Do I believe DC vaccines are safe? Yes, no question. Do they exhibit some beneficial immunomodulatory effect? That is also a yes. I have stated both of those things previously and I have personally run trials on DC vaccines for indications other than GBM so I know firsthand what the technology can do.
Is the evidence available at present sufficient to get DCVax approved as a monotherapy for GBM? No. Can it potentially get approved as part of a combination therapy? Yes, but that will require a combination products trial which is not quick, cheap, or simple.
There are only two regulators that matter in the world and those are the FDA and EMA since they are the gatekeepers to the only two markets large enough to provide drug makers an economic return on their investment. NWBO can continue to sell in places where regulatory approval is not required for autologous products, such as in Germany pursuant to Article 4 of the AMG, but that is something the company has been able to do from day one, but a broader approval will be difficult to come by without more evidence.
Possibility is not the same thing as economic feasibility.
Me:
Re: presentation slides
I fully understand your stance, and mine is also very clear. Thank you for following up in reply.
Maybe you can change your mind after publication which I believe will contain more convincing efficacious evidence.
by
[So now he agrees DCVax-L is somewhat efficacious, but maybe just short of approval.]
Many email exchanges with the company confirm the following information
In 2020 when eu clinical trials register revealed the updated endpoints (https://www.clinicaltrialsregister.eu/ctr-search/search?query=dcvax), the price moved to as high as $2.2; since damage is done, this time around thing may unfold differently. Damage may need time to repair. Nonetheless, it's a great piece of news.
Now even Principal Investigator Dr. Liau and her fellow academicians are threatened, coincided with share price manipulated sharp drop from $2 to $0.39.
When huge $ is at stake, the short and their associates will do anything unimaginable. Free country of course.
The company has had no guideline with regard to when. What we can look forward to is the company has to sent out proxy material to shareholders to review and vote before shareholders meeting which should happen in late June; CTO Dr. Bosch will have a presentation at ASCO in early June.
In the meantime, TLD/journal article may drop any days (yet nobody knows the timeline).
Now the company has been prohibiting from publiclly defending its position for the reason many believe related to embargo of journal publication.
Company representative DI has told me the company has been busy on a few parallel tasks besides TLD/publication, so maybe preparation for filing BLA (not NDA in nwbo's case, it's not a drug but a biological product for approval) is one; maybe in effect the company has filed a rolling BLA to regulatory agencies.
F-stein Challenges Members of the Oncology Community Who Treat Glioblastoma Multiforme Adam Feuerstein has thrown down the gauntlet in alleging that over 40 practicing oncologists who participated in the phase 3 trial of DCVax-L have misrepresented the findings. The results of the phase 3 trial...
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Adam Feuerstein Is Facing a Firestorm of Criticism for His Misrepresentation of Results in the Phase 3 Study of DCVax-L in Glioblastoma Multiforme; A Practicing GBM Physician Chastises Him
F-stein Challenges Members of the Oncology Community Who Treat Glioblastoma Multiforme
Adam Feuerstein has thrown down the gauntlet in alleging that over 40 practicing oncologists who participated in the phase 3 trial of DCVax-L have misrepresented the findings. The results of the phase 3 trial were presented at the New York Academy of Science on May 10 and the physician participants who conducted the trial had to sign affidavits attesting to the integrity of the results shown in the paper. The key conclusions as presented by one of the clinical trial investigators were that DCVax-L was very successful in achieving the primary endpoint of median overall survival in newly diagnosed glioblastoma multiforme with a p value of less than 0.002. The secondary endpoint in the trial was median overall survival in recurrent glioblastoma multiforme which was achieved with a p value less than 0.001. Note that no drug has ever shown a survival benefit in rGBM.
While this data needs to be parsed and reviewed in a peer reviewed medical journal (a process now underway) and ultimately evaluated by regulatory agencies (in an even more rigorous process), physicians involved in the trial or who were aware of the results were greatly impressed. Not so fast says F-stein who proudly flaunts a degree in political science. He declared the trial a failure. On May 10, he wrote an article entitled “It took years, but the failure of Northwest Bio’s brain cancer vaccine is now in the open”. F-stein chided the oncologists. He said that the real endpoint of the trial should have been progression free survival and when judged on this basis, the trial failed. His analysis (sic) concluded that progression free survival is much more important than data showing whether patients treated with DCVax-L experienced meaningfully greater lengths of survival.
