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flipper44,
I have messaged Richard Parker, Senior GMDP Inspector - MHRA London, asking him to further define, via a response, what they (MHRA) mean when they state " the product is in the process" of being approved. (actually your question.)
My email (Feb. 22, 2023)
Thanks Bright Boy.
flipper44,
Reply from MHRA (NOV.2021)
Prof. Keyoumars Ashkan discussing the DCVax-L trial today.
We're grateful to Prof. Keyoumars Ashkan for discussing the DCVax-L trial and future opportunities for this exciting new treatment in patients with #GBM
— NANSIG (Neurology and Neurosurgery Interest Group) (@NANSIG1) February 18, 2023
We're really excited to see future applications of this research and the avenues it opens up‼️#NANSIG2023 pic.twitter.com/IrdDtZXCHs
https://twitter.com/BIO99_BIO99/status/1619480982922612736?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1619480982922612736%7Ctwgr%5E0e35ec7f5c5275617c7e642f0e31587024a0927d%7Ctwcon%5Es1_&ref_url=https%3A%2F%2Finvestorshub.advfn.com%2Fboards%2Fread_msg.aspx%3Fmessage_id%3D171063195
Philadelphia’s Cellicon Valley????
Center for Breakthrough Medicines (CBM) and Advent Bioservices (Sawston UK) will implement Autolomous Digital Platform that will support end-to-end cell and gene therapy manufacturing processes. (CBM - in full use in April. Sawston- already finalized???)
Kwok Pang
Chief Operating Officer at Autolomous
3 days ago
Great job! Thanks froggmister!
Story of breakthrough in brain cancer DCVax-L vaccine trial also on TikTok.https://www.tiktok.com/@danacasullo1/video/7185912147489066283?_r=1&_t=8YpYUhulXMg&is_from_webapp=v1&item_id=7185912147489066283
Dana Casullo updated last paragraph!
Respectfully, the story is incomplete if there is no mention of Dr. Linda Liau and Northwest Biotherapeutics (NWBO). Without them, Lifespan would not have been one of 94 sites worldwide to be a part of this study. Thank you.
— Peter Kostis (@peterjkostis) January 7, 2023
@peterjkostis updated last paragraph!
— Dana Casullo (@DanaCasullo) January 7, 2023
Awesome!
— Peter Kostis (@peterjkostis) January 7, 2023
Thanks @DanaCasullo for covering this story. Truly is a major achievement in cancer therapy.
— Justin Keister MS DABR (@justinkeister5) January 7, 2023
The #glioblastoma #cancer vaccine extended his husband's life by more than 5 years. “…during this time he was able to complete his goal of going to all 50 states… He really had a good quality of life until even a month before he died." Via @NBC10 https://t.co/UPRtwDp57L
— Kathleen Hart (@kathchats) January 6, 2023
Thanks StonkMaster.
Researchers announce breakthrough in brain cancer vaccine trial
Thanks miltong!
They have reached the €40K mark.
Tracy's husband today:
Thanks for the update hope4patients.
At 22.4 months from surgery:
5 patients are lost to follow up between 0 and 22.4 months.
159/160 patients are dead (n=331)
166/167 patients are at risk (n=331)
IMO.
23rd event on Sentiment’s chart = about 9.3 months/ 40.7 weeks.
Northwest Biotherapeutics (NWBO) - 2022 Annual Shareholders Meeting
Thanks flipper44! Merry Christmas!
Thanks evanstony!
Dec.15, 2022
Husband Tracy:
Thanks hope4patients! Merry Christmas.
Fundraiser launched to help Louth mum beat the odds to survive deadliest form of cancer.
https://www.independent.ie/regionals/louth/news/fundraiser-launched-to-help-louth-mum-beat-the-odds-to-survive-deadliest-form-of-cancer-42233294.html
Happy Birthday NOTBOB17!
Happy Birthday CaptainObvious!
Happy birthday Laura!
Laura's mum:
Critical review of the report on the DCvax-L trial: the trial did not meet its prospectively defined endpoint and post-hoc analyses with poorly selected external controls do not replace a proper prospective trial https://t.co/3kJnHYW4P6
— Martin van den Bent (@MartinvdenBent) December 23, 2022
Flipper44,
Interesting study published Dec.20, 2022 in Nature Cancer.
A single-cell atlas of glioblastoma evolution under therapy reveals cell-intrinsic and cell-extrinsic therapeutic targets.
https://www.nature.com/articles/s43018-022-00475-x
Article:
UCSF Researchers Identify the Cellular Source of Recurrent Glioblastoma.
https://www.insideprecisionmedicine.com/topics/oncology/oncologics/ucsf-researchers-identify-the-cellular-source-of-recurrent-glioblastoma/
http://web.archive.org/web/20211220205123/https://cms.mhra.gov.uk/mhra/mia/uk-miaimp-54923
Flipper is right IMO.
