NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

Who I Am and Why I Am So Outraged by Feuerstein’s Reckless Disregard for the Truth


I want to explain why I have written a letter to the Henrys, the owners of Stat News, demanding (yes demanding) that they retract and apologize for an article written on May 10, by Adam Feuerstein. Feuerstein is an employee of Stat News. He falsely claimed that Northwest Biotherapeutics’ autologous cell therapy, DCVax-L, had failed a pivotal phase 3 trial in glioblastoma multiforme. In point of fact, the phase 3 trial was a stunning success as the primary endpoint of median overall survival in newly diagnosed glioblastoma multiforme had a p value of <0.002 and the primary endpoint of median overall survival in recurrent glioblastoma multiforme had a p value of <0.001.

These results were presented at the prestigious New York Academy of Sciences conference on May 10, 2022. Feuerstein totally misrepresented these results in his article and made up a fictional story claiming that the trial had failed. His reckless disregard for the truth cannot be allowed to stand. I ask those of you who are as outraged as I am to join with me in my effort to get Stat News to acknowledge that the actual phase 3 trial results were extremely positive and to deal harshly with Feuerstein.


Let me explain why I am so outraged with Feuerstein. I have been involved in security analysis all my adult life and pride myself on my ability to discover exceptional businesses and the people behind them who change the world. About 8 years ago, a close friend and client, Arnold Milton, told me about Northwest Biotherapeutics which was developing DCVax-L. Arnold had developed glioblastoma and after being unsuccessfully treated with standard of care (surgery followed by radiation and chemotherapy) sought out new forms of therapy. In his research, he came across highly encouraging phase ½ results for DCVax-L suggesting an impressive survival benefit and also anecdotal stories of long term survival achieved by patients who had received DCVax-L under compassionate use protocols. I only wish that DC Vax-L had been available in the United States when Arnold was first diagnosed. He died in 2016.

This started my involvement with DCVax-L. I was further incented when my best friend developed GBM and died 16 months after treatment; on balance 50% of patients die within 16 months. I was impressed by the information uncovered by Arnold and dug deeper. I found that the phase 3 trial was headed by two outstanding neurosurgeons-Dr. Linda Liau (co-inventor of DCVax-L) from UCLA’s David Geffen School of Medicine and Dr. Keyoumers Ashkan from King’s College in London. Both were highly encouraged that patients in the trial (even though it was still blinded) were living longer. An analysis of blinded data from the trial in 2018 also strongly suggested a mortality benefit.

Nothing is sure in biotechnology, but any reasonable person had to be encouraged. To my astonishment, I soon discovered the dark force of Adam Feuerstein. He ridiculed everything about DCVax-L and disparaged Drs. Liau and Ashkan. (Note that Feuerstein’s degree is in political science.) He has written over 500 negative comments over the last ten years on DCVax-L and Northwest Biotherapeutics, on Twitter, iHub, Seeking Alpha, The Street.com and now Stat News. Clearly, Feuerstein has a vendetta and he is not going to let truth stand in his way.

I thought that the extremely impressive results of the phase 3 trial would prove my case (as it did) and silence Feuerstein. Instead, he made up a fictional story and claimed that the trial failed and escalated his attack on DCVax-L. This cannot stand. Again, I urge you to join with me in in my effort to get Stat News and the Henrys to acknowledge the truth about the phase 3 trial and to deal harshly with Feuerstein.

Discussion of the Feuerstein Article

The Feuerstein Stat News article demonstrated flagrant disregard for accurately reporting on what was presented on May 10, 2022 at the New York Academy of Sciences by Dr. Mulholland, an investigator in the trial and a strong advocate of DCVax-L. Here is the link to that presentation. https://virtualtrials.org/dcvax/dcvax.pdf (5/10/ 22 presentation by Dr. Mulholland). Dr. Mulholland concluded that the trial successfully met its endpoint and stated that DCVax-L was a major advance in the treatment of glioblastoma and would give desperately ill patients the legitimate hope that their lives might be extended. Feuerstein , drawing on his political science background , called the trial a failure.

A new article recommending purchase of Northwest Biotherapeutics was published on Seeking Alpha on May 21. Here is the link to that article. https://seekingalpha.com/article/4513591-northwest-bio-buy-again-wait-for-regulatory-process In the comments section of the article there is overwhelming support for Northwest Biotherapeutics and overwhelming condemnation of Feuerstein’s article. I was particularly impressed by a comment to that article that was posted by Larry Smith of SmithOnStocks at 7:29 AM on May 22. I urge you to read Smith’s comments in full as well as the Seeking Alpha article and the comments following it. In particular, I would call attention to one section of the Smith’s comments. He shows the Feuerstein article in its entirety and interjects at various points facts which clearly show that Feuerstein misrepresented the NYAS presentation. Smith terms the Feuerstein report a work of fiction.

