NW Bio Provides Update About Phase 3 Trial Of DCVax®-L for Newly Diagnosed Glioblastoma Multiforme Brain Cancer
Very exciting news. Nobody knows why the trial was placed on hold. Usually that is a bad sign but there are many reasons a trial can be placed on hold that have nothing to do with how good a treatment is. See www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm . I doubt it is for safety reasons, as there were no safety issues at all in the first few trials and in similar trials. That is the one we would worry about if it were true. There are many other reasons. One possibility is that the FDA thinks that the trial will not prove anything. There has been arguments back and forth about appropriate endpoints. At one time the FDA allowed progression free survival as an endpoint, but then the Avastin trial showed excellent progression free survival but no increase in overall survival, so the FDA changed its stance and said it wanted overall survival as an endpoint and that progression free survival is not enough. This happened after the trial was designed. The primary endpoint is progression free survival. This trial allows patients in the control group to cross over and get the vaccine when they have a recurrence. This messes up the endpoint of overall survival because you will be comparing people who get the vaccine to people who get the vaccine. The FDA may think it is futile to try with the current design and may want the trial redesigned and done over again, which would probably be too expensive and lead to abandoning of the treatment. I would protest that it is unethical to not allow cross over for the control group. (Let alone that it is unethical to have a control group in the first place).
Anyway - this press release says they have stopped enrollment in the trial and will just analyze the results they have. They already enrolled 331 patients, which should be enough to tell how it looks. IF it shows a progression free survival benefit, we will be fighting to get it approved based on this trial and hopefully not have to go through another phase 3 trial.
Posted on: 12/09/2016
BETHESDA, Md., Dec. 8, 2016 /PRNewswire/ -- Northwest Biotherapeutics (Nasdaq: NWBO) ("NW Bio" or the "Company"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today provided an update about the Company's Phase 3 trial of DCVax®-L for Glioblastome multiforme (GBM) brain cancer (the "Trial"). The Company announced that 331 of the planned 348 patients have been enrolled in the Trial, and that data "events" have been accumulating towards the endpoints of the Trial.
As noted in the profile of the Trial on www.clinicaltrials.gov, the Company had estimated that the numbers of "events" to reach the main endpoints of the Trial may be reached in November 2016. Following the end of the month last week, the Company requested updates from the external parties managing the Trial about the numbers of "events" (i.e., tumor recurrences or deaths). Such updates typically take a couple of weeks, including quality control checking. The Company hopes to receive this information and be able to make a further update announcement in approximately the next two weeks. The Company remains blinded in regard to the Trial data and, as before, will only be receiving such updates on a blinded basis.
Since the summer of last year, the trial has been subject to a partial clinical hold, only on recruitment. As a result of the partial hold, the Trial has not enrolled the last 17 of the total 348 patients. To date, the regulators have not agreed to remove the partial hold, but have allowed all of the patients in the Trial to continue being treated in accordance with the Protocol. The Company is pursuing ongoing dialog with regulators. However, at this point the Company believes that the potential benefits that could be obtained from enrolling the final 17 patients would not be worth the time it would take, as the process of re-starting and re-training the sites (including through Institutional Review Board renewals) for further enrollment would take months, followed by further months for the recruitment itself.
Accordingly, the Company is no longer seeking to enroll the last 17 of the 348 patients. Rather, the Company is focused on accumulation of the "events" necessary for the Trial endpoints. When sufficient "events" have accumulated, the external parties managing the Trial will then begin the process of moving toward "data lock" and then analysis of the data, which are typically each multi-month processes, particularly for large international trials.
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 United States and Europe. The Company has a broad platform technology for DCVax dendritic cell-based vaccines. The Company's lead program is a 348-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM), which is on a partial clinical hold in regard to new screening of patients. GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease." The Company is under way with a Phase I/II trial with DCVax-Direct for all types of inoperable solid tumor cancers. It has completed enrollment in the 40-patient Phase I portion of the trial. The Company previously conducted a Phase I/II trial with DCVax-L for metastatic ovarian cancer together with the University of Pennsylvania.
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. 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 ongoing ability to raise the necessary funding for its clinical programs, risks related to the Company's ability to retain the patients in its clinical trials and complete the trials on a timely basis, risks related to clinical trial data collection, completeness and quality control, risks related to the partial clinical hold on the Company's Phase 3 trial, risks related to the clinical trials process, risks related to the timely and effective performance of third parties, including with respect to data collection, security and analysis, risks related to whether the Company's products will demonstrate safety and efficacy, risks related to regulatory review and/or acceptance of clinical trial data, risks related to the Company's ability to carry out the Hospital Exemption program and risks related to possible reimbursement and pricing. 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.
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SOURCE Northwest Biotherapeutics
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