F-stein has dealt especially harshly with the two lead investigators in the trial. Dr. Linda Liau (co-inventor of DCVax-) and Keyoumers Ashkan of King’s College in London. Both of these neuro-oncologists are highly distinguished and respected in the GBM community. Google them. They have both represented that many patients whom they have treated with DCVax-L have experienced an impressive survival benefit. GBM patients when first diagnosed with GBM are told that they have a 50% chance of living for a year and one half and a 5% chance of living for 5 years. Dr. Liau and Dr, Ashkans believe that with DCVax-L, they can give their patients the hope for longer survival. However, F-stein has schooled them that they are misleading patients because they do not realize that the phase 3 trial failed when judged on his selected endpoint of progression free survival. Who cares about actual survival?
It has been pointed out to F-stein by me and many others that progression free survival is particularly meaningless in evaluating immunotherapy drugs like DCVax-L. Their mechanism of action mobilizes T-cells to attack the tumor cells and in doing so results in inflammation. Imaging modalities such as MRI and CT then detect a swelling at the tumor site which can be misinterpreted as progression of the tumor. In point of fact, this probably indicates that the drug is effective. So far, F-stein has retained a stony silence on this point which, if true, totally destroys his argument that the trial failed. A Prominent Neuro-Surgeon Harshly Reprimands Adam Feuerstein
As long as it was the powerful F-stein social media platform (more on this later) versus NWBO, it was a mismatch. However, F-stein has unwittingly flipped the playing field. He is now taking the GBM physician community head on. I have heard accounts from GBM physicians expressing outrage with F-stein, but these have been internal conversations. However, this appears to be spilling over into public denunciation of F-stein. In this section, I show a series of tweets from a physician, Dr, Steven Toms, who actually treats GBM patients. He has impressive credentials and I think that his comments are a strong indicator of how his colleagues feel about F-stein’s string of lies. He tears the inane F-stein arguments apart.
Steven A Toms is a board certified neurosurgeon at Rhode Island Hospital. I do not know Dr. Toms and have not spoken to him (yet), but I was impressed when I Googled his credentials. He is a professor of Neurosurgery, Medicine and Health Services, Policy and Practice at The Warren Alpert Medical School of Brown University. He has been the principal investigator of both basic and clinical research studies, including studies on the development of therapeutic approaches for primary brain tumors and cancer metastasis to the brain. He is currently the Director of the Brain Tumor Program for Lifespan Health Systems and is jointly responsible for the Gamma Knife and Cyberknife units with Radiation Oncology.
Dr. Toms has been published in over eighty medical journals and multiple book chapters. He has edited one book and served as editor and reviewer for a number of publications. He is a member of the American Association of Neurological Surgeons, the Congress of Neurological Surgeons and the Society for Neuro-Oncology.
Dr. Toms is sharply critical of F-stein and has actively tried to engage F-stein on Twitter. F-stein has failed to respond. No surprise. F-stein on Twitter is blocking almost all people who challenge him. Here is what Dr. Toms has expressed in a number of tweets.
May 11 1:55 PM
StevenToms11 Replying to MidwestHedgie and adamfeuerstein and 4 others
As a neurosurgical oncologist who has spent his career working against this disease and the father of a cancer survivor it is nauseating to see you and your ilk diminish the life’s work of my colleague (Linda Liau) for a quick Buck. The data’s imperfections do not diminish the results.
May 11, 2022 8:52 PM
StevenToms11
No immunotherapy (vaccine or ICB) has worked in GBM as the CNS is immunologically privileged. DCVax has overcome the immunosuppressive environment and is the 2nd clinical trial recently to reach significance in GBM. More to do but a good step forward. (A trial of the TTF medical device developed by Novocure was the first)
May 12, 2022 6:30 AM
Replying to @adamfeuerstein and @MidwestHedgie
So when will MidwestHedgie and adamfeuerstein come look my patients in the eye and tell them they cannot have a therapy with 20+ years of investigation, a $1B clinical trial and backing of the oncology community then I will engage them again. Otherwise it is just noise.
May 12, 2022 9:58 AM
Replying to adamfeuerstein and MidwestHedgie
Repeating your lies do not make them truths. In all of your clinical experience Dr. Feuerstein can you point me to all of your long term survivors who got another therapy and lived this long? Just one that was not IDH1 mutant please. I will wait.