Here is Feuerstein’s full article with Smith’s clearly marked comments interspersed. The blatantly misleading article starts with a blatantly misleading headline.

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.

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.)

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.

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.

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.)

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.
https://smithonstocks.com/northwest-biotherapeutics-fda-statement-regarding-use-of-external-controls-in-clinical-trials-is-a-huge-positive/. 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: Seventy 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 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.)


Approaching The Henrys

On May 19, 2022 I wrote to Linda Henry, the CEO of The Boston Globe and Stat News. Mrs. Henry, and her husband, John, own The Boston Globe (Stat News is a subsidiary) and also the Boston Red Sox. My objective was to bring Feuerstein’s conduct to the attention of the Henrys. It is highly unlikely that they are involved in the production and editing of Stat News articles. I wanted them to be aware that Feuerstein’s conduct is a stain on Stat News, the Boston Globe and their good reputations. I am also urging them to harshly deal with him. In my view, his conduct is a firing offence. I then published this letter on iHub.

After reading my May 19th letter on IHUB, an oncologist contact pointed out that I had made a meaningful (certainly unintended) error in saying that progression free survival was a secondary endpoint in the trial and I quickly determined that he was correct. In no way does progression free survival figure into the statistical analysis plan (SAP) that regulators will use to evaluate the trials results. Based on my conversation with my oncologist friend, I have corrected this error in my first letter and have sent a second letter to the Henrys with this correction. I am also publishing this second letter on IHub. In an effort to be as transparent as possible I am republishing the first letter in the case that people want to compare the two.


Second Letter to the Henrys


Here is my second letter to the Henry’s in which I corrected my error in stating that progression free survival was a secondary endpoint.



Joseph H Pratt

9 Northwoods

Radnor, PA 19087

610 517 4445

[e-mail]



Linda P Henry
The Boston Globe
53 State St Lobby 2
Boston, MA, 02109-3208


May 22, 2022

Dear Ms. Henry,

On May 19th, I wrote you a letter to make you aware of some very troubling conduct by one of your Stat News employees, Adam Feuerstein. Unfortunately, I mistakenly stated that progression free survival was a secondary endpoint of the DCVax-L. This is quite material and this second letter explains the importance of this and also repeats in full other parts of the first letter. You should disregard the first letter and use this second letter in any deliberations on how you might address the actions of Mr. Feuerstein.

On May 10th, a peer reviewed paper was presented on DCVax-L (a drug developed by Northwest Biotherapeutics) at the prestigious New York Academy of Sciences. This drug is a vaccine targeted at glioblastoma multiforme, the deadliest form of brain cancer in which 50% of newly diagnosed patients die within a year and one half. A distinguished neuro-surgeon who participated in the trial presented the results of a near 15 year study of DCVax-L which showed that DCVax-L increased survival in newly diagnosed glioblastoma multiforme as evidenced in a very meaningful way with a stunning p-value of <0.002. The presenter stated that he felt that this represented a major breakthrough in the treatment of GBM and proclaimed the trial a major success. Importantly, he thought that would give desperately ill GBM patients hope that their life could be extended with the use of DCVax-L. He further emphasized that its side effects were placebo-like in sharp contrast to the life threatening side effects of most cancer drugs,

Shortly after the presentation, Feuerstein published an article that falsely stated that the trial had failed because statistical significance was not reached on progression free survival. This was a glaring misrepresentation as the NYAS presentation clearly stated that overall survival was the primary endpoint and was demonstrated with extremely impressive statistical significance. In oncology trials, median overall survival as used in the DCVax-L trial is the gold standard for end points. There is no harder or more definitive endpoint than survival for judging if a drug is effective.

ClinTrials.gov is a government run website that provides definitive information on trial designs. In the case of the DCVax-L it states that the outcome measures as laid out in the statistical analysis plan are as follows: (Note that progression free survival is not mentioned.)

