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Thank you, your posting reminded me of some recent factual sources and news links:
September 14, 2022 Update of NIH NCI Funding of Dr. Liau
https://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
https://www.bentley.edu/news/nih-funded-research-related-every-new-cancer-drug-approved-2010-2016
9/14/2022
In a trial now underway, a dendritic cell vaccine is made from a participant's own tumor tissue and combined with an anti-PD1 immune checkpoint inhibitor to counter resistance when either treatment is used alone. The checkpoint drugs work by blocking the proteins that stop the immune system from attacking cancer cells.
"What I'm excited about is that we're seeing a
growing number of long-term survivors in our
patients treated with immunotherapy
combinations," Dr. Liau says. "We're seeing some patients with certain combination
immunotherapies that are living for many more
years than would be expected. Currently, we're
trying to find out what combination works best and for which patients."
https://cancer.ucla.edu/research/ucla-brain-spore
https://www.merck.com/stories/fighting-cancer-requires-an-open-mind/
Merck: “Personalized cancer vaccines which are therapeutic vaccines based on patients’ specific cancer that could potentially prime the immune system to recognize certain characteristics and attack the cancer cells”
Fact check:
Research it for yourself:
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
https://www.bentley.edu/news/nih-funded-research-related-every-new-cancer-drug-approved-2010-2016
https://newsroom.ucla.edu/releases/nih-grant-lab-gene-cell-therapies
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
Well, it doesn’t take a genius. Just look at rGBM.
Forget platform technology and the broad potential of cell science.
Forget all solid tumors.
Forget combo therapies.
Forget Keytruda.
Forget UCLA.
Forget King’s College.
Forget MHRA.
Forget FDA-NIH.
rGBM efficacy alone is a miracle. rGBM data from 94 study sites across the globe is a miracle for the world that will lead to more miracles for any company who is wise enough to partner with Northwest Bio in this new era of immunotherapy and cell-based science. Truth. Facts. Living Proof.
So many of these survivor stories are old news— research 2022 updates—some are GBM patients surpassing a decade or multiple decades—miraculous …
https://www.hawaii.edu/news/2017/03/30/newirth-laker-for-a-day/
Research these facts:
Dr. Liau is backed by FDA-NIH. DCVax would not exist without the NIH funding that led to its development. NIH is today funding the DCVax doses going into patients’ arms in the Keytruda study. FDA-NIH has been backing Dr. Liau for years.
Dr. Ashkan is the chief of the clinical trials unit at Kiing’s College and Dr. Ashkan is an advisor to the U.K. government. MHRA has already demonstrated its support for the development of the DCVax platform technology and that support has only strengthened in recent months. MHRA values Dr. Ashkan’s work and supports DCVax.
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
https://newsroom.ucla.edu/releases/nih-grant-lab-gene-cell-therapies
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
https://www.bentley.edu/news/nih-funded-research-related-every-new-cancer-drug-approved-2010-2016
https://www.uclahealth.org/providers/linda-liau
https://www.kcl.ac.uk/people/keyoumars-ashkan
https://virtualtrials.org/dcvax.cfm
Dr. Liau has been the Principal Investigator on several research grants and clinical trials, and her work has been continuously funded by the National Institutes of Health (NIH) for the past 20 years.
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
https://newsroom.ucla.edu/releases/nih-grant-lab-gene-cell-therapies
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
Thank for bringing awareness to the current UCLA Keytruda—DCVax study for rGBM.
https://www.merck.com/stories/fighting-cancer-requires-an-open-mind/
Merck: “Personalized cancer vaccines which are therapeutic vaccines based on patients’ specific cancer that could potentially prime the immune system to recognize certain characteristics and attack the cancer cells”
You are correct— Dr. Liau wrote a brilliant paper in 2018 and her next big DCVax updated analysis in light of the complete data set with the advantage of more that four additional years of patients data is forthcoming.
