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News Breaks
July 16, 2014
08:20 EDTNWBONorthwest Biotherapeutics completes DCVax-Direct Phase 1 trial recruitment
Northwest Biotherapeutics announced that the Phase I portion of the company's Phase I/II DCVax-Direct clinical trial has completed its 36-patient target recruitment, and the company is now underway with preparations for the Phase II portion of this trial, as well as expansion of DCVax-Direct manufacturing. The Phase I/II trial is testing the safety and activity of DCVax-Direct in various types of cancer. The Phase I portion of the trial has involved testing of 3 different dose levels, and a diverse range of cancers. The patients enrolled in Phase I will continue to receive treatments in accordance with the protocol. With the closing of Phase I, the company is now preparing to initiate the Phase II portion of the trial. This second part of the Phase I/II study will target 24 or more patients in selected cancers. Additional trial sites are being brought on to facilitate and expedite enrollment. The company and its manufacturing partner, Cognate BioServices, are also expanding the manufacturing capacity for DCVax-Direct.
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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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