· The primary objective of this study is to compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in newly diagnosed glioblastoma. [ Time Frame: Until death ]


· The first secondary objective is to compare overall survival (OS) between patients randomized to placebo who received DCVax-L treatment following disease recurrence, and control patients from comparable, contemporaneous clinical trials, in recurrent GBM. [ Time Frame: Until death]


Feuerstein made an absolutely unforgivable and apparently intentional error in claiming that the trial had failed because it did not show statistical significance on progression free survival which doesn’t even figure into the statistical analysis plan. How could he make such a mistake? Maybe this is the reason. When the trial was begun over 15 years ago, chemotherapy drugs were overwhelmingly used to treat cancer. If chemotherapy drugs work, they rapidly shrink the size of the tumor and hopefully keep the tumor from growing (progressing). So when the DCVax-L trial began, median progression free survival seemed an appropriate endpoint. However, some years into the trial, it became clear to investigators that this is a totally inappropriate endpoint.

DCVax-L is an immunotherapy drug like the checkpoint inhibitors (Opdivo, Keytruda). These drugs work very differently from chemotherapy drugs which are essentially poisons that kill cancer cells, as well as some bystanding normal cells. Immunotherapy drugs recruit cells of the immune system to attack cancer cells. As they kill cancer cells, they result in inflammation at the tumor site. Imaging scans then show swelling that can be misinterpreted as progression of the tumor. This is a phenomenon that is known as pseudoprogression. In fact, pseudoprogression may be an indication that the drug is working. Investigators in the study realized that median progression free survival was totally inappropriate. Over two years ago, the statistical analysis plan was changed to the overall survival endpoints as described above. This was done before the data was unblinded and is perfectly acceptable to regulators.


During the presentation at the New York Academy of Sciences, the presenter showed that progression free survival was not statistically significant. He emphasized that it was not in any way an endpoint of the trial. He showed this just to illustrate that overall survival is the only appropriate endpoint for immunotherapy drugs and that median progression free survival is meaningless.


Feuerstein recklessly and perhaps maliciously claimed that the primary endpoint was progression free survival and boldly stated that the trial had failed. This was in direct contradiction to what the presenter at the New York Academy of Sciences clearly stated. There is no reprimand sufficient for what Feuerstein did. It went beyond being reckless, malicious, stupid and a lot of other adjectives. His article was quickly and widely circulated by hedge funds, who were short the stock, to Wall Street trading desks leading to a dramatic collapse in the stock price. At the close on May 9th, the stock was at $1.80 and then plunged to a low price of $0.38 on May 10th. Some 77 million shares traded that day and the only negative news was Feuerstein’s false claim that the trial had failed. Feuerstein bragged about the impact his article had on the stock.


Feuerstein and Stat News clearly have to face up to the great harm they have caused investors. I think that Feuerstein and Stat News should immediately retract the article and apologize for ever allowing this article to be published. Perhaps more seriously, Feuerstein has conducted a decade long campaign against Northwest with the clear and stated aim of bankrupting Northwest Biotherapeutics and blocking development of DCVax-L. Feuerstein has to answer to cancer patients as well as investors.


Feuerstein has targeted Northwest and DCVax-L for over 8 years with false and misleading tweets and recently with articles at Stat News. He has repeatedly claimed that the trial failed even before the data was unblinded and has accused management of various types of criminal behavior. His vehemence is stunning and unsupported by any facts or evidence. I have a collection of over 500 negative comments that he has made that demonstrate extreme bias and malevolence; these are all available for your review.

I am also troubled by reports of reprehensible conduct by Feuerstein immediately prior to the May 10th presentation. It is alleged by a whistleblower that Feuerstein aggressively tried to block the May 10th presentation at NYAS. There is a firestorm on Twitter referring with outrage to these alleged acts and condemning Feuerstein for his actions. See $nwbo and @adamfeuerstein. The originally scheduled presenter was Linda Liau, MD, PhD. She is the co-inventor of DCVax-L and one of two lead investigators on the trial. She is affiliated with UCLA’s David Geffen School of Medicine as the Chair of the Department of Neurosurgery; Professor, Department of Neurosurgery; and Director, Brain Tumor Program. It is alleged that Feuerstein has been harassing Dr. Liau for years and that Feuerstein called Dr. Liau numerous times prior to May 10 and also the press office at UCLA. He is alleged to have stated that he was an investigative reporter with a widely respected news organization. He is alleged to have threatened that if Dr. Liau made the presentation at New York Academy that he was prepared to publish stories that Northwest was engaged in fraudulent activity in the conduct of the trial and that management was guilty of criminal stock manipulation. He said that if Dr. Liau presented that he would ruin her reputation and that of UCLA. Ultimately, Dr. Liau did not present. She is a very sweet, non-confrontational lady focused on science and not the rough and tumble world of Adam Feuerstein.


