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learningcurve2020, This study found that autologous tumor lystate-loaded dendritic cell vaccination plus standard of care (SOC) was associated with improved survival in both newly diagnosed & recurrent glioblastoma compared with matched controls who received SOC treatment. https://t.co/Uso7Pkh1Kt Our team just met with the @NorthwestBio team to learn about #DCVax and had the pleasure of speaking with longterm DCVax patients. An honor and a privilege. #endbraincancer #sno2023 pic.twitter.com/dw3X76DBru
I tried to read your 20 posts today, but you’re only reposting random bs and you’re really not making much sense. I believe that you’re drifting off way too far from Earth 🌎️ … It sounds like you’re misinformed and need better sources of information. It is advisable to seek full-context credible sources and consult licensed oncologists.
Amid all of the misinformation and bad-faith disinformation pollution online, it is crucial that we refocus our attention beyond baseless social media posts to consider better sources…
For a reliable appraisal of the DCVax-L P3 trial, its design, and the significance of the resulting survival data, it is advisable to refer to the analyses of qualified physicians. One such analysis can be found on the JAMA Oncology website where the link to the independent peer review and supplementary materials are published.
JAMA Oncology is a peer-reviewed medical journal that is part of the Journal of the American Medical Association (JAMA) network, which is one of the most widely respected and influential medical journal publishers globally.
Being a peer-reviewed journal means that research articles submitted to JAMA Oncology undergo a thorough evaluation process by independent experts in the field before they are accepted for publication. This process helps ensure the quality, validity, and scientific rigor of the research presented in the journal.
Researchers and other professionals in the medical community rely on publications like JAMA Oncology for up-to-date and credible information in the field of oncology.
https://ceoworld.biz/2022/04/05/top-5-medical-journals-in-the-world-everyone-should-know-about/
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html
https://www.jci.org/articles/view/169314
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://hotb.org/wp-content/uploads/2022/05/spore-article-for-donors-4.18.22.pdf
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
LC,
DCVax-L needs to reach patients worldwide—I agree 100% … NWBO needs regulatory approval(s) to achieve that objective.
Just as the independent peer review process required a lot of groundwork, preparation, and coordination, the MAA does as well. NWBO is a small pre-commercial biotech. The executive team includes well-educated and experienced leaders whose business acumen is formidable. They have enlisted the support of consultants to ensure that regulatory applications are complete, accurate, and fully compliant with filing guidelines.
Your suggestion of using AI to research and supplement responses to discussion topics online was a good idea! Here is some further commentary from an AI app about the importance of having filing support:
“A Marketing Authorization Application (MAA) filing with the Medicines and Healthcare products Regulatory Agency (MHRA) or any regulatory agency involves submitting comprehensive documentation to gain approval for marketing a medicinal product. Both a publisher and a quality control team play crucial roles in ensuring the success and compliance of the MAA filing. Here's why:
1. **Complexity of Documentation:**
- MAA submissions are highly complex and involve a vast amount of documentation, including clinical trial data, manufacturing processes, quality control measures, safety data, and more. A dedicated publisher helps organize, format, and compile these documents into a coherent and compliant submission.
2. **Regulatory Compliance:**
- Regulatory agencies like the MHRA have strict requirements regarding the format, structure, and content of submissions. A skilled publisher ensures that the MAA complies with these regulatory guidelines, increasing the likelihood of acceptance and speeding up the regulatory review process.
3. **Accuracy and Consistency:**
- Quality control teams are crucial for ensuring the accuracy and consistency of the information presented in the MAA. Any inconsistencies, errors, or inaccuracies could lead to delays in the review process or rejection of the application.
4. **Adherence to Standards:**
- Quality control teams ensure that the submission adheres to the highest quality and data integrity standards. This is particularly important for critical sections such as clinical trial data and manufacturing processes, where precision and reliability are paramount.
5. **Risk Mitigation:**
- Thorough quality control processes help mitigate the risk of regulatory issues or deficiencies. Identifying and addressing potential problems before submission increases the chances of a successful review and approval.
6. **Efficient Communication:**
- A well-organized submission facilitated by a publisher enables efficient communication between the applicant and the regulatory agency. Clear and organized documentation helps regulatory reviewers navigate the submission, leading to more effective communication and a smoother review process.
In summary, the collaboration of a skilled publisher and a robust quality control team is essential for preparing a high-quality, compliant MAA filing with the MHRA. This collaborative effort increases the chances of a successful regulatory review and approval, allowing the medicinal product to be marketed and distributed to patients.”
—ChatGPT
https://www.prnewswire.com/news-releases/northwest-biotherapeutics-provides-update-on-final-preparations-for-marketing-authorization-application-301995932.html
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html
Yes! “Long term” effects! That’s an awesome point! Anything “long term” would be a very welcome side effect!
https://www.theguardian.com/science/2022/nov/17/im-just-carrying-on-vaccine-gives-brain-cancer-patient-years-of-extra-life
LC,
Thanks for the prediction, but it is advisable to consult financial professionals and licensed oncologists while avoiding message board disinformation and baseless innuendo.
Thanks also for suggesting that we utilize AI —not a bad idea… I thought I would try an AI app in reference to the NWBO conversation:
"Short and distort refers to a manipulative practice in financial markets. It involves individuals or entities taking short positions in a stock (betting that its price will fall) and then spreading false or misleading information about the company on stock message boards or other media platforms. The goal is to drive down the stock price, allowing those behind the scheme to profit from their short positions.