Dr. Liau has authored over 170 peer-reviewed research articles, along with several book chapters, and a textbook entitled Brain Tumor Immunotherapy. She is on the editorial boards of several scientific/medical journals and was the Editor-in-Chief of the Journal of Neuro-Oncology (2007–2017).
She will also present at SNO:
https://soc-neuro-onc.org/
https://virtualtrials.org/dcvax.cfm
That is correct: The global DCVax P3 trial was designed and led by two world-renowned CLINICAL TRIAL EXPERTS.
Dr. Linda Liau is a world-renowned neuro-oncologist, surgeon, and educator at UCLA where she is also the chair of the department of neurosurgery. As her paper on DCVax moves through the independent peer review process, it is interesting to note that she was once the editor-in-chief of a neuro-oncology medical journal.
https://www.uclahealth.org/providers/linda-liau
Across the pond from Dr. Liau, Dr. Ashkan was the chief investigator of the DCVax trial for patients in Europe. At King’s College in London, Ashkan is the lead clinician for neuro-oncology and the chair of the King’s Neurosciences Clinical Trial Unit. He is a world-renowned cancer trial expert. A few years ago, Professor Ashkan was named the UK Clinician of the Year by The Brain Tumour Charity. Additionally, Ashkan serves as an advisor to the U.K. government.
https://www.kcl.ac.uk/people/keyoumars-ashkan
The FDA and NIH work very closely together. Highly reputable licensed professionals have vetted the immunotherapy research of Dr. Liau, I would recommend that you research and study for yourself the recent 590 million dollar grant that was awarded to UCLA. The U.S. government NIH grant is funded by tax dollars and is public record for anyone who wants to see it. Many independent physicians have reviewed the immunotherapy work of Dr. Liau. Verify it for yourself.
The NIH peer-reviewed grant is the source of funding being used today to dose patients with DCVax-L and Keytruda.
Department of Neurosurgery Chair Linda M. Liau, MD, PhD, MBA, was a leading recipient of NIH grants – No. 3 in the nation within the discipline.
“It's the stamp of approval from the NIH, because these types of grants are so rigorously peer-reviewed,” Dr. Liau says. “People get funded based on the strength of the science and that, itself, is very powerful in terms of showing that our research is scientifically valid and meaningful and hopefully will lead to future treatments.”
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
Dr. Pazdur, FDA:
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
Fact check:
These are the “types” that are posted on clinicaltrials.gov: “investigational” and “observational.” Either of these could be adaptive. To date, “adaptive” is not a distinct and separate “type” for any clinical trial in the U.S. in terms of the nature of studies as they are currently registered on the NIH clinical trial registry.
“Type”
describes the nature of a
clinical study. Study types
include interventional studies
(also called clinical trials),
and observational studies
(including patient registries)
and expanded access.
https://clinicaltrials.gov/ct2/about-studies/learn
https://virtualtrials.org/dcvax.cfm
Thank you for again highlighting the exemplary trial design—compassionate, clinically appropriate, adaptive, and representative of DCVax as an innovative new platform technology.
The trial design and its endpoints were approved by regulators multiple times. Each country or union of nations has its own RA—Canada, Germany, U.S. and the union of nations U.K. all have RAs. Each approval was a separate and distinct RA approval.
Beyond approval by multiple RAs, the trial design was approved multiple times by the FDA—the crossover design, for example, was approved twice by FDA because there was a trial halt, and then the trial was approved to resume with the same crossover design it previously had.
The MHRA in U.K. approved the trial design and its endpoints twice—once for the adult trial and now again for the pediatric trials:
On August 17, the Company received final approval of the Pediatric Investigation Plan (PIP) from the MHRA. The final regulatory approval of the PIP must be obtained before a sponsor may submit a Marketing Authorization Application (MAA) for approval to commercialize the new medicine for adult patients. The Company’s approved PIP includes a deferral under which the pediatric trials are anticipated to be undertaken after an MAA application has been submitted.
