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News Breaks
May 29, 2014
09:34 EDTNWBONorthwest Biotherapeutics refutes claims by Adam Feuerstein
Northwest Biotherapeutics refuted the statements made by Adam Feuerstein in an article on Tuesday, May 27. Regarding Feuerstein's headline, "Cancer Patients Aren't Responding to Northwest Bio's DCVax-Direct" and the claim that "None of the 19 patients with advanced, metastatic cancers have responded to treatment with DCVax-Direct in an ongoing Phase I clinical trial", Northwest stated that "While still only part way through treatment, more than 50% of these patients - 11 of the 19 - have already shown tumor shrinkage of up to 28%, substantial tumor cell death and substantial accumulation of immune cells in the tumors." Regarding Feuerstein's claim that "Under the globally accepted definition of tumor response known as RECIST, a partial response requires a 30% reduction in the size of the target lesion. DCVax-Direct: 0% response rate", Northwest stated that "There are numerous types of established measures of patient responses to treatments. The measures reported in the company's announcement are considered clinically significant and are regularly the focus of peer reviewed scientific and medical publications in oncology, particularly for late stage disease. Further, the RECIST criteria themselves include multiple categories."
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August 21, 2015
15:26 EDTNWBONorthwest Biotherapeutics confirms Phase 3 trial of DCVax-L is ongoing
Northwest Biotherapeutics confirmed that its Phase III trial of DCVax-L for newly diagnosed glioblastoma multiforme is ongoing and the patients enrolled in the trial are continuing to be treated per the protocol. Over 300 patients have been recruited for the trial. The total anticipated enrollment is 348 patients. The only change in status of the trial is that new screening of patient candidates for the trial has been temporarily suspended while the company submits certain information from the trial for regulatory review. Such screening involves the initial evaluation of patient candidates to determine whether they meet eligibility criteria for the trial. Some blogs and social media comments have noted that the EudraCT trials database in Europe states that there is a "Temporary Halt" of the trial in Germany. In actuality, the trial status in Germany is that the trial is ongoing as noted above, and the company has only undertaken a temporary suspension of new screening. The company has sought to have the EudraCT listing corrected, but the database includes only certain pre-specified categories and there is no category that corresponds to a temporary suspension of new screening only, while a trial is ongoing. The company is in the process of preparing the trial information for regulatory review and anticipates submission within the next couple of weeks.
12:49 EDTNWBONorthwest Bio stops screening new patients in DCVax-L study, Reuters reports
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09:13 EDTNWBOOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Accuray (ARAY), up 12.7%... Brocade (BRCD), up 6%... salesforce.com (CRM), up 3.5%. DOWN AFTER EARNINGS: Intuit (INTU), down 6.7%... Deere (DE), down 5.4%... Nordson (NDSN), down 4.4%. ALSO LOWER: GigOptix (GIG), down 20% after 9.22M share Spot Secondary priced at $1.70... VirnetX Holding (VHC), down 19.8% after filing to sell 35M shares of common stock... Northwest Biotherapeutics (NWBO), down 8.7% after TheStreet's Adam Feuerstein reports, via Twitter, that CVax Phase 3 study has been temporarily halted in Germany.
08:49 EDTNWBONorthwest Phase 3 study halted in Germany TheStreet's Feuerstein says
The European Union Clinical Trials Register says Northwest Biotherapeutics' DCVax Phase 3 study has been "temporarily halted" in Germany, TheStreet's Adam Feuerstein reports via Twitter. Shares of Northwest are down 63c to $8.25 in pre-market trading.

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