This unethical tactic can harm investors, create market volatility based on false information, and potentially damage the reputation of the targeted company. Securities regulators actively monitor and investigate such activities to maintain the integrity of financial markets.” —ChatGPT
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
aesop1,
You’re slipping way too far off track—try to refocus and come back to 🌎
https://braintumourresearch.org/en-us/blogs/research-campaigning-news/astonishing-results-for-brain-tumour-vaccine-trial
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
Combo is King!
https://clinicaltrials.gov/study/NCT04201873
iclight, This study found that autologous tumor lystate-loaded dendritic cell vaccination plus standard of care (SOC) was associated with improved survival in both newly diagnosed & recurrent glioblastoma compared with matched controls who received SOC treatment. https://t.co/Uso7Pkh1Kt Our team just met with the @NorthwestBio team to learn about #DCVax and had the pleasure of speaking with longterm DCVax patients. An honor and a privilege. #endbraincancer #sno2023 pic.twitter.com/dw3X76DBru
I believe that you’re drifting off way too far from Earth 🌎️ … It sounds like you’re misinformed and need better sources of information. It is advisable to seek full-context credible sources and consult licensed oncologists.
Amid all of the misinformation and bad-faith disinformation pollution online, it is crucial that we refocus our attention beyond baseless social media posts to consider better sources…
For a reliable appraisal of the DCVax-L P3 trial, its design, and the significance of the resulting survival data, it is advisable to refer to the analyses of qualified physicians. One such analysis can be found on the JAMA Oncology website where the link to the independent peer review and supplementary materials are published.
JAMA Oncology is a peer-reviewed medical journal that is part of the Journal of the American Medical Association (JAMA) network, which is one of the most widely respected and influential medical journal publishers globally.
Being a peer-reviewed journal means that research articles submitted to JAMA Oncology undergo a thorough evaluation process by independent experts in the field before they are accepted for publication. This process helps ensure the quality, validity, and scientific rigor of the research presented in the journal.
Researchers and other professionals in the medical community rely on publications like JAMA Oncology for up-to-date and credible information in the field of oncology.
https://ceoworld.biz/2022/04/05/top-5-medical-journals-in-the-world-everyone-should-know-about/
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html
https://www.jci.org/articles/view/169314
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://hotb.org/wp-content/uploads/2022/05/spore-article-for-donors-4.18.22.pdf
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
Fact ✅
I don’t know anything about the doctor that you cited and I’m not commenting about him, but your assertion that he “has more than twice the publications” is verifiably false. You seem to just make stuff up and post it.
Both of these excerpts are from the exact same source—The Society of Neurological Surgeons:
“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).”
https://www.societyns.org/about/officers-detail/linda-m-liau-md-phd-mba-4
“He holds several patents on gene transfer techniques and is author or co-authors of more than 200 peer-reviewed publications. He has been elected to the American Society for Clinical Investigation (ASCI), is a fellow of the American Association for the Advancement of Science (AAAS), and a member of the American Academy of Neurosurgery.”
https://www.societyns.org/about/officers-detail/president-e-antonio-chiocca-md-phd
To clarify, you’re citing Liau’s spoken words during an oral podcast interview in conversational format.
In contrast, the printed JAMA Oncology publication was proofed for errors and is accurate.
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
LC,
Just as the independent peer review process required a lot of groundwork, preparation, and coordination, the MAA does as well.
The company has provided timeline forecasts and updates, and they have also advised us appropriately that some of the MAA work is independent of the company—this was also the circumstance while working though the independent peer review process, as you may recall.
NWBO is a small pre-commercial biotech. The executive team includes well-educated and experienced leaders whose business acumen is formidable. They have enlisted the support of consultants to ensure that regulatory applications are complete, accurate, and fully compliant with filing guidelines.
Your suggestion of using AI to research and supplement responses to discussion board topics online was a good idea! Here is some further commentary from an AI app about the importance of enlisting expert filing support:
“A Marketing Authorization Application (MAA) filing with the Medicines and Healthcare products Regulatory Agency (MHRA) or any regulatory agency involves submitting comprehensive documentation to gain approval for marketing a medicinal product. Both a publisher and a quality control team play crucial roles in ensuring the success and compliance of the MAA filing. Here's why:
1. **Complexity of Documentation:**
- MAA submissions are highly complex and involve a vast amount of documentation, including clinical trial data, manufacturing processes, quality control measures, safety data, and more. A dedicated publisher helps organize, format, and compile these documents into a coherent and compliant submission.
2. **Regulatory Compliance:**
- Regulatory agencies like the MHRA have strict requirements regarding the format, structure, and content of submissions. A skilled publisher ensures that the MAA complies with these regulatory guidelines, increasing the likelihood of acceptance and speeding up the regulatory review process.
3. **Accuracy and Consistency:**
- Quality control teams are crucial for ensuring the accuracy and consistency of the information presented in the MAA. Any inconsistencies, errors, or inaccuracies could lead to delays in the review process or rejection of the application.
4. **Adherence to Standards:**
- Quality control teams ensure that the submission adheres to the highest quality and data integrity standards. This is particularly important for critical sections such as clinical trial data and manufacturing processes, where precision and reliability are paramount.
5. **Risk Mitigation:**
- Thorough quality control processes help mitigate the risk of regulatory issues or deficiencies. Identifying and addressing potential problems before submission increases the chances of a successful review and approval.
6. **Efficient Communication:**
- A well-organized submission facilitated by a publisher enables efficient communication between the applicant and the regulatory agency. Clear and organized documentation helps regulatory reviewers navigate the submission, leading to more effective communication and a smoother review process.
In summary, the collaboration of a skilled publisher and a robust quality control team is essential for preparing a high-quality, compliant MAA filing with the MHRA. This collaborative effort increases the chances of a successful regulatory review and approval, allowing the medicinal product to be marketed and distributed to patients.”
—ChatGPT
https://www.prnewswire.com/news-releases/northwest-biotherapeutics-provides-update-on-final-preparations-for-marketing-authorization-application-301995932.html
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html
LC,
The compassionate use cases generated some astonishing data, and those data may be included in the regulatory filings!
https://t.co/082urSTQ0s
https://www.braintumourresearch.org/media/news/news-item/2022/11/18/astonishing-results-for-brain-tumour-vaccine-trial
LC’s suggestion of using AI to supplement responses to postings on message boards was actually a good idea!