This is usually because there has been a variation to the manufacturing authorisation submitted and subsequently approved. The authorisation date will therefore have changed.
Thank you Survivor2012! I'm beyond grateful.
Thank you Arby2000! Your act of kindness means the world to Tracy and her family!
Thank you Berry501! Much appreciated!
Thank you CherryTree1! Your support means the world.
hyperopia,
Thanks for the additional information.
First time i read CEO Hans Keirstead's Twitter comments. Hmm....
Phase 2A Study of #SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed #Glioblastoma published today in Journal of Clinical Oncology
Phase IIa Study of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma
https://ascopubs.org/doi/full/10.1200/JCO.22.00996
ABSTRACT
PURPOSE
Despite intensive treatment with surgery, radiation therapy, temozolomide (TMZ) chemotherapy, and tumor-treating fields, mortality of newly diagnosed glioblastoma (nGBM) remains very high. SurVaxM is a peptide vaccine conjugate that has been shown to activate the immune system against its target molecule survivin, which is highly expressed by glioblastoma cells. We conducted a phase IIa, open-label, multicenter trial evaluating the safety, immunologic effects, and survival of patients with nGBM receiving SurVaxM plus adjuvant TMZ following surgery and chemoradiation (ClinicalTrials.gov identifier: NCT02455557).
METHODS
Sixty-four patients with resected nGBM were enrolled including 38 men and 26 women, in the age range of 20-82 years. Following craniotomy and fractionated radiation therapy with concurrent TMZ, patients received four doses of SurVaxM (500 µg once every 2 weeks) in Montanide ISA-51 plus sargramostim (granulocyte macrophage colony-stimulating factor) subcutaneously. Patients subsequently received adjuvant TMZ and maintenance SurVaxM concurrently until progression. Progression-free survival (PFS) and overall survival (OS) were reported. Immunologic responses to SurVaxM were assessed.
RESULTS
SurVaxM plus TMZ was well tolerated with no serious adverse events attributable to SurVaxM. Of the 63 patients who were evaluable for outcome, 60 (95.2%) remained progression-free 6 months after diagnosis (prespecified primary end point). Median PFS was 11.4 months and median OS was 25.9 months measured from first dose of SurVaxM. SurVaxM produced survivin-specific CD8+ T cells and antibody/immunoglobulin G titers. Apparent clinical benefit of SurVaxM was observed in both methylated and unmethylated patients.
CONCLUSION
SurVaxM appeared to be safe and well tolerated. The combination represents a promising therapy for nGBM. For patients with nGBM treated in this manner, PFS may be an acceptable surrogate for OS. A large randomized clinical trial of SurVaxM for nGBM is in progress.
Thank you for your donation CaptainObvious!
From Daniel Verblis (Organisator) :
today
OncoJock,
Watch this Brain Tumor Webinar:
May 31, 2020
Daniela A. Bota, M.D., Ph.D
The Promise of Immunotherapy For Glioblastomas!
DCVax-L Question: Min. 47:50
DC-ATA Preliminary Results (March 2020, 60 patients) Min 22:32
hoffmann,
see post 446214.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167982336
Reply from MHRA:
Phase 2 study of AV-GBM-1 (a tumor-initiating cell targeted dendritic cell vaccine) in newly diagnosed Glioblastoma patients: safety and efficacy assessment.
Daniela A. Bota, Thomas H. Taylor, David E. Piccioni, Christopher M. Duma, Renato V. LaRocca, Santosh Kesari, Jose A. Carrillo, Mehrdad Abedi, Robert D. Aiken, Frank P. K. Hsu, Xiao-Tang Kong, Candace Hsieh, Peter G. Bota, Gabriel I. Nistor, Hans S. Keirstead & Robert O. Dillman
Published: 14 December 2022
New!📍
— Journal of Experimental & Clinical Cancer Research (@JournalofExper1) December 15, 2022
Phase 2 study of AV-GBM-1 (a tumor-initiating cell targeted #dendriticcellvaccine) in newly diagnosed #Glioblastoma patients: safety and efficacy assessment
Full text👇https://t.co/sHwUEV9l3V#Survival@IREISGufficiale pic.twitter.com/8LlP1cKLO4
Thanks for clarifying Thermo. Much appreciated!
Ex,
You said:
dr lowenstein,
I was one of the 500 attendees. It"s an accurate summary of LL's presentation.Thank you hoffmann!
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170628836
Thank you hoffmann!
12-5-2022 Webinar: Dr. Linda Liau on DcVax for Glioblastoma