NW Bio To Discuss Projected Schedule For Data Lock, Unblinding and Top Line Data From Its Phase 3 Clinical Trial At Annual Shareholder Meeting
BETHESDA, Md., April 18, 2020 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that its CEO, Linda Powers, will discuss the projected schedule for reaching data lock, unblinding and reporting of top line data from its 331-patient Phase 3 trial of DCVax®-L for Glioblastoma brain cancer at the Company’s 2019 Annual Meeting. The Meeting is being held virtually due to the current public health crisis.
The Company has been working since last year with the contract research organization (CRO) that managed the trial and numerous independent service companies to make the final in-person monitoring visits to all the clinical trial sites (hospitals) across the US and Europe, and to finish collecting and confirming the Phase 3 trial data and resolving queries.
Despite nearly two months (during March and April to date) in which hospital trial sites stopped allowing in-person data monitoring visits and became too overwhelmed to continue helping with data confirmation, the Company’s data collection and confirmation process has continued moving forward in part through workarounds.
The data collection process is including certain epigenetic and genetic information that is recognized as important in Glioblastoma, such as MGMT methylation status. As part of this process, the Company has also identified a method that can potentially enable an additional important genetic factor — IDH mutation status — to be analyzed using bio samples collected years ago during the trial, and to be analyzed in the same timeframe as the data lock. This IDH mutation factor was unknown when the Company’s trial began and through much of the trial period, but has become recognized as very important in recent years.
After factoring in the March and April shutdowns, and the additional genetic analysis, the Company believes it can reach data lock by approximately the end of May.
Upon reaching data lock, the data will be unblinded to the independent statisticians (i.e., the statisticians will be given access to the trial database containing all of the raw data points). The Company will not yet become unblinded at this time.
The independent statisticians will then use the raw data to calculate the relevant measures, such as median survival times and survival percentages at various time points. The statisticians will also calculate various statistical measures and prepare graphs and tables. This work is anticipated to take several weeks. The Company will become unblinded when it receives these results from the statisticians.
The Company will then discuss the information from the statisticians with its expert advisors, including its Scientific Advisory Board and the Steering Committee of the Phase 3 trial. Any questions or comments raised by the experts will be addressed and the results will be prepared for public announcement.
Based on these expectations, and taking account of the two months lost in March and April, the current estimate of public disclosure of top line data would range from the end of June to early July.