“Yes, compassionate use data, also known as expanded access or named patient programs, can be included in regulatory submissions for drug approval. Compassionate use refers to the use of an investigational drug outside of a clinical trial to treat a patient with a serious or life-threatening illness for whom no other treatment options are available.
Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), recognize that compassionate use programs can provide valuable information about a drug's safety and potential efficacy. However, the inclusion of compassionate use data in regulatory submissions is subject to certain conditions:
1. **Data Quality and Relevance:**
- The compassionate use data must meet the standards of quality, relevance, and reliability expected in clinical trials. Robust data collection and reporting practices are crucial.
2. **Consistency with Regulatory Requirements:**
- The data collected under compassionate use should align with the regulatory requirements for the type of approval sought (e.g., New Drug Application, Biologics License Application).
3. **Ethical Considerations:**
- Ethical considerations surrounding patient safety and informed consent are essential. The compassionate use program should adhere to ethical standards, and patients should be well-informed about the risks and benefits.
4. **Corroboration with Controlled Clinical Trial Data:**
- While compassionate use data can be informative, regulatory agencies typically prioritize data from well-designed, controlled clinical trials. Compassionate use data may complement such trial data but is not a substitute for it.
5. **Regulatory Agency Consultation:**
- It's advisable to consult with the relevant regulatory agency early in the drug development process to discuss the potential inclusion of compassionate use data in regulatory submissions. Agencies may provide guidance on how this data can be integrated appropriately.”
—ChatGPT
LC,
Why not consider a quiet period of your own?
…Unless you have another gem💎to share 😉
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173294572
BTW, I really liked your AI suggestion! Here is a bit more from ChatGPT:
”Investors can take several steps to avoid falling victim to stock disinformation:
**Verify Information from Reliable Sources:**
- Cross-reference information from multiple reputable sources. Avoid relying solely on one channel, especially social media or anonymous message boards.
**Understand the Company:**
- Conduct thorough research on the companies you're interested in. Understand their financials, business model, and industry. Reliable information often comes from official reports, financial statements, and reputable news sources.
**Use Caution with Social Media:**
- While social media platforms can provide information, they can also be a source of misinformation. Be critical of information shared on these platforms and verify it through reliable sources.
**Stay Informed about Market Regulations:**
- Understand the regulations governing financial markets. Authorities such as the SEC (U.S. Securities and Exchange Commission) take actions against those engaged in fraudulent activities.
**Consider Professional Advice:**
- Consult with financial advisors or professionals who can provide guidance based on expertise and experience.
**Participate in Reputable Forums:**
- If you engage in online discussions, consider reputable financial forums where discussions are moderated, and misinformation is less likely to thrive.
**Be Skeptical of Unsubstantiated Claims:**
- If an investment opportunity sounds too good to be true or is based on unverifiable claims, approach it with skepticism.
By staying informed and exercising caution, investors can better protect themselves from falling prey to stock disinformation.” —ChatGPT
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173294873
LC, This study found that autologous tumor lystate-loaded dendritic cell vaccination plus standard of care (SOC) was associated with improved survival in both newly diagnosed & recurrent glioblastoma compared with matched controls who received SOC treatment. https://t.co/Uso7Pkh1Kt
Thanks for the tip! Consulting AI is not a bad idea, so I thought I would try an AI app in reference to the NWBO conversation:
"Short and distort refers to a manipulative practice in financial markets. It involves individuals or entities taking short positions in a stock (betting that its price will fall) and then spreading false or misleading information about the company on stock message boards or other media platforms. The goal is to drive down the stock price, allowing those behind the scheme to profit from their short positions.
This unethical tactic can harm investors, create market volatility based on false information, and potentially damage the reputation of the targeted company. Securities regulators actively monitor and investigate such activities to maintain the integrity of financial markets.” —ChatGPT
Perhaps consider looking beyond social media to seek trustworthy full-context sources…
For a reliable appraisal of the trial, its design, and the significance of the resulting survival data, it is advisable to refer to the analyses of qualified physicians. One such analysis can be found on the JAMA Oncology website where the link to the independent peer review and supplementary materials are published.
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html
https://www.jci.org/articles/view/169314
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://hotb.org/wp-content/uploads/2022/05/spore-article-for-donors-4.18.22.pdf
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
[color=red][/color]
iclight,
The fact that those patients were alive to have additional resections is significant. Patients who enjoy extended survival have the chance to try any number of additional medical treatments or wellness therapies.
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
LC,
Thanks for asking about the clinical data! There are safety and efficacy data beyond the P3. If you’re looking for high percentages, you might want to take a look at the PD1 combo study at UCLA!
https://clinicaltrials.gov/study/NCT04201873
Dr. Toms briefly mentions the interim survival data for the small but mighty pembrolizumab combo in this press conference. If you never saw this video before, I highly recommend watching it all the way through!
https://www.jci.org/articles/view/169314
Combo is King!
learningcurve2020,
You might consider posting less frequently and more thoughtfully. Your sophomoric approach is transparent and counterproductive to your objectives—you’re only demonstrating that the prospective value of NWBO is likely vast. The incessant random innuendo spaghetti that you throw at the wall signals value! If a sharp rise in the price were not on the horizon, you would not commit so many hours to publishing thoughtless mud on a message board throughout a holiday weekend. Thanks for the indicator!! 😉
Ironically however, you do sometimes post a real gem💎! The JCI publication set me on a path of exploration that I had previously overlooked. Now, I can appreciate more fully how the combo implications are potentially significant and game-changing. I am not an oncologist, but I find this technology fascinating as a platform…
Soon after LC posted the link to JCI, the Merck PR was published about the Daiichi Sankyo deal, and then I went back to reread the article again and I watched some videos of Dr. Liau’s discussions on the topic of combo therapy…
✅ DCVax-L is efficacious (see JAMA Oncology).
✅ DCVax-L + PD1 is perhaps far more efficacious than DCVax-L as a monotherapy (see interim survival data).
