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Replies to post #233377 on NorthWest Biotherapeutics Inc (NWBO)
My initial inclination is to think could it have been then with the original 38 that the imbalance in the 2:1 randomization came from? If there were about 31 treatment in that group of 38, and only 7 who were control, that might account for the disparity.
listen at the 20 minute mark. She indicates that with the first iteration of the trial, the “vanguard group” (she doesn’t call it that, but we have referred to that group of 38 as that), those enrolled from 2007/08 to 2010, had very few placebo patients. LL indicates that when the trial rebooted around 2010, and eventually became a P3 trial, it was at this time forward that the trial was fully randomized. At least that’s how I heard it.
"The Company is clarifying that the 32 patients in the Pseudo-Progressor Arm are in addition to the 331 patients enrolled in the Main Arm of the Trial and are not included in the 331. The Company notes that there are 90 patients in other separate arms of the Trial in addition to the 331 patients in the Main Arm, making a total of 421 patients. The 90 patients include the 32 patients in the Pseudo-Progressor Arm, 55 patients in the Information Arm, and 3 patients who were enrolled at the very beginning of the Trial when it was randomized but not yet blinded. The Trial was blinded after those initial patients were enrolled.
In addition to these 421 patients, the Company has treated a substantial number of patients on a compassionate basis under an Expanded Access Protocol."
In December 2006, we commenced recruiting patients with newly diagnosed GBM in a 141 patient Phase II DCVax ® -Brain clinical trial. We planned to carry out the study at 12 to 15 clinical sites. The study was designed as a randomized study in which patients received either DCVax ® -Brain in addition to standard of care or standard of care alone. To date, almost 50 patients have been screened at 4 clinical sites. However, patients have been reluctant to enroll in the study when faced with a 33% chance of being randomized into the control arm of the study under which they will receive standard of care alone. In order to address this issue we redesigned the study as a randomized, placebo controlled, double blinded study with a cross-over arm allowing control patients to be treated with DCVax ® -Brain in the event that their cancer progresses.
The study size has been increased from 141 to 240 patients and is designed to enable us to petition the FDA for accelerated approval if the study generates results similar to those achieved in earlier Phase I studies. In order to enable rapid enrollment, we are in the process of enrolling 45 to 50 additional clinical sites for this trial. As of April 9, 2008, seven sites are active and a further 31 sites are at various stages of thestart-up process. We are engaged in discussions with the FDA concerning the study design and end points. Depending on trial results, we plan to seek product approval in both the U.S. and the European Union.
We plan to rely on our current DCVax ® -Brain Phase II clinical trial as a single study in support of regulatory approval. However, to date, only eleven patients have enrolled in the clinical trial,
which is designed to include 240 patients. Given our current lack of funding, it is unclear how quickly we will be able to increase enrollment, if at all.
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