Patients will be treated with DCVax-L on the same treatment schedule as in the Company’s Phase III trial in adult glioblastoma patients.
The primary endpoint for each of the 2 pediatric trials will be overall survival, determined by comparing the survival of DCVax-L treated patients to matched contemporaneous external controls. The external controls will be identified using the same methodology as was used to pre-specify the external controls in the Statistical Analysis Plan for the Company’s Phase III trial in adult patients.
https://virtualtrials.org/dcvax.cfm
https://www.kcl.ac.uk/people/keyoumars-ashkan
https://nwbio.com/press-releases/
Your postings are very repetitive, but I love to read them. Your postings are very repetitive, but I love to read them.
This particular posting reminds me of a few fun facts:
Dr. Linda Liau is a world-renowned neuro-oncologist, surgeon, and educator at UCLA where she is also the chair of the department of neurosurgery. As her paper on DCVax moves through the independent peer review process, it is interesting to note that she was once the editor-in-chief of a neuro-oncology medical journal.
https://www.uclahealth.org/providers/linda-liau
Across the pond from Dr. Liau, Dr. Ashkan was the chief investigator of the DCVax trial for patients in Europe. At King’s College in London, Ashkan is the lead clinician for neuro-oncology and the chair of the King’s Neurosciences Clinical Trial Unit. He is a world-renowned cancer trial expert. A few years ago, Professor Ashkan was named the UK Clinician of the Year by The Brain Tumour Charity. Additionally, Ashkan serves as an advisor to the U.K. government.
https://www.kcl.ac.uk/people/keyoumars-ashkan
Thank you for reminding us of these relevant facts!
Thank you repeating this important point once again. There is a lot of confusion about OS vs PFS and your repetitive posts present the opportunity to clear up the facts. OS is the gold standard.
Please research to verify for yourself that PFS is a surrogate for OS and only used because its data is accessible sooner than OS. When and if OS is reached, OS data either confirms or disproves the accuracy of PFS as a surrogate and as a PREDICTOR of survival. OS naturally became a “hard endpoint” for the P3 as the trial spanned so many years.
“OS is the "gold standard" for measuring the clinical benefits of a cancer drug. The global trial has also reached the secondary endpoint of OS in recurrent GBM with statistical significance.”
“The ultimate goal of all oncology drugs is to improve patient-centered endpoints. These 'hard' endpoints, which are intrinsically valuable to patients, are increased overall survival (OS), improved quality of life (QoL), or both. However, by many drugs are approved or used based solely on their ability to improve surrogate endpoints; outcomes that are not inherently meaningful, but aim to predict hard outcomes.”
“In oncology, the most commonly used surrogates are response rate; a set of criteria characterizing tumor shrinkage; and time to event endpoints, such as progression-free survival (PFS)”
Overall survival is the gold standard and remains the definitive end point in cancer clinical trials.
Quite simply:
You cannot mistake
the dead for the living.
That is why OS is the
gold standard
https://virtualtrials.org/dcvax.cfm
https://www.kcl.ac.uk/people/keyoumars-ashkan
https://soc-neuro-onc.org/
https://doi.org/10.3171/2020.12.FOCUS20954
https://virtualtrials.org/dcvax.cfm
https://www.kcl.ac.uk/people/keyoumars-ashkan
https://soc-neuro-onc.org/
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
https://www.societyns.org/about/research-detail/linda-m-liau-md-phd-mba-faans-chair
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
https://nwbio.com/press-releases/
https://www.liverpool.ac.uk/systems-molecular-and-integrative-biology/staff/michael-jenkinson/
The rGBM data are significant and a real breakthrough … Considering that there is absolutely nothing that extends survival for rGBM, DCVax is a miracle. Beyond doubling rGBM survival, it is safe and does not cause debilitating side effects. From a tax payer’s point of view, it is clear that the FDA and NIH are largely responsible for the development of DCVax … and from a common sense point of view, any rGBM patient would be outraged if told that this technology could not be approved for rGBM.