⭐️ DCVax-L technology + PD1 technology + CFS-1R technology or ADC technology could be yet another breakthrough … The P3 that was published in JAMA Oncology looks like only the tip of an enormous iceberg!
Perhaps without realizing it, I think LC may have actually dropped the mic after announcing the JCI publication!
Combo is King!
The field of cell-based therapy is evolving rapidly and the DCVax-L platform might be a key component to unlocking the efficacy of more than one class of drugs!
Thanks in part to all of LC’s posts on this message board, I have arrived at the view that each existing, emerging, or recently commercialized drug class in the field of oncology represents another potential opportunity to discover an efficacious combo with the DCVax-L platform! PD1 blockade is only one excellent example that bodes well for further successful combos.
https://www.cell.com/trends/cancer/fulltext/S2405-8033(23)00005-5
https://thehealthcaretechnologyreport.com/merck-and-daiichi-sankyo-enter-landmark-5-5-billion-partnership/
https://www.jci.org/articles/view/169314
The Nobel Prize was a harbinger of the novel DCVax-L cell-based platform technology!
https://www.livescience.com/16354-nobel-prize-medicine-2011-immune-research.html
Dr. Steinman’s work lives on at UCLA!
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
learningcurve2020, Our team just met with the @NorthwestBio team to learn about #DCVax and had the pleasure of speaking with longterm DCVax patients. An honor and a privilege. #endbraincancer #sno2023 pic.twitter.com/dw3X76DBru
You raise a valid point: The DCVax-L cell-based platform technology deserves to be celebrated and recognized for the landmark innovation that it is! I agree 100% … There are more important things for us to discuss. Did you catch Dr. Bosch’s presentation in Vancouver last week?
https://www.soc-neuro-onc.org/
learningcurve2020,
Beautiful story about Mr. Bienvenu who has not suffered a recurrence following surgery, chemo, and radiation… now six years from diagnosis! Thank you for sharing such a hopeful story!
More treatment options are on the horizon for nGBM, rGBM, and other cancers too!
A wise man once likened the accelerating speed of the evolution of cell-based immunotherapy technology to the speed of chocolates on Lucy’s conveyor belt! I quite agree!
Each existing, emerging, or recently commercialized drug class in the field of oncology represents another potential opportunity to discover an efficacious combo with the DCVax-L platform!
Combo is King!
https://www.fda.gov/drugs/news-events-human-drugs/50-years-progress-treating-patients-cancer
https://www.jci.org/articles/view/169314
https://clinicaltrials.gov/study/NCT04201873
Wow—thanks!
I have been so focused on the amazing interim data from the DCVax-L PD-1 combo study at UCLA that I have not paid much attention to all of the other emerging possibilities …
The JCI article was enlightening, and then the Daiichi Sankyo news was intriguing as well!
Around the time that the DCVax-L P3 JAMA peer review was published, I had never heard of CSF-1R inhibitors or ADCs.
The field of cell-based therapy is evolving rapidly and the DCVax-L platform might be a key component for unlocking the efficacy of more than one class of drugs.
Adding CSF-1R to PD-1 blockade and DCVax-L is a combo that UCLA plans to study with the support of the NIH, and Merck seems to be on the cutting edge with their recently announced landmark partnership with Daiichi Sankyo. I would love to see Dr. Liau and Northwest Bio partner with Merck—the pembrolizumab combo study interim results bode well for the possibility of other efficacious combos with DCVax-L as a platform technology.
https://www.cell.com/trends/cancer/fulltext/S2405-8033(23)00005-5
https://www.jci.org/articles/view/169314
Replying to myself to expand on the topic of combo therapies…
Just to clarify: I did not mean to suggest that pexidartinib (PLX3397) is an ADC. CSF-1R inhibitors and Antibody Drug Conjugates (ADCs) are distinct types of therapies.
I’m just beginning to research this topic and I am interested in learning more about the potential for combining DCVax-L with other immunotherapy agents beyond only PD-1 blockade. The Merck deal with Daiichi Sankyo has cast some light on fascinating new possibilities…
From my research:
“CSF-1R inhibitors target the Colony-Stimulating Factor 1 Receptor, often involved in regulating the immune system. On the other hand, ADCs are a type of targeted therapy that combines an antibody with a drug payload.”
https://www.daiichisankyo.com/products/
LC,
Have you considered trying a quiet period yourself?
… Unless you have more gems to share 💎😉
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173289965
learningcurve2020,
Yes! JCI was a ⭐️GOLDEN mic drop!
https://www.jci.org/articles/view/169314
Thanks for posting the link to JCI! Sometimes the message board is worth reading!
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173289965
Well folks, as shocking as it may be, I have LC to thank for linking me to the JCI publication… Now, I can appreciate more fully how the combo implications are potentially vast and game-changing … I am not an oncologist, but I find this technology fascinating as a platform…
Soon after LC posted the link to JCI, the Merck PR was published about the ADC deal, and then I went back to reread the article again and I watched some videos of Dr. Liau’s discussions on the topic of combo therapy..
✅ DCVax-L is efficacious (see JAMA Oncology).
✅ DCVax-L + PD1 is perhaps far more efficacious than DCVax-L as a monotherapy (see interim survival data).
⭐️ DCVax-L technology + PD1 technology + ADC technology could be yet another breakthrough … The P3 that was published in JAMA Oncology looks like only the tip of an enormous iceberg!
Perhaps without realizing it, I think LC may have actually dropped the mic after announcing the JCI publication!
Combo is King!
https://www.cell.com/trends/cancer/fulltext/S2405-8033(23)00005-5
https://thehealthcaretechnologyreport.com/merck-and-daiichi-sankyo-enter-landmark-5-5-billion-partnership/
https://www.jci.org/articles/view/169314
The Nobel Prize was a harbinger of the novel DCVax-L cell-based platform technology!
https://www.livescience.com/16354-nobel-prize-medicine-2011-immune-research.html
Dr. Steinman’s work lives on at UCLA!
