Senti, catching up on IV messages.
I read the PR to mean that "screening" is halted in Germany and elsewhere. The status of the Ph III trial "screening halt". Clever how they can get some to just think it's Germany. No need for them to clear that up for me though.
Interesting that even in their SEC document they do agree that there's a difference in using "recruited" vs "enrolled". The over 300 includes "recruited", and the 300 includes enrolled. The pipeline is the difference in my opinion.
"People familiar with clinical trials are generally aware that screening of patient candidates for eligibility is different than recruitment OR enrollment of patients for treatment." NW Bio
Pasted all documents below. Sorry on my phone, so can't put them in quotes.
NW Bio Confirms Phase III Trial of DCVax®-L for GBM Brain Cancer Is Ongoing
Patients In Trial Continuing To Be Treated Per Protocol, Including In Germany
BETHESDA, MD, August 21, 2015 – Northwest Biotherapeutics (NASDAQ: NWBO) (“NW Bio”), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, confirmed today that its Phase III trial of DCVax®-L for newly diagnosed glioblastoma multiforme (GBM) 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 (e.g., whether they are within the eligible age range, do not have certain viral diseases, etc.)
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.
Dear Regina,
Last Friday, we issued an announcement confirming that our Phase III clinical trial of DCVax®-L remains ongoing and that all patients in the trial continue to be treated in accordance with the protocol, including in Germany. We mentioned in that announcement that some 300 patients out of the anticipated total 348 patients have been enrolled in the trial.
Following our announcement, certain bloggers tried to introduce "confusion" about the enrollment number, and we received some questions from shareholders about whether the 300 were actually enrolled in the trial and being treated, or were just screened.
We addressed those questions today, and incorporated the answers in an 8-K filed with the SEC, so that all shareholders and the public can have the benefit of those answers.
The answer is that the 300 patients are actually enrolled in the trial and being treated. And, none of these 300 patients are in the Information Arm or the Pseudo-Progression Arm outside the trial.
For your convenience, you will find the relevant sections of the 8-K filing, including the questions and answers, by clicking HERE. You can access the complete filing by going to our website at www.nwbio.com and clicking on "SEC Filings" under the "INVESTORS AND MEDIA" menu tab.
Thanks for your continuing attention and support.
Sincerely,
Item 8.01 Other Events.
On Friday, August 21, 2015, the Company issued a press release confirming that the Company’s Phase III clinical trial of DCVax®-L for newly diagnosed Glioblastoma multiforme is ongoing and all patients in the trial are continuing to be treated in accordance with the protocol. The Company reported that over 300 patients have been recruited for the trial. The Company reported that the only change in the status of the trial is that new screening of patient candidates has been suspended while the Company prepares and submits certain information from the trial for regulatory review. A copy of the press release is attached as Exhibit 99.1.
The Company received various shareholder inquiries, asking whether the 300 patients are actually enrolled and being treated in the trial, or were just screened for the trial. On Monday, August 24, the Company responded by confirming that the 300 patients are actually enrolled and being treated in the trial. The Company also noted that being in the trial means not being in the Information Arm, and not being in the pseudo-progression arm, each of which are parallel with the trial but outside the trial.
A shareholder inquiry also asked what information the Company is submitting to regulators. The Company’s response noted that such submissions would not normally be discussed in the middle of a regulatory process or dialog, and that the Company plans to report when the process has been completed.
A copy of the shareholder reply is attached as Exhibit 99.2.
Shareholder Question:
Exhibit 99.2
There is a lot of confusion about your trial on the message boards. Are the 300 patients actually in the trial and being treated or are they just being screened? Also, what information are you submitting for regulatory review?
Company Answer:
Yes, the 300 patients are actually enrolled and being treated in the trial.
Also, being in the trial means that the patients are not in the Information Arm, and not in the pseudo-progression arm, each of which are parallel with the trial but outside the trial.
The supposed “confusion” about our enrollment is, once again, certain bloggers and commentators trying to turn good news into bad news about NW Bio and its trial. People familiar with clinical trials are generally aware that screening of patient candidates for eligibility is different than recruitment or enrollment of patients for treatment.
Regarding the information we are submitting for regulatory review: companies do not normally discuss such information when they are in the middle of a regulatory process or dialog, and we do not plan to do so either. We will provide an update when the process is finished and there is something to report.
