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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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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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