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
HyGro, Explore Professor Keyoumars Ashkan's passion for neurosurgery and his love for @KingsCollegeNHS below as part of their #BrilliantPeople series🧠👇@KingsNeuro @KingsIoPPN https://t.co/yGKt2681Ie
Thanks for reposting your views about the P3 again…
More importantly, thank you for highlighting the FDA and the NIH and the SPORE at UCLA! We are now in the era of RWD and immunotherapy!
Exciting times … Combo is King!
https://www.raps.org/news-and-articles/news-articles/2023/8/fda-finalizes-guidance-on-real-world-evidence-in-d
https://www.raps.org/News-and-Articles/News-Articles/2023/9/FDA%E2%80%99s-Califf-Expect-to-see-more-RWE-based-regulato
https://www.fda.gov/media/171667/download
Professor Ashkan is a careful and precise brain surgeon—listen to his words.
Skip to timestamp 13:00 of the ASCO video to hear about the SAP.
https://www.kch.nhs.uk/news/kings-team-wins-professional-excellence-award/
https://www.uclahealth.org/cancer/researchers/spores/ucla-spore-brain-cancer/research-projects
The interim PD1 combo data are brilliant, and the trial is significant for a number of reasons relating to FDA guidelines and NIH peer-reviewed grant funding. In this combo trial, patients who receive DCVax-L + placebo are being compared to patients who receive DCVax-L + pembrolizumab.
https://clinicaltrials.gov/ct2/show/NCT04201873
https://www.merck.com/news/daiichi-sankyo-and-merck-announce-global-development-and-commercialization-collaboration-for-three-daiichi-sankyo-dxd-adcs/
https://www.jci.org/articles/view/169314
https://hotb.org/wp-content/uploads/2022/05/spore-article-for-donors-4.18.22.pdf
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
The U.S. NIH has supported the DCVax-L platform for years, and the NIH renewed its support in 2022 to continue to fund the development of this technology and to fund research into combination therapies.
NIH-funded DCVax-L research is ongoing at UCLA today.
NIH grants are peer-reviewed and the research that NIH funds is highly scrutinized in advance of the award and also intermittently for the term of the various research projects.
https://www.bentley.edu/news/new-study-shows-nih-investment-new-drug-approvals-comparable-investment-pharmaceutical
https://www.bentley.edu/news/nih-funded-research-related-every-new-cancer-drug-approved-2010-2016
https://ashpublications.org/ashclinicalnews/news/3819/NIH-Funding-Tied-to-FDA-Approval-of-210-Drugs
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
https://www.uclahealth.org/news/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
https://www.fda.gov/drugs/news-events-human-drugs/50-years-progress-treating-patients-cancer
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
learningcurve2020,
Please post full-context links so that everyone can verify your vague citations for themselves.
Here is the PR that you cited:
https://nwbio.com/northwest-biotherapeutics-provides-update-on-near-term-plans-for-submission-of-marketing-authorization-application-2/
Please post the article that you mentioned.
You linked us to the JCI article recently, and that one was actually worth reading, so maybe you have another good article to recommend…hope springs eternal!
https://www.jci.org/articles/view/169314
Combo is King!
iclight, Explore Professor Keyoumars Ashkan's passion for neurosurgery and his love for @KingsCollegeNHS below as part of their #BrilliantPeople series🧠👇@KingsNeuro @KingsIoPPN https://t.co/yGKt2681Ie
Thanks for the reply and for the compliments, but I believe that you are misinformed.
The P3 data were peer reviewed by independent physicians and qualified statisticians—please refer to JAMA Oncology. You might consider researching credible full-context sources to gather reliable information.
The DCVax-L cell-based technology has been under clinical investigation for a significant period of time, and the overall clinical data in total include three trials spanning many years. Safety and efficacy data have been gathered from trials with external controls and trials with placebo controls. The data include DCVax-L as a monotherapy and in combination with other agents.
The interim PD1 combo data are brilliant, and the trial is significant for a number of reasons relating to FDA guidelines and NIH peer-reviewed grant funding.
https://clinicaltrials.gov/ct2/show/NCT04201873
https://www.fda.gov/media/120721/download
In the combo trial, patients who receive DCVax-L + placebo are being compared to patients who receive DCVax-L + pembrolizumab.
The control arm is receiving DCVax-L. While DCVax-L is not the current SOC, it is highly significant and notable that DCVax-L is being permitted to fill the role of SOC as the best available therapy within this combo study for rGBM. The combo trial also follows the P3 in sequence which in itself validates the findings of the P3 study—the placebo group in the PD1 study would not be receiving DCVax-L today if the preceding P3 trial had not proven its efficacy.
The NIH is the most significant player in this game—If they had any doubt about the P3, the NIH would not continue their support and the FDA would not have permitted the combo trial to commence or continue.
https://clinicaltrials.gov/ct2/show/NCT04201873
The U.S. NIH has supported the DCVax-L platform for years, and the NIH renewed its support in 2022 to continue to fund the development of this technology and to fund research into combination therapies.
NIH-funded DCVax-L research is ongoing at UCLA today.
NIH grants are peer-reviewed and the research that NIH funds is highly scrutinized in advance of the award and also intermittently for the term of the various research projects.
Mr. Newirth is another DCVax-L survivor well surpassing 10 years following a 2012 diagnosis! Congratulations!
https://www.hawaii.edu/news/2017/03/30/newirth-laker-for-a-day/
June 13, 2023 Interview:
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
Grip,
It sounds like you’re suggesting that there have not been any regulatory developments which is extremely misleading…
There has been a vast amount of work being done to ensure compliance with regulatory guidelines globally, and regulators have already weighed in meaningfully in advance of the commercial marketing application(s)…
The MIA was approved recently and is evidence of a regulatory filing plan that has begun to unfold. Further RA applications have been under construction for a significant period of time and include a voluminous catalog of clinical data and analyses. The announcements of regulatory filings are forthcoming.
The recent MIA approval is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.