Who would not want DCVax at recurrence?
DCVax is a gem for rGBM, but rGBM is just the tip of the iceberg with this platform technology as cell science is certainly not limited to only one type of tumor.
"When we make a decision about approving a drug, it has to be patient centered. It can't be about the regulations"
—Richard Pazdur, MD
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
https://virtualtrials.org/dcvax.cfm
Have you ever thought about this:
FDA / NIH work to create drugs and then FDA approves them.
NIH dollars sure seem to always find their way to Dr. Liau’s research and to DCVax. NIH and Merck are funding the Keytruda study right now.
Dr. Liau has been the Principal Investigator on several research grants and clinical trials, and her work has been continuously funded by the National Institutes of Health (NIH) for the past 20 years.
“It's the stamp of approval from the NIH, because these types of grants are so rigorously peer-reviewed,” Dr. Liau says. “People get funded based on the strength of the science and that, itself, is very powerful in terms of showing that our research is scientifically valid and meaningful …”
https://www.bentley.edu/news/nih-funded-research-related-every-new-cancer-drug-approved-2010-2016
https://newsroom.ucla.edu/releases/nih-grant-lab-gene-cell-therapies
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
Thought provoking… Considering that there is absolutely nothing that extends survival for rGBM, DCVax is a miracle. Beyond doubling rGBM survival, it is safe and does not cause debilitating side effects. From a tax payer’s point of view, it is clear that the FDA and NIH are largely responsible for the development of DCVax … and from a common sense point of view, any rGBM patient would be outraged if told that this technology could not be approved for rGBM.
Who would not want DCVax at recurrence?
DCVax is a gem for rGBM, but rGBM is just the tip of the iceberg with this platform technology as cell science is certainly not limited to only one type of tumor.
"When we make a decision about approving a drug, it has to be patient centered. It can't be about the regulations"
—Richard Pazdur, MD
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
https://virtualtrials.org/dcvax.cfm
Thank you for highlighting the most astonishing discovery of the DCVax P3—doubling rGBM survival. In fact, it was this discovery that prompted the Keytruda DCVax combo trial funded by NIH and Merck. GBM always becomes rGBM of course, so this discovery is of immeasurable significance.
RECURRENT GBM:
mOS: 13.2 mos vs. 7.8 mos from recurrence
Survival Tail: 20.7% vs. 9.6% at 24 mos after recurrence 11.1% vs. 5.1% at 30 mos after recurrence
https://virtualtrials.org/dcvax/dcvax.pdf
That is correct— the survival for recurrent GBM was the most stellar of all the data. Dr. Stupp developed the SOC and he admits that nothing works for recurrent. Watch the Dr. Stupp video and hear his own words. Dr. Stupp asserts that rGBM is a “major unmet need” (minute 13:35). He highlights that no SOC treatment works for recurrent and that survival is always the same with current therapies (14:36).
“The final data only was released two months ago, so I had the pleasure of presenting this for the first time at the British Neuro-Oncology Society meeting in Liverpool in June. So, this is really straight hot off the press. The paper has been submitted. Keeping our fingers [fingers crossed gesture] for the reviewers, so hopefully this will be published before long.”
He gave the same presentation in June and he was referring to the forthcoming peer-reviewed journal publication.
Thank you for highlighting this aspect of the P3 that is often misunderstood. The FDA, the P3 investigators, and others have recently spoken on this topic.
“Crossover was necessary for feasibility and ethical reasons:
—Necessary for enrollment and retention of patients in an era when immune therapies are not yet generally viewed as promising for cancer
—Important to justify all patients undergoing invasive leukapheresis procedure
—No benefit to placebo patients unless they could receive their autologous product made from the leukapheresis”
"Often, novel agents are so obviously superior to standard of care that no patient would participate in a randomized trial knowing that somebody else might get the experimental drug”—Richard Pazdur, MD
Richard Pazdur, M.D. is the director of the FDA's
Oncology Center of Excellence (OCE), which
leverages the combined skills of the FDA's
regulatory scientists and reviewers with expertise in
drugs, biologics and devices to expedite the
development of novel cancer products. In his role as
director of the OCE, Pazdur is responsible for
leading the effort to develop and execute an
integrated regulatory approach to enhance the
cross-center coordination of oncology product
clinical review.
