Dec. 10, 2013
/PRNewswire/ -- Northwest Biotherapeutics, Inc. (NASDAQ: NWBO) ("NW Bio"), a biotechnology company developing non-toxic DCVax® personalized immune therapies for solid tumor cancers, announced today that the number of events required to trigger the first interim analysis of its Phase III clinical trial in patients with Glioblastoma multiforme (GBM) brain cancer has been reached, and the analysis process is under way which will culminate in the independent Data Monitoring Committee's assessment.
This important milestone is measured by "events," which are defined as either a tumor recurrence or a death. The pre-specified trigger number for this first interim analysis of NW Bio's international Phase III trial is 66 such events, comprising 60% of the 110 events required to reach the primary endpoint of the Phase III trial. Another interim analysis will occur when 88 events, comprising 80% of the total 110 events, have been reached.
As is normally the case, this interim analysis of the Company's Phase III trial data is being conducted by an independent Data Monitoring Committee (DMC), with assistance from the independent CRO (contract research organization) managing the trial. The independent CRO audits and confirms the raw data, and delivers it to the DMC. The DMC then reviews and evaluates the data and reaches an assessment, which it delivers to the Company. The most common DMC recommendation is to continue the trial as originally planned, although it is possible in rare instances that the DMC may recommend that the trial be stopped, either because of safety or futility concerns or because of unexpectedly high levels of success. The Company does not participate in the interim analysis process or the assessment, and both the Company and the clinical trial sites remain completely blinded.
Due to the work involved in auditing and preparing the data, and conducting the review, it is anticipated that the DMC may complete its evaluation and recommendation approximately six to eight weeks from now.