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SOURCE Northwest Biotherapeutics, Inc.
Phase III Trial Is Alive And Well; "Hint Of Failure" A Complete Fabrication; No Interim Analysis of Efficacy Done; 55 Patients' Positive Data Independently Collected.
BETHESDA, Md., Aug. 13, 2014 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today corrected ongoing false claims by Adam Feuerstein published on the TheStreet.com about the Company's Phase III trial of DCVax-L for Glioblastoma multiforme (GBM) brain cancer:
The Company confirmed, yet again, that no interim analysis of efficacy relating to the Phase III trial has been conducted at any time. The only analyses to date have been analyses solely about safety (not efficacy), and those safety analyses have been conducted solely by the independent Data Monitoring Committee (DMC), with no involvement of the Company and no communication by the DMC to the Company except to direct that the trial should continue. The Company has had no access to any information about either safety or efficacy in the trial at any time.
"As the Company has stated clearly and specifically in its public announcements, the DMC has not conducted any efficacy analyses and the DMC has not provided any access for the Company to any clinical trial data," commented Dr. Curt Furberg, Chairman of the DMC. "The DMC adheres to established clinical trial monitoring procedures and does not release any data while the trial is ongoing. This is an important issue, and it is surprising and troubling to see inaccurate claims being made by commentators who seem to lack a fundamental understanding of clinical trial monitoring. I have been on the DMCs for more than 60 clinical trials, and I have never experienced this type of attack."
Since the Company has had no access to any data about the trial at any time, it was impossible for the Company to have been motivated or shaped by any such information or any "hint of failure" about the trial in seeking regulatory approvals for the enhancements of the trial announced on Monday. Feuerstein's assertion of such "hint of failure" lacks any basis and is a total fabrication.
The fact that the Company has had no access to any trial information was also a key factor in obtaining approval from the regulatory authorities in the US, UK and Germany for the enhancements to the trial. Regulatory authorities do not allow changes to be made in an ongoing randomized, blinded trial if the changes are, or might be, based upon any knowledge about clinical data in the trial.
"The fact that there has been no interim analysis for efficacy and that the Company has had no access to trial data, is very clear and very simple," commented Linda Powers, CEO of NW Bio. "There is no room for any honest confusion. Feuerstein's ongoing false claims about these points are either deliberate falsehoods or reckless disregard of the truth."
The Company reiterated that its Phase III trial was already solidly designed prior to the enhancements just announced, with a conservative assumption that the extension of Progression Free Survival (PFS) in patients treated with DCVax-L in the Phase III trial would be only 1/3 as long as the extension of PFS (compared to PFS with standard of care) that was seen in patients treated with DCVax-L in the Phase I/II trials. This conservative assumption in the Phase III trial design was and is also combined with strong statistical powering in the trial design (with an anticipated "p value" of 0.02).
The enhancements of the Phase III trial do not in any way seek to "rescue" a trial that is already strong and solidly designed. The changes seek to prevent external variables from potentially distorting the results of the trial, while also having the added benefit of further lowering the threshold for the primary endpoint to be met from 6 months' difference in PFS to 4 months' difference in PFS between patients treated with DCVax-L and the control arm. This is a further de-risking of the trial, and as such is a valuable enhancement.
The Company also reaffirmed the encouraging survival data in 55 compassionate use "Information Arm" patients that was released by the Company. All of the data was collected and maintained by an independent contract research organization (CRO), not the Company. The Company reported clearly that the data were gathered in a compassionate use "Information Arm" outside the Phase III clinical trial. The Company simply reported the factual results gathered by the independent CRO. Even Feuerstein acknowledges that the data are strikingly positive.
Feuerstein's questions about why those 55 patients were handled separately from the Phase III trial are once again baseless and reflect a lack of understanding of clinical trial design. As the Company explained in its announcement, it is well established in the medical and research communities that "rapid progressor" GBM brain cancer patients have a significantly different version of the disease than regular GBM patients. It is fundamental to clinical trial design that the patients included in a trial must be as homogeneous as possible, in order for the data to be as comparable as possible among the patients in the trial. The Company has followed these fundamental principles in its Phase III trial design.
The Company re-confirmed that the Phase III trial has, in fact, expanded to multiple sites in the UK and Germany as the Company has previously stated. Feuerstein's false claim that "none of the European sites have materialized" is directly contradicted by the Phase III trial profile on www.clinicaltrials.gov that he himself cites. At the bottom of the trial profile there, both the first UK site and the first German site in operation are clearly listed. The listed UK site has been in operation for well over a year. The listed German site was the first among several German sites to which the trial has expanded.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products 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). GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease." The Company is under way with a 60-patient Phase I/II trial with DCVax-Direct for all inoperable solid tumor cancers, and has completed enrollment in the Phase I portion of the trial. The Company previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer. The Company conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania. In Germany, the Company recently received approval of a 5-year Hospital Exemption for treatment of glioma (brain cancer) patients outside the clinical trial.
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 regulatory review and approvals of the Company's clinical trials, 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, risks related to the Company's and Cognate's abilities to carry out the intended manufacturing expansions, 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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