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
https://www.merck.com/stories/fighting-cancer-requires-an-open-mind/
Merck: “Personalized cancer vaccines which are therapeutic vaccines based on patients’ specific cancer that could potentially prime the immune system to recognize certain characteristics and attack the cancer cells”
That is correct—OS is the gold standard.
Anyone can research to verify that PFS is a surrogate for OS and only used because its data is accessible sooner than OS. When and if OS is reached, OS data either confirms or disproves the accuracy of PFS as a surrogate and as a PREDICTOR of survival. OS naturally became a “hard endpoint” for the P3 as the trial spanned so many years.
“OS is the "gold standard" for measuring the clinical benefits of a cancer drug. The global trial has also reached the secondary endpoint of OS in recurrent GBM with statistical significance.”
“The ultimate goal of all oncology drugs is to improve patient-centered endpoints. These 'hard' endpoints, which are intrinsically valuable to patients, are increased overall survival (OS), improved quality of life (QoL), or both. However, by many drugs are approved or used based solely on their ability to improve surrogate endpoints; outcomes that are not inherently meaningful, but aim to predict hard outcomes.”
“In oncology, the most commonly used surrogates are response rate; a set of criteria characterizing tumor shrinkage; and time to event endpoints, such as progression-free survival (PFS)”
Overall survival is the gold standard and remains the definitive end point in cancer clinical trials.
Quite simply:
You cannot mistake
the dead for the living.
That is why OS is the
gold standard.
The FDA and NIH work very closely together. Highly reputable licensed professionals have vetted the immunotherapy research of Dr. Liau, I would recommend that you research and study for yourself the recent 590 million dollar grant that was awarded to UCLA. The U.S. government NIH grant is funded by tax dollars and is public record for anyone who wants to see it. Many independent physicians have reviewed the immunotherapy work of Dr. Liau. Verify it for yourself.
The NIH peer-reviewed grant is the source of funding being used today to dose patients with DCVax-L and Keytruda.
Department of Neurosurgery Chair Linda M. Liau, MD, PhD, MBA, was a leading recipient of NIH grants – No. 3 in the nation within the discipline.
“It's the stamp of approval from the NIH, because these types of grants are so rigorously peer-reviewed,” Dr. Liau says. “People get funded based on the strength of the science and that, itself, is very powerful in terms of showing that our research is scientifically valid and meaningful and hopefully will lead to future treatments.”
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
Dr. Pazdur, FDA:
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
Your posting reminds me of a few fun facts:
Dr. Linda Liau is a world-renowned neuro-oncologist, surgeon, and educator at UCLA where she is also the chair of the department of neurosurgery. As her paper on DCVax moves through the independent peer review process, it is interesting to note that she was once the editor-in-chief of a neuro-oncology medical journal.
https://www.uclahealth.org/providers/linda-liau
Across the pond from Dr. Liau, Dr. Ashkan was the chief investigator of the DCVax trial for patients in Europe. At King’s College in London, Ashkan is the lead clinician for neuro-oncology and the chair of the King’s Neurosciences Clinical Trial Unit. He is a world-renowned cancer trial expert. A few years ago, Professor Ashkan was named the UK Clinician of the Year by The Brain Tumour Charity. Additionally, Ashkan serves as an advisor to the U.K. government.
https://www.kcl.ac.uk/people/keyoumars-ashkan
Thank you for reminding us of these relevant facts!
Yes, thank you—the trial was a brilliant success and the independent peer review is forthcoming.
