First Interim Analysis Of NW Bio’s Phase III GBM Trial Triggered By Reaching Required Number Of “Events”
Analysis Process Under Way For Data Monitoring Committee’s Assessment
BETHESDA, MD, December 10, 2013 – 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.
“We are very pleased to reach this significant milestone in our Phase III GBM trial in accordance with our projections, reflecting our steady progress as we work towards completing this important trial” commented Linda F. Powers, CEO of NW Bio. “We are grateful to all the clinical trial sites and all the patients who have helped reach this milestone, and we look forward to ramping up the trial as a growing number of European sites open.”
About Northwest Biotherapeutics
Northwest Biotherapeutics is developing cancer vaccines designed to treat a broad range of solid tumor cancers more effectively than current treatments, and without the side effects of chemotherapy drugs. NW Bio’s proprietary manufacturing technology enables the Company to produce its personalized vaccine in an efficient, cost-effective manner. The Company has a broad platform technology for DCVax dendritic cell-based vaccines. The Company’s lead product, DCVax-L, is currently in a 312-patient Phase III trial for patients with newly diagnosed Glioblastoma multiforme (GBM), the most aggressive and lethal brain cancer. The Company’s second product, DCVax-Direct, is currently in a 60-patient Phase I/II trial for direct injection into all types of inoperable solid tumor cancers. The Company has also conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania. The Company previously received clearance from the FDA for a 612-patient Phase III trial with its third product, DCVax-Prostate, for late stage prostate cancer.
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,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify 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 the Company’s ability to raise additional capital, risks related to the Company’s ability to enroll patient s in its clinical trials and complete the trials on a timely basis, the uncertainty of the clinical trials process, uncertainties about the timely performance of third parties, and whether the Company’s products will demonstrate safety and efficacy. Additional information on these and other factors, including Risk Factors, which could affect the Company’s results, is included in its Securities and Exchange Commission (“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. You should not place undue reliance on any forward-looking statements. 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.