May 18, 2022 8:27 am
Replying to @adamfeuerstein
I see Dr. Feuerstein is back to protect patients from the clinicians who performed the study and actually care for patients with GBM. You have my name and know I am not anonymous so please stop your falsehoods. End points were changed as we began to understand pseudoprogression. May 18, 2022 8:42 AM
Replying to adamfeuerstein
Success against a plague like GBM is not presto! It is a long slog of discovery and many ideas over decades that fail to move the needle on survival. Oncologists will not ignore a scientifically sound nontoxic therapy that addresses multiple tumor antigens and improves survival
May 19, 2022 7:57 AM
Replying to @adamfeuerstein
I see the pathological lying about the data continues. Before I head to surgery I was wondering if you had the dignity or data to reply to my earlier challenges to your lies. Waiting for a cogent response to why anyone would care about PFS in immune therapy
May 26, 2022 12:53 PM
Replying to @Hygro10 and @adamfeuerstein
GBMs do not live more than 5 years other than those treated with DCVax or TTF. I have patients 5+ year survival treated on both protocols. I have zero long term survivors in 25 years of practice without. Do the math. The p value is highly significant.
May 27, 2022 2:08 PM
Toms11Steven
@Hygro10 and @adamfeuerstein
Just emailed by Communications office at my university that a Mr. Feuerstein has emailed them to inquire about the veracity of this handle. If you think you can intimidate me or that I will remain silent while you impugn this work you are sadly incorrect.
This latest tweet from Dr, Toms is beyond alarming. F-stein is trying to intimidate doctors who speak positively on DCVax-L. This would be consistent with allegations on Twitter that F-stein intimidated Linda Liau and UCLA and tried unsuccessfully to do this with the New York Academy of Sciences. This caused them to ban F-stein from attending the conference. How Stat News can support this behavior is not understandable to me. He should be fired. What Was F-stein Up to Before the May 19 Presentation? Did He Try to Block the Presentation?
So far, the backlash at F-stein has been for his lies and inane comments on the DCVax-L trial. However, he is facing far more serious accusations that he tried to block the May 10th presentation of DCVax-L at the New York Academy of sciences.
I do not subscribe to IHub, but someone forwarded me the link to an article in which an author wrote a detailed note on that site explaining why he had written a letter to the Henrys demanding that they delete and refute the Feuerstein article that has been the subject of much comment herein. The Henrys are owners of The Boston Globe of which Stat News is a subsidiary. I think that this article and the accompanying comments have thoroughly debunked the F-stein article and I won’t touch on it. Along with most others, I consider the F-stein article a childish work of fiction. Here is the link to the IHub article .
Very importantly, there was one section in the IHub article that caught my attention because it raises an entirely new set of concerns about F-stein over and above publishing his hit piece. The author drew attention of the Henrys to a firestorm raging on Twitter $nwbo$adamfeuerstein in which numerous allegations are being made about extremely troubling behavior by F-stein before the May 10 presentation. Here is what the author wrote (in quotes) summarizing the Twitter comments.
“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 $nwbo$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 is alleged to have 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 cannot 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.”
I await the reaction of Adam Feuerstein, Stat New and the Henrys to these extremely serious allegations. Here are the questions that Feuerstein and Stat News need to answer:
Did he contact Linda Liau? How many times? In what manner-text, e-mail, phone? What did he say? Did he issue threats or warnings?
Did he contact the press office at UCLA? How many times? In what manner-text, e-mail, phone? What did he say? Did he issue threats or warnings?
Did he contact the New York Academy of Sciences.? How many times? In what manner-text, e-mail, phone? What did he say? Did he issue threats or warnings?
Was F-stein banned from the May 10 presentation at the NYAS? If so, why?
I think that any type of contact by a reporter as alleged before a major presentation is inappropriate. However, if F-stein was actively trying to block the presentation that is an altogether different issue. There is no possible justification for a layman (with a political science degree) to inject themselves into a scientific forum. This would, in my opinion, be a firing offence.
I have no way of judging if these accusations are true, but they are all over Twitter and social media. Hence, I think it is incumbent upon F-stein and Stat News to answer these questions and I also think that there needs to be evidence presented by those who are alleging these actions by F-stein. If these allegations are true, F-stein has met his me-too moment.” F-stein Has Conducted a Nine Year Vendetta Against Northwest Biotherapeutics and DCVax-L
How has he been able to get with away with innumerable lies, distortions and misrepresentations is a fascinating story. He has successfully turned investor views of NWBO and its management through constantly repeating unfounded allegation. Hermann Goring said that a lie repeated just once is a lie, but a lie repeated a 1000 times becomes the truth. NWBO is a small company with a limited investor following. (This is going to change soon). The F-stein social media platform can easily overwhelm any news from the company. The story of how F-stein has gained such power and following on social media platforms is a story unto itself.
Briefly, The Street.Com was founded by Jim Cramer. Now a major commentator on CNBC, he is well known for his show Mad Money and CNBC has spent millions positioning him as a nearly infallible stock guru. With the staggering CNBC platform behind him, Cramer has created a brand that he is a friend of the small investor who can help him/her navigate through bull and bear markets. However, this hasn’t always been his mission. Before joining CNBC, he was a no holds barred hedge fund manager who would proudly rip your face off to turn a profit.
