control checking and confirmation are under way to enable Data Lock.
This further data involves specialty analytics such as genomic profiling for IDH mutations and certain imaging. The independent CRO managing the trial is now integrating this data into the overall trial database containing the clinical data from the trial sites that was already complete and locked as reported on July 24, 2020, in order to complete the overall trial dataset.
When Data Lock is reached, the independent statisticians will be given access to the unblinded dataset. The Company will remain blinded while the statisticians make the computations, converting the mass of raw data from the trial into formal tables and listings, and survival and progression measures, to report the trial results.
As previously reported, the statisticians' work is estimated to take a couple of weeks. When their computations are completed, the Company will receive the results of those computations and thereby become unblinded. It is anticipated that the Company's Scientific Advisory Board, the Steering Committee of the Trial and other key medical expert advisors will likewise receive the results, and thereby become unblinded as well.
The Company currently continues to anticipate reporting topline trial data in September, and anticipates providing further updates as the process progresses.
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 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.
Disclaimer
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "design," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We cannot guarantee that we actually will achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company's ability to enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the timely performance of third parties, risks related to whether the Company's products will demonstrate safety and efficacy, risks related to the Company's ongoing ability to raise additional capital, and other risks included in the Company's Securities and Exchange Commission ("SEC") filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company's results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company's SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
CONTACTS | |
Dave Innes | Les Goldman |
804-513-4758 dinnes@nwbio.com | 240-234-0059 lgoldman@nwbio.com |
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SOURCE Northwest Biotherapeutics
FAQ
What is the status of NWBO's Phase 3 trial for DCVax®-L?
What data has been included in NWBO's trial for Glioblastoma?
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What does Data Lock mean for NWBO's trial?