“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences
https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html
https://www.nice.org.uk/guidance/indevelopment/gid-ta10143
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
Furthermore, there are brilliant compassionate use results. The compassionate use cases generated some astonishing data, and those data could be included in the regulatory filings!
https://t.co/082urSTQ0s
https://www.braintumourresearch.org/media/news/news-item/2022/11/18/astonishing-results-for-brain-tumour-vaccine-trial
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173286107
learningcurve2020, This study found that autologous tumor lystate-loaded dendritic cell vaccination plus standard of care (SOC) was associated with improved survival in both newly diagnosed & recurrent glioblastoma compared with matched controls who received SOC treatment. https://t.co/Uso7Pkh1Kt
And what maneuver are you performing exactly? Pray tell …
On this Thanksgiving Day, we are grateful for another series of insightful and substantive posts from LC…
Perhaps consider looking beyond social media to seek trustworthy full-context sources…
For a reliable appraisal of the trial, its design, and the significance of the resulting survival data, it is advisable to refer to the analyses of qualified physicians. One such analysis can be found on the JAMA Oncology website where the link to the independent peer review and supplementary materials are published.
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html
https://www.jci.org/articles/view/169314
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://hotb.org/wp-content/uploads/2022/05/spore-article-for-donors-4.18.22.pdf
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
learningcurve2020, This study found that autologous tumor lystate-loaded dendritic cell vaccination plus standard of care (SOC) was associated with improved survival in both newly diagnosed & recurrent glioblastoma compared with matched controls who received SOC treatment. https://t.co/Uso7Pkh1Kt
Thanks for posting your prediction, but I think that you’re misinformed and misguided by baseless innuendo posted on social media.
Consider following the regulatory developments and the evolving regulatory environment globally. aesop1 needs better sources too, but he did post an interesting article from Imperial College London News…great excerpt:
https://www.gov.uk/guidance/guidance-on-project-orbis
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://www.jci.org/articles/view/169314
learningcurve2020,
Thanks for asking. Yes, a peer-reviewed report is available:
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
aesop1, Britain's Medicines and Healthcare products Regulatory Agency (MHRA) will officially join #ProjectOrbis on January 1 and work with regulators in the US, Canada, Australia, Singapore and Switzerland on assessing new treatments. https://t.co/JjaXoq6yfh #CancerResearch #Cancers #cancermoonshot #GBM #Immunotherapy #oncology $nwbo #murcidencel #DCVax #CellTherapy https://t.co/BnJHM3myP9
Thank you for highlighting the MHRA!
The forthcoming NICE appraisal of the DCVax-L cell-based technology will be significant as well. Stay tuned!
https://www.nice.org.uk/guidance/indevelopment/gid-ta10143
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
https://www.kcl.ac.uk/people/keyoumars-ashkan
The MIA was approved recently and is evidence of a regulatory filing plan that has begun to unfold. Further RA applications have been under construction for a significant period of time and include a voluminous catalog of clinical data and analyses. The announcements of regulatory filings are forthcoming.
The recent MIA approval is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.
“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences
https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-approval-pediatric-133900403.html
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172639755%5B/color%5D
leaningcurve2020, This study found that autologous tumor lystate-loaded dendritic cell vaccination plus standard of care (SOC) was associated with improved survival in both newly diagnosed & recurrent glioblastoma compared with matched controls who received SOC treatment. https://t.co/Uso7Pkh1Kt
Yes, the Nobel Prize-winning science is there.
https://www.livescience.com/16354-nobel-prize-medicine-2011-immune-research.html
Dr. Steinman’s work lives on at UCLA!
https://clinicaltrials.gov/ct2/show/NCT04201873
https://pubmed.ncbi.nlm.nih.gov/33789235/
https://www.kch.nhs.uk/news/kings-team-wins-professional-excellence-award/
https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/
Thank you for the recognition, but you are mixed up. Try to look beyond social media and baseless innuendo—seek full-context credible sources.
https://www.jci.org/articles/view/169314
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
Here is the NCI link from the previous post. It might not work on this platform.
<iframe src='https://players.brightcove.net/2579504123001/7f409341-f682-4da4-ae97-60b68963646e_default/index.html?videoId=6321979016112'; allowfullscreen frameborder=0></iframe>
https://www.jci.org/articles/view/169314
learningcurve2020,
Most of your posts reflect extraneous distractions. Your comments are shortsighted and misguided in reference to the company, or you veer off track completely. Let us stay focused…
https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html
It is worthwhile to discuss the published developments offered by the independent peer reviewers selected by the medical journal and the developments unfolding from regulators. For a small pre-commercial biotech such as NWBO, regulatory developments will be the most determinative factor of prospective value for their novel cell-based platform technology.
Seek trustworthy full-context sources and independently verify facts. Consider statements published online from those who disclose their conflicts, and weigh opinions critically.
I cannot discern any meaning from your contributions to this message board today, but you did link us to JCI recently and we all appreciated the article immensely—the JCI publication was substantive and insightful!
https://www.jci.org/articles/view/169314
<iframe src='https://players.brightcove.net/2579504123001/7f409341-f682-4da4-ae97-60b68963646e_default/index.html?videoId=6321979016112'; allowfullscreen frameborder=0></iframe>
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html
HyGro, Explore Professor Keyoumars Ashkan's passion for neurosurgery and his love for @KingsCollegeNHS below as part of their #BrilliantPeople series🧠👇@KingsNeuro @KingsIoPPN https://t.co/yGKt2681Ie
Thanks for reposting your views about the ECA again, but you are mixed up and need better sources of credible information.
You are never going to see the FDA or MHRA allow trial participants to be used as lab rats.
The crossover design was required to recruit and retain participants. Who would want to join a GBM study without crossover or remain in a placebo group after developing progressive disease without having the option of receiving an efficacious treatment?
Conclusion: The P3 was exemplary—clinically appropriate and compassionate.