Cramer founded TheStreet.com in 1996. One of the purposes was to give short sellers a voice in the marketplace. Cramer felt that most information on stocks which came from Wall Street analysts was positively biased. He saw an opportunity to present short sellers takes on things. He was deeply integrated into the hedge fund community who were only too happy to have him publicize news that would support their positions. He could draw on the enormous resources of a broad swath of the hedge fund community to get content for his site.
Cramer is extremely dynamic and created the spot that F-stein eventually moved into. In 1999, Cramer played a role in a short attack on Dendreon that is eerily similar to F-stein and DCVax-L. See this fascinating account by Deep Capture. How Jim Cramer erected the foundation for F-steins strong platform which he inherited is going to be a chapter in my forthcoming book. F-stein joined the Street in 2001, left in 2005 to become an analyst at a hedge fund, failed at that attempt and returned to TheStreet in 2007. Using the Cramer modus operandi, he created an ever more powerful social media presence.
He has shown unbelievable malice toward Northwest Biotherapeutics over, totally out of proportion for the size of the Company. He has a venomous hatred. I have recorded over 500 negative comments over the last nine years; this Is not comprehensive however. Here is a sampling. They are staggering in their malice.
May 26, 2017
AF Tweet
$NWBO is a corporate malignancy disguised as an enterprise. …
June 11, 2014
AF Tweet
$NWBO - Enron Linda will really say anything to promote her stock. Shameless.
October 9, 2017
AF Tweet
There's likely been 2 looks at $NWBO ph3. FDA forced them into clinical hold, stopped patient enrollment bc DCVax found to be futile.
October 9, 2017
AF Tweet
$NWBO knows ph3 failed. Interim analysis came back futile. Let's hope active SEC investigation finally forces truth to be told.
1/12/2016
IHUB
DCVax does not target neo-antigens. Whoever told you that is ignorant or lying.
12/23/2015
IHUB
You're confusing "good" cancer immunotherapies i.e. checkpoint inhibitors with "bad" cancer immunotherapies i.e. old, tired dendritic cell vaccines like DCVax. The latter will not find a place in medicine because they're impotent.
No one is trying to slow down NWBO. The company has done this on its own, in large part because no one is interested in their technology.
2/16/2017
IHub
I'm sure you already know I don't believe in any of the cancer vaccine technology NWBO is developing. DCVax L and Direct will surely fail and never be approved. There's no reason to believe otherwise. All the Linda Powers/Cognate self-enrichment stuff is fun, but the fundamental bear thesis against NWBO is based on the impotence of the DCVax platform.
5/20/2016
IHub
There's never been anything positive to write about NWBO.
12/23/2015
IHub
Linda Powers is happy because much of the money raised today will flow through Cognate and into her bank account. Merry Christmas, Linda!
10/20/2016
IHUB
The SS NWBO is sinking but Captain Linda is already in the lifeboat by herself, rowing away.
1/6/2016 IHUB
Happy New Year!
Well...
For Linda. For you, not so much.
12/19/2015
IHUB
The only reason NWBO acts so secretly is because it helps them stretch out the timelines and keep the payday spigot flowing. Linda and her friends are getting rich. Look at all the money that's flowed from Neil Woodford, through NWBO, into Cognate and then into Linda's bank account. Millions of dollars!
6/24/2016
IHUB
There is ample justification for a real, external investigation into NWBO's business practices, particularly the constant and exorbitant flow of money from shareholders, through NWBO and to Cognate. That investigation should target Linda Powers.
October 9, 2017
AF Tweet
There's likely been 2 looks at $NWBO ph3. FDA forced them into clinical hold, stopped patient enrollment bc DCVax found to be futile.
October 9, 2017
AF Tweet
$NWBO knows ph3 failed. Interim analysis came back futile. Let's hope active SEC investigation finally forces truth to be told.
September 13, 2016
AF Replying to @herkyleese
Actually, the $NWBO spin started years ago when they buried the first interim efficacy analysis of ph3. Still MIA!
April 3, 2014
AF Tweet
$NWBO Warns FDA May Throw Out Phase III Brain Cancer Study —> Northwest Bio Warns FDA May Throw Out Phase III Brain Cancer Study … Read your 10-Ks closely, people!
10/20/2016
IHUB
The new data will show a correlation between breathing and survival of DCVax-Direct patients. NWBO has discovered that patients still breathing are living longer than patients who are not. Amazing stuff.
