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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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