Most recent news and events:
Thank you for reminding us of all the publicity available evidence of the FDA’s likely support of DCVax and other emerging immunotherapy technologies.
The FDA approved the trial to commence, approved the trial to resume after its halt years ago, and the trial was successfully completed at 94 sites worldwide.
There is evidence that the FDA does and will have a favorable view of the DCVax P3, and no evidence to the contrary.
The FDA director said:
"Now we are in the era of immunotherapy"
-Richard Pazdur, MD
"Often, novel agents are so obviously superior to standard of care that no patient would participate in a randomized trial knowing that somebody else might get the experimental drug
-Richard Pazdur, MD
"There's also been a revolution in tumor immunology. Before, in my early career, tumor immunology was looked at kind of as black magic, as witchcraft. Now it's accepted."
-Richard Pazdur, MD
"When we make a decision about approving a drug, it has to be patient centered. It can't be about the
regulations"
-Richard Pazdur, MD
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
Fact check: The FDA and NIH work very closely together. Highly reputable licensed professionals have vetted the immunotherapy research of Dr. Liau, I would recommend that you research and study for yourself the recent 590 million dollar grant that was awarded to UCLA. The U.S. government NIH grant is funded by tax dollars and is public record for anyone who wants to see it. Within its many many pages, you will find many professionals who have reviewed the immunotherapy work of Dr. Liau. Verify it for yourself.
The NIH peer-reviewed grant is the source of funding being used today to dose patients with DCVax-L and Keytruda.
clinicaltrials.gov/...
Department of Neurosurgery Chair Linda M. Liau, MD, PhD, MBA, was a leading recipient of NIH grants – No. 3 in the nation within the discipline.
“It's the stamp of approval from the NIH, because these types of grants are so rigorously peer-reviewed,” Dr. Liau says. “People get funded based on the strength of the science and that, itself, is very powerful in terms of showing that our research is scientifically valid and meaningful and hopefully will lead to future treatments.”
So once again—the NIH for example, is a much better source than I am or that anyone on social media is or anyone on a stock message board. Researching the peer review of a large recent government grant is an example of research that is more reliable than a stock message board is. Anyone can go look at the grant for themselves and review the professional vetting of its recipients.
NIH and the FDA tell us that they are well-coordinated they assert that work closely together on the development of new technologies.
connect.uclahealth.org/...
Thank you for again highlighting the exemplary trial design—compassionate, clinically appropriate, adaptive, and representative of DCVax as an innovative new platform technology.
The trial design and its endpoints were approved by regulators multiple times. Each country or union of nations has its own RA—Canada, Germany, U.S. and the union of nations U.K. all have RAs. Each approval was a separate and distinct RA approval.
Beyond approval by multiple RAs, the trial design was approved multiple times by the FDA—the crossover design, for example, was approved twice by FDA because there was a trial halt, and then the trial was approved to resume with the same crossover design it previously had.
The MHRA in U.K. approved the trial design and its endpoints twice—once for the adult trial and now again for the pediatric trials:
On August 17, the Company received final approval of the Pediatric Investigation Plan (PIP) from the MHRA. The final regulatory approval of the PIP must be obtained before a sponsor may submit a Marketing Authorization Application (MAA) for approval to commercialize the new medicine for adult patients. The Company’s approved PIP includes a deferral under which the pediatric trials are anticipated to be undertaken after an MAA application has been submitted.
Patients will be treated with DCVax-L on the same treatment schedule as in the Company’s Phase III trial in adult glioblastoma patients.
