NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

AACR HAS JUST PUT OUT AN UPDATED VERSION OF ITS 5/13/22 ARTICLE ON MULHOLLAND 'S 5/10/22 NYAS TLD PRESENTATION ON THE DC VAX L PHASE 3 TRIAL .THE ORIGINAL AACR ARTICLE(5/13) APPEARED TO HAVE BEEN WRITTEN BASED ONLY ON INFORMATION CONTAINED IN ADAM FEUERSTEIN'S 5/10/22 STATNEWS /BOSTON GLOBE ARTICLE WHICH IS SHOWN BELOW . SEE TWITTER LINK BELOW FOR THE ORIGINAL 5/13/22 AACR ARTICLE.

https://aacrjournals.org/cdnews

We hereby demand that @AACR @AACRFoundation retract, apologize, and remedy the severe and ongoing damage to patients and Northwest Biotherapeutics from their incorrect reporting of the Phase 3 DCVax-L GBM trial results. $NWBOhttps://t.co/Ygn0i5gbqo

Vote, like, and retweet!

— Carlo Rago, PhD (@rago_carlo) May 15, 2022

The prior statement regarding DCVax-L, published May 13, has been removed. An updated version of the statement appears below.]

Since the first announcement of the DCVax-L Phase 3 glioblastoma (GBM) trial results presented by Dr. Paul Mulholland on May 10, 2022, at the New York Academy of Sciences (NYAS) Conference on Frontiers in Cancer Immunotherapy, Northwest Biotherapeutics ("Company") has indicated that our prior statement did not include certain information contained in the presentation, including the updated primary and secondary endpoints of the trial.

The Company believes the presentation shows that DCVax-L-treated patients, when compared to external controls, exhibited a clinically meaningful and statistically significant extension of survival in both newly diagnosed and recurrent GBM, which are the two updated endpoints of the trial. For details regarding the full presentation at NYAS, please see the following: https://virtualtrials.org/dcvax/dcvax.pdf

:: Continued in our Noted This Week Archive ::



https://smithonstocks.com/northwest-biotherapeutics-debunking-silly-fictitious-adam-feuerstein-article-falsely-claiming-phase-3-trial-of-dcvax-l-in-glioblastoma-multiforme-was-a-failure/?co=northwest-biotherapeutics

The Feuerstein Report Blatantly Misrepresents Actual Results as Presented at NYAS

Here is Feuerstein’s full article with my comments in italics interspersed. I obtained this article from an IHub posting that was sent to me.



It took years, but the failure of Northwest Bio’s brain cancer vaccine is now in the open

By Adam Feuerstein May 10, 2022


After years of delays and excuses, Northwest Biotherapeutics finally disclosed on Tuesday the final results from a late-stage clinical trial of its personalized cancer vaccine administered to patients with brain tumors. The treatment’s data are as bad as expected — performing worse than a placebo.

(SmithOnStocks comment. Over the last nine years, F-Stein has penned more than 500 negative comments on Twitter, TheStreet.com, IHub and Seeking Alpha. All were negative and all were based on no evidence and dripping with malice. He first claimed that the trial failed some eight years ago, long before the data was unblinded. He has accused management of manipulating data in the phase 3 trial, securities fraud and running a Ponzi scheme siphoning money from the company, and more.)


Patients administered the Northwest Bio treatment, called DCVax, went a median 6.2 months without their brain tumors returning compared to a median of 7.6 months for patients offered a placebo.

(SmithOnStocks comment: Progression free survival was not the endpoint. The endpoint was median overall survival as previously described. In point of fact, PFS is not even a secondary endpoint.)


Overall, patients treated with DCVax had a 10% higher risk of tumor progression compared to placebo — an outcome that is the antithesis of what’s required from any effective cancer treatment.

(SmithOnStocks comment: This is meaningless).


