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News Breaks
May 15, 2014
08:12 EDTNWBONorthwest Biotherapeutics reports initial positive data in cancer candidate tria
Northwest Biotherapeutics provided an initial patient case study, showing signs of tumor necrosis or death and initial tumor regression, from the company's ongoing DCVax-Direct trial for all types of inoperable solid tumors. The company continues collecting data from the trial. The specific case study involves a sarcoma patient with a large tumor mass and multiple inoperable metastatic tumors in the lung. This patient's results suggest both local and systemic effects of the DCVax-Direct treatment, as were seen in the pre-clinical studies. These results were further supported by tumor biopsies taken at the time of the most recent injection, which showed a high rate of tumor necrosis and appearance of T cells infiltrating into the injected tumor. The company is currently conducting a 60-patient Phase I/II trial with DCVax-Direct for all types of inoperable solid tumors.
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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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