The primary endpoint for each of the 2 pediatric trials will be overall survival, determined by comparing the survival of DCVax-L treated patients to matched contemporaneous external controls. The external controls will be identified using the same methodology as was used to pre-specify the external controls in the Statistical Analysis Plan for the Company’s Phase III trial in adult patients.
https://virtualtrials.org/dcvax.cfm
https://www.kcl.ac.uk/people/keyoumars-ashkan
https://nwbio.com/press-releases/
You are correct— the P3 was a successful pivotal trial. Dr. Ashkan at King’s College is the “Lead Clinician for Neuro-Oncology and the Chair of King’s Neurosciences Clinical Trial Unit.” Here is the world-renowned clinical trial expert Dr. Ashkan yesterday:
Yes, Dr. Ashkan is a world-renowned clinical trial expert and an advisor to the U.K. government. His association with the DCVax P3 is extraordinarily meaningful.
https://www.kcl.ac.uk/people/keyoumars-ashkan
https://virtualtrials.org/dcvax.cfm
You are correct. OS is the gold standard.
The endpoints and study design have been approved by regulators. The approval was recently reaffirmed as legitimate and clinically appropriate:
On August 17, the Company received final approval of the Pediatric Investigation Plan (PIP) from the MHRA. The final regulatory approval of the PIP must be obtained before a sponsor may submit a Marketing Authorization Application (MAA) for approval to commercialize the new medicine for adult patients. The Company’s approved PIP includes a deferral under which the pediatric trials are anticipated to be undertaken after an MAA application has been submitted.
Patients will be treated with DCVax-L on the same treatment schedule as in the Company’s Phase III trial in adult glioblastoma patients.
The primary endpoint for each of the 2 pediatric trials will be overall survival, determined by comparing the survival of DCVax-L treated patients to matched contemporaneous external controls. The external controls will be identified using the same methodology as was used to pre-specify the external controls in the Statistical Analysis Plan for the Company’s Phase III trial in adult patients.
https://virtualtrials.org/dcvax.cfm
You are correct. The FDA approved the trial to continue to its conclusion and it finally was completed after many years of challenges and long-living trial participants.
https://virtualtrials.org/dcvax.cfm
Yes, I think you’re correct to highlight the confusion, misinformation, and disinformation that is used by stock shorts to muddy the waters. The most recent trial information is posted here:
https://virtualtrials.org/dcvax.cfm
Anyone can research the original FDA approved design that allowed crossover. FDA knew from the start that the placebo patients might all crossover, and the FDA approved the trial to proceed with a crossover design. Thinking logically, why should we now assume that FDA will have a problem with the crossover?
Anyone can research to verify that PFS is a surrogate for OS and only used because its data is accessible sooner than OS. When and if OS is reached, OS data either confirms or disproves the accuracy of PFS as a surrogate and as a PREDICTOR of survival. Furthermore, OS was always an endpoint along with PFS.
Statistical analysis accounts for all factors. A peer review is forthcoming and there will also be an FDA advisory analysis.
The MHRA in U.K. approved the trial design and its endpoints twice—once for the adult trial and now again for the pediatric trials:
On August 17, the Company received final approval of the Pediatric Investigation Plan (PIP) from the MHRA. The final regulatory approval of the PIP must be obtained before a sponsor may submit a Marketing Authorization Application (MAA) for approval to commercialize the new medicine for adult patients. The Company’s approved PIP includes a deferral under which the pediatric trials are anticipated to be undertaken after an MAA application has been submitted.
Patients will be treated with DCVax-L on the same treatment schedule as in the Company’s Phase III trial in adult glioblastoma patients.
The primary endpoint for each of the 2 pediatric trials will be overall survival, determined by comparing the survival of DCVax-L treated patients to matched contemporaneous external controls. The external controls will be identified using the same methodology as was used to pre-specify the external controls in the Statistical Analysis Plan for the Company’s Phase III trial in adult patients.
The pediatric approval is full approval and immediately actionable. There is no requirement for adult approval or any prior application for adult approval for the pediatric trials to commence, however, the company has indicated that they will submit an application for adult commercial approval first. The second approval of the same trial design bodes well for the forthcoming adult application.
Verify facts. Seek truth and credible sources.
Yes, that is correct. The FDA did in fact approve the trial to resume and it was successfully completed.