Skip to timestamp 8:01. Dr. Liau again confirms that the crossover was mandated by the FDA.
https://edhub.ama-assn.org/jn-learning/audio-player/18738384
https://www.raps.org/news-and-articles/news-articles/2023/8/fda-finalizes-guidance-on-real-world-evidence-in-d
https://www.raps.org/News-and-Articles/News-Articles/2023/9/FDA%E2%80%99s-Califf-Expect-to-see-more-RWE-based-regulato
https://www.fda.gov/media/171667/download
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
Professor Ashkan is a careful and precise brain surgeon—listen to his words.
Skip to timestamp 13:00 of the ASCO video to hear about the ECA and the SAP.
https://www.kch.nhs.uk/news/kings-team-wins-professional-excellence-award/
The clinical data in total supporting the DCVax-L platform technology include data beyond the trial with the ECA, and the ECA included over a thousand well-matched contemporaneous patients.
The P3 data were peer reviewed by independent physicians and qualified statisticians—refer to JAMA Oncology.
Safety and efficacy data have been gathered from various clinical settings that include both external controls and placebo controls. DCVax-L has been studied as a monotherapy and in combination with other agents.
If you prefer a randomized placebo design, then you’ll love the pembrolizumab PD1 blockade combo study that is ongoing at UCLA today. The study has a placebo design and the placebo participants are receiving DCVax-L as the best available therapy for rGBM.
The interim PD1 combo data are brilliant, and the trial is significant for a number of reasons relating to FDA guidelines and NIH peer-reviewed grant funding.
https://clinicaltrials.gov/ct2/show/NCT04201873
In the combo trial, patients who receive DCVax-L + placebo are being compared to patients who receive DCVax-L + pembrolizumab.
The control arm is receiving DCVax-L. While DCVax-L is not the current SOC, it is highly significant and notable that DCVax-L is being permitted to fill the role of SOC as the best available therapy within this combo study for rGBM. The combo trial also follows the P3 in sequence which in itself validates the findings of the P3 study—the placebo group in the PD1 study would not be receiving DCVax-L today if the preceding P3 trial had not produced reliable evidence of efficacy.
The U.S. NIH has supported the DCVax-L platform for years, and the NIH renewed its support in 2022 to continue to fund the development of this technology and to fund research into combination therapies.
NIH-funded DCVax-L research is ongoing at UCLA today.
NIH grants are peer-reviewed and the research that NIH funds is highly scrutinized in advance of the award and also intermittently for the term of the various research projects.
https://www.bentley.edu/news/new-study-shows-nih-investment-new-drug-approvals-comparable-investment-pharmaceutical
https://www.bentley.edu/news/nih-funded-research-related-every-new-cancer-drug-approved-2010-2016
https://ashpublications.org/ashclinicalnews/news/3819/NIH-Funding-Tied-to-FDA-Approval-of-210-Drugs
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
https://www.uclahealth.org/news/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
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html
ex, Britain's Medicines and Healthcare products Regulatory Agency (MHRA) will officially join #ProjectOrbis on January 1 and work with regulators in the US, Canada, Australia, Singapore and Switzerland on assessing new treatments. https://t.co/JjaXoq6yfh This study found that autologous tumor lystate-loaded dendritic cell vaccination plus standard of care (SOC) was associated with improved survival in both newly diagnosed & recurrent glioblastoma compared with matched controls who received SOC treatment. https://t.co/Uso7Pkh1Kt
I hear you. I have read all of your posts today and I think that you’re misinformed and need more reliable information. Look beyond social media and seek trustworthy full-context sources …
For a reliable appraisal of the trial, its design, and the significance of the resulting survival data, it is advisable to refer to the analyses of qualified physicians. One such analysis can be found on the JAMA Oncology website where the independent peer review was published.
The forthcoming regulatory advisory from MHRA will further enlighten the significance the clinical data, and an assessment from MHRA may be available in advance of advisory decisions from FDA and regulators in other nations.
Additionally, I recommend that you review the forthcoming NICE appraisal of the DCVax-L cell-based technology when it is published.
https://www.nice.org.uk/guidance/indevelopment/gid-ta10143
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
https://www.kcl.ac.uk/people/keyoumars-ashkan
The MIA was approved recently and is evidence of a regulatory filing plan that has begun to unfold. Further RA applications have been under construction for a significant period of time and include a voluminous catalog of clinical data and analyses. The announcements of regulatory filings are forthcoming.
The recent MIA approval is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.
“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences
https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-approval-pediatric-133900403.html
HyGro, Explore Professor Keyoumars Ashkan's passion for neurosurgery and his love for @KingsCollegeNHS below as part of their #BrilliantPeople series🧠👇@KingsNeuro @KingsIoPPN https://t.co/yGKt2681Ie
Thanks for reposting your views about the ECA again, but you are mixed up and need better sources of credible information.
You are never going to see the FDA or MHRA allow trial participants to be used as lab rats.
The crossover design was required to recruit and retain participants. Who would want to join a GBM study without crossover or remain in a placebo group after developing progressive disease without having the option of receiving an efficacious treatment?
Conclusion: The P3 was exemplary—clinically appropriate and compassionate.
Skip to timestamp 8:01. Dr. Liau again confirms that the crossover was mandated by the FDA.
https://edhub.ama-assn.org/jn-learning/audio-player/18738384
https://www.raps.org/news-and-articles/news-articles/2023/8/fda-finalizes-guidance-on-real-world-evidence-in-d
https://www.raps.org/News-and-Articles/News-Articles/2023/9/FDA%E2%80%99s-Califf-Expect-to-see-more-RWE-based-regulato
https://www.fda.gov/media/171667/download
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
Professor Ashkan is a careful and precise brain surgeon—listen to his words.
Skip to timestamp 13:00 of the ASCO video to hear about the ECA and the SAP.
https://www.kch.nhs.uk/news/kings-team-wins-professional-excellence-award/
The clinical data in total supporting the DCVax-L platform technology include data beyond the trial with the ECA, and the ECA included over a thousand well-matched contemporaneous patients.
