BETHESDA, Md., June 20, 2014 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today refuted Adam Feuerstein's latest false headline and attack on the Company, and reaffirmed the Company's recent interim data announcements from its Phase I/II clinical trial of DCVax-Direct for all inoperable solid tumors.
The Company's DCVax-Direct trial is ongoing. Contrary to Feuerstein's sensationalized false headline, the Company has not received a "rebuke" from any clinical trial site, nor does the Company believe there is any basis for any such "rebuke."
The Company has consistently said that it would release interim data on an ongoing basis during the course of its DCVax-Direct Phase I/II trial. This trial is a single-arm, unblinded, "open label" trial, meaning that all of the patients in the trial are receiving the DCVax-Direct treatment, and the clinical results in patients are visible to the Company as the trial goes along.
There has been significant interest in this trial, and the Company has been receiving many requests for data updates, as this trial is testing a novel treatment for patients with late stage, inoperable tumors patients for whom there are virtually no treatment options today. The data released by the Company came from the medical files at the clinical trial sites and reviews of imaging and biopsies, and was provided by the sites and pathology labs, as well as a respected and independent clinical research organization (CRO) managing the trial.
Contrary to Feuerstein's assertions of promotional claims by the Company, in fact the Company has taken extra care to emphasize in its announcements that the data being reported are only early, initial and partial results. The Company has expressly explained in each announcement that the patients are only part way through the treatment regimen, and the Company specifically cautioned that the data could get either better or worse as more data are collected.
Also contrary to Feuerstein's attack, it is neither unusual nor inappropriate for interim results from unblinded, open label trials to be reported, particularly in the case of a novel technology in a particularly difficult disease setting that is the subject of significant scientific, clinical and public interest. In such cases, both companies and researchers frequently provide interim data and/or case studies.
Linda Powers, CEO of NW Bio, commented: "As NW Bio continues to make strong progress in multiple programs with two product lines, for both operable and inoperable tumors, and as NW Bio's clinical programs show encouraging early effects, Feuerstein seeks ever more sensationalized ways to try to smear the Company. This is not even the semblance of professional analysis. We condemn this attack campaign and appreciate the strong support we are receiving from shareholders, patients and other commentators. We intend to continue our progress undeterred."
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 312-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. 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 the Company's ongoing ability to raise additional capital, 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 and Cognate's abilities to carry out the intended manufacturing expansions contemplated in the Cognate Agreements, 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.
Logo - http://photos.prnewswire.com/prnh/20110329/SF73084LOGO
SOURCE Northwest Biotherapeutics, Inc.