Feuerstein is said to have used the same tactics on the New York Academy of Sciences. However, they were aware of Feuerstein’s reputation as a collaborator with certain hedge funds. After his approach, he was reprimanded for his behavior and banned from attending the presentation either in person or virtually.

If indeed, Feuerstein did attempt to interfere with presenters, I can not emphasize enough the extreme seriousness of such actions. It is not the role of a reporter to try to influence scientific dialogue. Science is sacrosanct and it Feuerstein did contact Dr. Liau and the NYAS in the manners alleged, it seems to me to be a firing offence.

I urge you to aggressively follow up on these allegations to ascertain if they are correct. I believe them to be, but at this time have not seen hard evidence. However, tweets suggest that in a matter of days there may be such. If this is shown to be true, Feuerstein has clearly gone far beyond the accepted role of reporting by playing an active role in the complete collapse of the stock and leading to hundreds of millions of profits for hedge funds who shorted the stock and a like number of losses for legitimate investors. I am also morally appalled that he would go to such efforts to block the development of a very badly needed new drug for glioblastoma.



CC: John Henry



First Letter to the Henrys in Case You Want to Compare to the Second Letter


Joseph H Pratt

9 Northwoods

Radnor, PA 19087

610 517 4445

[e-mail]










Linda P Henry

The Boston Globe

53 State St Lobby 2

Boston, MA, 02109-3208

May 19, 2022


Dear Mrs. Henry ,


I am writing to make you aware of some very troubling conduct by one of your Stat News employees, Adam Feuerstein. On May 10th, a peer reviewed paper was presented on DCVax-L (a drug developed by Northwest Biotherapeutics) at the prestigious New York Academy of Sciences. This drug is a vaccine targeted at glioblastoma multiforme, the deadliest form of brain cancer in which 50% of newly diagnosed patients die within about one year. A distinguished neuro-surgeon presented the results of a near 15 year study of DCVax-L which showed that DCVax-L increased survival in a very meaningful way with a stunning p-value of <0.002. The presenter stated that he felt that this represented a major breakthrough in the treatment of GBM and proclaimed the trial a major success.


Shortly after the presentation, Feuerstein published an article that falsely and malevolently stated that the trial had failed because it did not achieve statistical significance on a secondary endpoint of progression free survival. This was irrelevant as overall survival is the gold standard endpoint for oncology clinical trials. Because of a phenomenon called pseudoprogression it was widely anticipated that progression free survival would not be reached and that this was a meaningless endpoint. His article was quickly and widely circulated by hedge funds, who were short the stock, to Wall Street trading desks leading to a dramatic collapse in the stock price. For the close on May 9th, the stock was at $1.80 and then plunged to a low price of $0.38 on May 10th. Some 77 million shares traded that day and the only negative news was Feuerstein’s false claim that the trial had failed.


Feuerstein has targeted Northwest and DCVax-L for over 8 years with false and misleading tweets and recently with articles at Stat News. He has repeatedly claimed that the trial failed even before the data was unblinded and has accused management of various types of criminal behavior. His vehemence is stunning and unsupported by any facts or evidence. I know of a collection of over 500 negative comments that he has made that demonstrate extreme bias and malevolence; these are all available for your review.


I am also troubled by reports of reprehensible conduct by Feuerstein immediately prior to the May 10th presentation. It is alleged by a whistleblower that Feuerstein aggressively tried to block the May 10th presentation. The originally scheduled presenter was Linda Liau, MD, PhD. She is the co-inventor of DCVax-L and one of two lead investigators on the trial. She is associated with UCLA David Geffen as the Chair of the Department of Neurosurgery; Professor, Department of Neurosurgery; and Director, Brain Tumor Program. It is alleged that Feuerstein called Dr. Liau numerous time prior to May 10 and also the press office at UCLA. He is alleged to have stated that he was an investigative reporter with a widely respected news organization. He is alleged to have threatened that if Dr. Liau made the presentation at New York Academy that he was prepared to publish stories that Northwest was engaged in fraudulent activity in the conduct of the trial and that management was guilty of criminal stock manipulation. He said that if Dr. Liau presented that he would ruin her reputation and that of UCLA. These charges are a complete fabrication. Dr, Liau did not present. She is a very sweet, non-confrontational lady and was badly shaken by Feuerstein’s aggressive and coercive tactics.