The P3 data were peer reviewed by independent physicians and qualified statisticians—refer to JAMA Oncology.
Safety and efficacy data have been gathered from various clinical settings that include both external controls and placebo controls. DCVax-L has been studied as a monotherapy and in combination with other agents.
If you prefer a randomized placebo design, then you’ll love the pembrolizumab PD1 blockade combo study that is ongoing at UCLA today. The study has a placebo design and the placebo participants are receiving DCVax-L as the best available therapy for rGBM.
The interim PD1 combo data are brilliant, and the trial is significant for a number of reasons relating to FDA guidelines and NIH peer-reviewed grant funding.
https://clinicaltrials.gov/ct2/show/NCT04201873
In the combo trial, patients who receive DCVax-L + placebo are being compared to patients who receive DCVax-L + pembrolizumab.
The control arm is receiving DCVax-L. While DCVax-L is not the current SOC, it is highly significant and notable that DCVax-L is being permitted to fill the role of SOC as the best available therapy within this combo study for rGBM. The combo trial also follows the P3 in sequence which in itself validates the findings of the P3 study—the placebo group in the PD1 study would not be receiving DCVax-L today if the preceding P3 trial had not produced reliable evidence of efficacy.
The U.S. NIH has supported the DCVax-L platform for years, and the NIH renewed its support in 2022 to continue to fund the development of this technology and to fund research into combination therapies.
NIH-funded DCVax-L research is ongoing at UCLA today.
NIH grants are peer-reviewed and the research that NIH funds is highly scrutinized in advance of the award and also intermittently for the term of the various research projects.
https://www.bentley.edu/news/new-study-shows-nih-investment-new-drug-approvals-comparable-investment-pharmaceutical
https://www.bentley.edu/news/nih-funded-research-related-every-new-cancer-drug-approved-2010-2016
https://ashpublications.org/ashclinicalnews/news/3819/NIH-Funding-Tied-to-FDA-Approval-of-210-Drugs
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
https://www.uclahealth.org/news/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
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html
HyGro, Explore Professor Keyoumars Ashkan's passion for neurosurgery and his love for @KingsCollegeNHS below as part of their #BrilliantPeople series🧠👇@KingsNeuro @KingsIoPPN https://t.co/yGKt2681Ie
Thanks for reposting your views about the ECA again, but you are mixed up and need better sources of credible information.
You are never going to see the FDA or MHRA allow trial participants to be used as lab rats.
The crossover design was required to recruit and retain participants. Who would want to join a GBM study without crossover or remain in a placebo group after developing progressive disease without having the option of receiving an efficacious treatment?
Conclusion: The P3 was exemplary—clinically appropriate and compassionate.
Skip to timestamp 8:01. Dr. Liau again confirms that the crossover was mandated by the FDA.
https://edhub.ama-assn.org/jn-learning/audio-player/18738384
https://www.raps.org/news-and-articles/news-articles/2023/8/fda-finalizes-guidance-on-real-world-evidence-in-d
https://www.raps.org/News-and-Articles/News-Articles/2023/9/FDA%E2%80%99s-Califf-Expect-to-see-more-RWE-based-regulato
https://www.fda.gov/media/171667/download
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
Professor Ashkan is a careful and precise brain surgeon—listen to his words.
Skip to timestamp 13:00 of the ASCO video to hear about the ECA and the SAP.
https://www.kch.nhs.uk/news/kings-team-wins-professional-excellence-award/
The clinical data in total supporting the DCVax-L platform technology include data beyond the trial with the ECA, and the ECA included over a thousand well-matched contemporaneous patients.
The P3 data were peer reviewed by independent physicians and qualified statisticians—refer to JAMA Oncology.
Safety and efficacy data have been gathered from various clinical settings that include both external controls and placebo controls. DCVax-L has been studied as a monotherapy and in combination with other agents.
If you prefer a randomized placebo design, then you’ll love the pembrolizumab PD1 blockade combo study that is ongoing at UCLA today. The study has a placebo design and the placebo participants are receiving DCVax-L as the best available therapy for rGBM.
The interim PD1 combo data are brilliant, and the trial is significant for a number of reasons relating to FDA guidelines and NIH peer-reviewed grant funding.
https://clinicaltrials.gov/ct2/show/NCT04201873
In the combo trial, patients who receive DCVax-L + placebo are being compared to patients who receive DCVax-L + pembrolizumab.
The control arm is receiving DCVax-L. While DCVax-L is not the current SOC, it is highly significant and notable that DCVax-L is being permitted to fill the role of SOC as the best available therapy within this combo study for rGBM. The combo trial also follows the P3 in sequence which in itself validates the findings of the P3 study—the placebo group in the PD1 study would not be receiving DCVax-L today if the preceding P3 trial had not produced reliable evidence of efficacy.
The U.S. NIH has supported the DCVax-L platform for years, and the NIH renewed its support in 2022 to continue to fund the development of this technology and to fund research into combination therapies.
NIH-funded DCVax-L research is ongoing at UCLA today.
NIH grants are peer-reviewed and the research that NIH funds is highly scrutinized in advance of the award and also intermittently for the term of the various research projects.
https://www.bentley.edu/news/new-study-shows-nih-investment-new-drug-approvals-comparable-investment-pharmaceutical
https://www.bentley.edu/news/nih-funded-research-related-every-new-cancer-drug-approved-2010-2016
https://ashpublications.org/ashclinicalnews/news/3819/NIH-Funding-Tied-to-FDA-Approval-of-210-Drugs
https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers
https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials
https://www.uclahealth.org/news/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
https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html
That’s awesome! I lived in Buffalo—I actually grew up there—there is some beautiful research going on in New York! I’ve been to the Roswell Park hospital and they provided invaluable medical care to my family!
Thank you for posting!
The DCVax-L cell-based platform technology is awesome too!
https://www.theguardian.com/science/2022/nov/17/im-just-carrying-on-vaccine-gives-brain-cancer-patient-years-of-extra-life
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847