You linked me to an accurate trial summary. The excerpt pasted below captures what I think you’re trying to say:
According to overall results, the 331-patient trial
has met the primary endpoint of overall survival
(OS) in newly diagnosed GBM patients after the
progression-free survival (PFS) the initial primary
endpoint of the trial, was found to be unviable.
OS is the "gold standard" for measuring the
clinical benefits of a cancer drug.
The global trial has also reached the secondary
endpoint of OS in recurrent GBM with statistical
significance.
OS is the "gold standard" for measuring the
clinical benefits of a cancer drug.
The global trial has also reached the secondary
endpoint of OS in recurrent GBM with statistical
significance.
In terms of safety, there were five instances of
serious adverse events after the administration
of 2.193 doses of DCVax-L. There were no
reports of autoimmune reactions or incidences
of cytokine storm, according to the presentation.
https://virtualtrials.org/dcvax.cfm
I think I know what you mean in reference to the FDA . The FDA approved the trial to resume in full force after its halt.
The FDA and NIH work very closely together. Highly reputable licensed professionals have vetted the immunotherapy research of Dr. Liau, I would recommend that you research and study for yourself the recent 590 million dollar grant that was awarded to UCLA. The U.S. government NIH grant is funded by tax dollars and is public record for anyone who wants to see it. Within its many many pages, you will find many professionals who have reviewed the immunotherapy work of Dr. Liau.
The NIH peer-reviewed grant is the source of funding being used today to dose patients with DCVax-L and Keytruda.
https://clinicaltrials.gov/ct2/show/NCT04201873
Department of Neurosurgery Chair Linda M. Liau, MD, PhD, MBA, was a leading recipient of NIH grants – No. 3 in the nation within the discipline.
“It's the stamp of approval from the NIH, because these types of grants are so rigorously peer-reviewed,” Dr. Liau says. “People get funded based on the strength of the science and that, itself, is very powerful in terms of showing that our research is scientifically valid and meaningful and hopefully will lead to future treatments.”
The NIH is a much better source than I am or that anyone on social media is or anyone on a stock message board. Researching the peer review of a large recent government grant is an example of research that is more reliable than a stock message board is. Anyone can go look at the grant for themselves and review the professional vetting of its recipients.
NIH and the FDA tell us that they are well-coordinated they assert that work closely together on the development of new technologies.
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
That is correct —I understand what you’re trying to say and I agree—The trial design and its endpoints were approved by regulators multiple times. Each country or union of nations has its own RA—Canada, Germany, U.S. and the union of nations U.K. all have RAs. Each approval was a separate and distinct RA approval.
Beyond approval by multiple RAs, the trial design was approved multiple times by the FDA—the crossover design, for example, was approved twice by FDA because there was a trial halt, and then the trial was approved to resume with the same crossover design it previously had.
The MHRA in U.K. approved the trial design and its endpoints twice—once for the adult trial and now again for the pediatric trials:
On August 17, the Company received final approval of the Pediatric Investigation Plan (PIP) from the MHRA. The final regulatory approval of the PIP must be obtained before a sponsor may submit a Marketing Authorization Application (MAA) for approval to commercialize the new medicine for adult patients. The Company’s approved PIP includes a deferral under which the pediatric trials are anticipated to be undertaken after an MAA application has been submitted.
Patients will be treated with DCVax-L on the same treatment schedule as in the Company’s Phase III trial in adult glioblastoma patients.
The primary endpoint for each of the 2 pediatric trials will be overall survival, determined by comparing the survival of DCVax-L treated patients to matched contemporaneous external controls. The external controls will be identified using the same methodology as was used to pre-specify the external controls in the Statistical Analysis Plan for the Company’s Phase III trial in adult patients.
The pediatric approval is full approval and immediately actionable. There is no requirement for adult approval or any prior application for adult approval for the pediatric trials to commence, however, the company has indicated that they will submit an application for adult commercial approval first. The second approval of the same trial design bodes well for the forthcoming adult application.
https://virtualtrials.org/dcvax.cfm