DCVax is a cancer vaccine, meaning it’s designed to stimulate the body’s own immune system to find and kill cancer cells. Some immunotherapies have been shown to prolong survival despite minimal effect on tumor shrinkage. That wasn’t the case with DCVax. The Northwest Bio study was also designed to measure and compare the overall survival of DCVax and placebo patients, but the company chose not to disclose those survival data on Tuesday — for reasons that are now clear.

(SmithOnStocks comment; The presentation clearly noted that the trial reached the primary endpoint of median overall survival in newly diagnosed glioblastoma multiforme with a stunning p value of <0.002. It also reached the secondary endpoint of median overall survival in recurrent glioblastoma multiforme with a p-value of <0.001. Feuerstein omits any mention of this and actually claims that survival data was not presented.)


The Phase 3 study enrolled 331 patients with newly diagnosed glioblastoma, an aggressive form of brain cancer. DCVax was administered to 232 patients; 99 patients received a placebo. The final data were presented at a cancer immunotherapy meeting sponsored by the New York Academy of Sciences.

(SmithOnStocks.com This is the only thing in the article that was correct.)


Nineteen months have passed since Northwest Bio announced that the DCVax study had reached “data lock” — a standard step in the closure of a clinical trial that ordinarily leads quickly to data analysis and the announcement of the study outcome. “We are excited to be so close to the finish line now, after such a long road,” said Linda Powers, Northwest Bio’s CEO, in an Oct. 5, 2020, press release.


Instead of acknowledging the futility of its brain tumor treatment, Northwest Bio used the long interregnum to concoct a false, alternative reality in which the study was successful and DCVax extended the lives of patients.

(SmithOnStocks.com Over 40 clinicians who participated in the trial had to sign affidavits in which they attested to the integrity of the results. Hence, F-stein is alleging corruption and illegality on the part of all physician participants as well as Northwest.)


To do this, the company discarded the overall survival data from the 99 patients randomized to treatment with a placebo. Those original, prespecified data were thrown out, and replaced on a post-hoc basis with survival data collected from 1,366 patients who participated in five entirely separate and previously completed clinical trials.

(SmithOnStocks comment: The 99 patients randomized to placebo were not thrown away. Those who progressed were categorized as having recurrent GBM. After progression, they were crossed over to DCVax-L and they formed the basis for an analysis of median overall survival in recurrent glioblastoma multiforme. The p value for this group was stunning at <0.001. This is the first clinical trial that has shown efficacy in recurrent GBM)


When the 233 patients treated with DCVax were compared to the 1,366 patients taken from “external controls,” Northwest Bio said it found a 20% relative reduction in the risk of death. At the median, the DCVax patients lived for 19.3 months compared to 16.5 months for the make-believe group of control patients.

(SmithOnStocks comment: Feuerstein mocks the use of external controls. However, key employees in the oncology section of the FDA recently published an article in which they stated that in some cases, it is appropriate to use external controls as a control arm. See my article Northwest Biotherapeutics: FDA Statement Regarding Use of External Controls in Clinical Trials is a Huge Positive at this link. Northwest was very careful to present results for their external controls in accordance to suggestions made by this FDA officials.)


When you throw a dart against a wall first, and then paint a bullseye, it’s really easy to declare a win. It’s not, of course. It’s cheating. And that’s what Northwest Bio did with the analysis of its DCVax study.

(SmithOnStocks comment: Again, over 40 clinical trial investigators involved in the trial attested to the accuracy of the results. Feuerstein with his strong political science background maintains they are all wrong. He is delusional.)


Northwest Bio shares plunged 70% on Tuesday once the DCVax presentation concluded. After a brief rise to around $2 per share in the run-up to Tuesday’s event, the stock is now trading again well below a buck.

(SmithOnStocks comment: The only negative printed news on May 10 was the article by Feuerstein which was fed to news outlets and Wall Street trading desks. Feuerstein is taking credit and bragging about how he was able to crush the stock price)


No one was fooled.

(SmithOnStocks comment: No one is fooled by Adam Feuerstein.)