12/21/2015
IHUB
If you want to get picky, enrollment into the ph3 study has been sloooooow and delayed, even before they added patients and stopped screening for new patients.
That just shows you how little demand there is for DCVax. No one cares about it.
11/19/2016 IHUB
"I saw some bad stuff Monday and Tuesday. Topping the garbage list was Northwest Biotherapeutics ( NWBO.OB) -- easily the worst and most laughable presentation I saw at the conference. I almost fell off my chair when Northwest chief Linda Powers showed slides with Kaplan-Meyer survival curves demonstrating a "survival benefit" for the company's DCVax cancer immunotherapy over historical data culled from previously published clinical studies. Heck, Powers even attached a statistically significant p value to this pseudo-scientific nonsense. The entire Northwest presentation was appalling."
12/20/2015
I've analyzed the ph I/II DCVax GBM data in previous articles. It's the fundamental basis for the NWBO bear thesis (DCVax is ineffective, the ph3 will fail.) .
Manufacturing of DCVax-L Past, Present and Future presented by Dr. Marnix L. Bosch, MBA, PhD, Chief Technical Officer of NW Bio at ASCO on June 4, 2022
Autologous Tumor Lysate-Loaded Dentritic Cell Vaccination for Glioblastoma, presented by Keyoumars Ashkan, BA BSc MB BCh MD MRCP FRCPS FRCPath FRCPath PRCPCH FRCP FRCS (SN), Professor of Neurosurgery and Lead for Neuro-Oncology European Chief Investigator of the Trial, King's College Hospital, London, UK
NWBO CEO Linda Powers at Congress in July 1990. Later her dad was died from GBM, the deadest form of brain cancer. Because of that, she came across DCVax-L mmunotherapeutics vaccine, and bought the company which was in financial struggle during financial crisis 2008. Below is a video of her testimony at Congress starting from 33 minutes:
The International Competitiveness Task Force of the House Banking, Finance and Urban Affairs Committee reviewed progress being made on current General Agreement on Trade and Tariffs negotiations and focused on "foreign dumping:" the concern that foreign financial firms were selling below cost in...
More awakening. Below is a statement from an American billionaire:
Statement by Robert A. Hefner III on NWBO’s DCVax-L Phase III Trial
6 June 2022. GHK | A privately owned, globally focused investment group
Our Northwest Biotherapeutics (NWBO) investee “partner” likely has just made one of the biggest breakthroughs in the history of cancer. We know that is a really big statement so why do we at GHK believe that is possible? Because we believe the doors through which major cancer breakthroughs must pass are the human immune system, immunotherapies and personalized vaccines and NWBO has just leaped through those doors with its personalized DCVax vaccine made from your own cells.
You can argue about trial statistics until the cows come home but to us the bottom line is 1) people living longer 2) quality of life during treatments and 3) the cost of treatments.
During NWBO’s 16-year Phase III trial to treat glioblastoma (GBM), one the most difficult
and lethal of all solid tumor cancers 1) more people lived longeri, 2) it is safe with virtually no
side effects occurring and 3) NWBO estimates treatments will cost about half as much as Standard of Care chemotherapy and radiation treatments. So for the first time ever, GBM patients can have
hope! And can hope like prayer increase the effectiveness and energy of the immune system? We
think so.
We are aware we stuck our necks out when we said “possibly one of the biggest
breakthroughs in the history of cancer”. So we have listed below our three principle reasons so you can decide for yourself:
1) After 417 failed GBM trials treating 31,952 patients over decades, DCVax-L is first treatment that gives GBM patients a meaningful chance to live longer, some now living 9 to as many as 19 years and counting.
Page 2 of 3
2) DCVax was conceived and created not for glioblastoma alone but as a personalized
tool of your own immune system to defeat all solid tumor cancers and that’s 90% of
all cancersii.
3) Since DCVax’s creation NWBO has amassed an enormous rich databank containing
masses of information on patients, treatments, and DCVax’s use against 15 different solid tumor cancersiii that has not yet been analyzed by artificial intelligence (AI). We believe that in the near future when these vast amounts of data and information are teamed with AI and some of the world’s leading scientists and doctors that future generations of DCVax vaccines and protocols will experience great leaps forward in effectiveness at lower and lower costs for 90% of all cancers.
So to sum up, we believe NWBO with its DCVax immunotherapy personalized vaccines has leaped through the doors and will play a vital role in humanities great drive to defeat cancer once and for all.
6305 Waterford Blvd., Suite 470 Oklahoma City, OK 73118-1116 USA t: (405) 858-9800 f: (405) 858.9898 www.ghkco.com