Feuerstein used the same tactics on the New York Academy of Sciences. However, they were aware of Feuerstein’s reputation as a collaborator with certain hedge funds. After his approach, he was reprimanded for his behavior and banned from attending the presentation either in person or virtually. We urge you to aggressively follow up on these allegations to ascertain if they are correct. We believe them to be, but at this time we do not have hard evidence. However, in a matter of days we hope to have such. Feuerstein appears to have gone far beyond the accepted rules of reporting by playing a major role in the complete collapse of the stock and leading to hundreds of millions of profits for hedge funds who shorted the stock. I am also morally appalled that he would go to such efforts to prevent the approval of a very badly needed new drug for glioblastoma.


Earlier, I presented part of the SmithOnStocks comment on the Seeking Alpha article in which he pointed out the glaring errors in Feuerstein’s Stat News article. Here are his complete comments.


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Purpose of This Comment
I am in agreement with your key points and believe that the trial was a spectacular success. Understanding how pseudoprogression renders progression free survival meaningless, that median overall survival is the gold standard endpoint for oncology trials and that FDA in some situations may allow the use of external controls are critical to understanding why the trial was such a success. You do a good job on this.

The stock decline on May 10, 2022 was meaningfully abetted by Adam Feuerstein’s article on Stat News entitled “It took years, but the failure of Northwest Bio’s brain cancer vaccine is now in the open.” His report was widely circulated to news outlets, some of whom reiterated Feuerstein’s demonstrably false claims that the trial had failed. Feuerstein appears to have been a catalyst in the stock decline.

The number of market makers for Northwest is usually about 6, but on May 10, there were 13 market makers; more market makers facilitates shorting. Hmmm. There were 77 million shares traded on May 10 and I believe that based on past experience that 80% could have been counterfeit shares (created through naked shorting).

In this comment, I present Feuerstein’s report in full and my critique of his demonstrably false assertion that the trial failed. I have not edited the Feuerstein report in any way. However, I do add editorial comments at certain points to interject actual facts into what I consider to be his work of fiction. I am stunned at how he grossly misrepresented the results of the trial as presented at the New York Academy of Sciences on May 10. His comments are frankly childlike and totally misrepresent the data that was presented.

NYAS Presentation on DCVax-L Phase 3 Trial Was Extremely Positive

The NYAS presentation can be viewed on You Tube at this link. virtualtrials.org/...

Some of the key data slides are as follows:

Slide 29: Kaplan Meier analysis shows that DCVax-L met median overall survival primary endpoint in newly diagnosed GBM with a strong p value of less than 0.002.

Slide 30 Survival tail in ndGBM showed 13.0% of patients alive at five years versus 5.7% in control group. This is every bit as impressive as survival tails for the checkpoint inhibitors in recurrent non-small cell lung cancer and recurrent melanoma, cancers which are roughly equivalent to glioblastoma in terms of survival.

Slide 39: Kaplan Meier analysis shows that DCVax-L met median overall survival primary endpoint in newly diagnosed GBM with a strong p value of less than 0.001.

Slide 40:The survival tail for DCVax-L in recurrent GBM showed that at 30 months 11.1% of GBM patients were alive versus 5.1% in the control arm.

It is important to understand that the actual endpoints of the trial were median overall survival. These are described on the government website ClinTrials.gov. Here is the link. clinicaltrials.gov/... The phase 3 trial was designed to evaluate the impact on survival time, as well as safety, in patients following treatment with DCVax(R)-L, an immunotherapy treatment for GBM. The control arm was based on 1,366 patients who received standard of care in several glioblastoma trials that ran concurrently with the DCVax-L phase 3 trial. FDA officials in the oncology division have recently signaled that the use of external controls may be acceptable in some cases. See this link. smithonstocks.com/...

According to ClinTrials.gov. the primary study endpoint is OS (overall survival) compared to external controls in newly diagnosed glioblastoma, and the first secondary endpoint is OS compared to external controls in recurrent glioblastoma. In judging how dishonest the Feuerstein article is, it is critical to understand that progression free survival is not part of the statistical analysis plan. It is not even a secondary endpoint. However, Feuerstein claims that the trial was a failure because it did not show statistical significance on progression free survival. This is just a blatantly false representation of results.

The Feuerstein Report Blatantly Misrepresents Actual Results as Presented at NYAS

Here is Feuerstein’s full article with my comments interspersed.

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.

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.)

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.

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.

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.)

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.
smithonstocks.com/...
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: Seventy 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 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.)