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June 20, 2014
08:27 EDTNWBONorthwest Biotherapeutics reaffirms DCVax-Direct clinical trial interim data
Northwest Biotherapeutics announced that it refuted Adam Feuerstein's "latest false headline and attack on the company", reaffirming the company's recent interim data announcements from its Phase I/II clinical trial of DCVax-Direct for all inoperable solid tumors. The company added, "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.
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July 17, 2014
11:12 EDTNWBOOptions with decreasing implied volatility
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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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