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Sander,
Friday, 01/04/19 05:30:25 PM
You wrote:
I do not have any position in NWBO long or short.
Isnt the rule in biotech to get the hell out the moment a biotech company starts PRing its second drug in their pipeline. Isnt that what $NWBO is doing now? Im long in $NWBO but $NBWO first things first!!!
Has anybody thought hard about the fact that MGMT methylated patients live longer even without DCVax-L, and what that implies? Ex
Wow, check this out. Still preliminary, but the durations of survival are pretty doggone impressive! #glioma #BrainTumour #Glioblastoma #vaccine
especially for those patients whose tumors had MGMT promoter methylation, the addition of the vaccine seems to have extended their median survival to nearly three full years
Wow, check this out. Still preliminary, but the durations of survival are pretty doggone impressive! #glioma #BrainTumour #Glioblastoma #vaccine https://t.co/NCDHRYypOb
— Craig Horbinski (@CraigHorbinski) May 30, 2018
Abeta,
In 2012 the trial size had been increased up to 312 patients from previous 240 patients.
IMO the 24 UK patients are included in the 240 early patients.(see date Ethics Committee Opinion 2011-10-5 = Oct 5, 2011)
At that moment: E.8.6.3 specify the regions in which trial sites are planned: Germany, United Kingdom and United States.
So: 240-24= 216 planned to be included in United States.
24 in the UK.
87 in Germany.
remaining 21 of 348 patients planned ( IMO decision made between second half of 2012 and beginning of 2013???) to be included in Canada IMO.
The planned number of subjects to be included in EEA = 132.
abeta,
Thank you!
The planned number of subjects to be included in te member state Germany is 87.
This quote is for Longfellow95:
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition): Patients will be treated by their physicians according to the current standard of care.
What is your point?
She once had something like 70% after the bailout. She sold enough of NWBO off to the market that she was down under 5% before reloading to about her current 15% (many ways to measure this).
Options and warrants that can be converted into common shares within the next 60 days should be included in the shareholdings listed below.
We know that because of the cross-over trial design, nearly 90% of the ITT population received DCVax-L.
232 patients of the treatment group and 66 patients of the placebo group = 298 patients who received DCVax-L (90% of 331 ITT population)
I don't believe that a majority of the 66 are pseudo PFS placebo cross-over patients, maybe a few.
Te authors of this scientific article, published online February 21 2019, seem to think otherwise.
Current State of Immunotherapy for Treatment of Glioblastoma.
Tresa McGranahan, MD PhD, 1 Kate Elizabeth Therkelsen, MD,2 Sarah Ahmad, MD,2 and Seema Nagpal, MD2
DC-Vax-L uses whole tumor lysate to pulse patient-derived DCs. Currently over 10 years from diagnosis, some of the patients enrolled in the original phase 1 study of this vaccine are still alive [43]. The phase 3 of DC-Vax-L in newly diagnosed GBM results is still blinded; however, recent reports described a mOS of 23.1 months for all participants (90% of whom received the DC-Vax-L treatment due to crossover design).
While the data remains blinded, there are concerns that this may only be interpreted as a single-arm study of 331 patients due to cross over as a result of pseudo-progression and not true progression [44•].
Again promising are reports of durable responders in the phase 3 with survival exceeding 7 years. This vaccine is also being studied in a phase 2 clinical trial in combination with the PD-1 inhibitor, nivo (NCT03014804).
Graham Introduces Glioblastoma Awareness Day Resolution
May 16 2019
https://www.lgraham.senate.gov/public/index.cfm/press-releases?ContentRecord_id=8C6D7E9F-6591-40F7-8B8C-83D9327702D2
WASHINGTON – U.S. Senator Lindsey Graham (R-South Carolina) today introduced a Senate Resolution designating July 17, 2019 as Glioblastoma Awareness Day.
“Glioblastoma is a devastating brain disease that has taken the lives of two of my very close friends and colleagues, Ted Kennedy and my dearest friend John McCain,” said Graham. “This Senate resolution shines a light on this terrible disease.”
The resolution:
• Designates July 17, 2019 as Glioblastoma Awareness Day.
• Increases public awareness of glioblastoma and honors those individuals who have lost their lives to that devastating disease or are currently living with it.
• Supports efforts to develop better treatments for glioblastoma that will improve the long-term prognosis of individuals diagnosed with glioblastoma and expresses its support for those individuals who are battling brain tumors, as well as the families, friends, and caregivers of those individuals.
• Urges a collaborative approach to brain tumor research, which is a promising means of advancing understanding of, and treatment for, glioblastoma.
“I want to thank my cosponsors, Senate Majority Leader Mitch McConnell, Senator Martha McSally, Senator Kyrsten Sinema, and Senator Elizabeth Warren,” concluded Graham. “We are committed to combating and defeating this terrible disease.”
It's about time they got Sawston licensed and up and running.
It is locations such as the UK that will help ensure these new therapies become more affordable, stable and accessible in the future.
Looking ahead this year, there are already plans secured for significant facilities expansion throughout the UK (primarily from companies such as Advent BioServices, Cell and Gene Therapy Catapult and Cobra Biologics), with an additional 1500m2 of clean room space (representing an approximate 20% overall increase) scheduled to become active before the end 2019.
Since 2017, there has been a 60% increase in the UK’s GMP licensing facilities. This all demonstrates the UK is well positioned to continue strengthening its global position in this complex market.
I found this job offer from 9 days ago. Could it be for Advent Bioservices???
GMP Production Scientist – Cell Therapy- London / Cambridge
An excellent opportunity has arisen for a GMP Production Scientist to join an emerging contract bioservices company. As an organisation they provide innovative GMP manufacturing services and process development for novel cell and gene therapy products.
The role will initially be based at their site in London and will move to South Cambridge in the latter part of the year, as they are opening a brand new state of the art manufacturing facility there.
Reporting into the GMP Production Manager the GMP Production Scientist will be responsible for performing batch manufacturing of the company’s contract manufacturing products to support the delivery of Advanced Therapeutic Medicinal Products (ATMPs) as both Specials and as Investigational Medicinal Products.
Responsibilities:
*GMP production within sterile environments, formulation and banking of cellular therapy products. This will include cell culture and raw material support in compliance with validated standard operating procedures (SOPs) and regulatory requirements
*Perform and assist in the development of QC assays as part of product release, including use of flow cytometry, ELISA and ELISPOT assays, microscopy techniques, cell culture, SDS electrophoresis
*Preparing technical reports and other clinical and GMP required documentation.
*Support in process engineering and validation of cellular therapy products for successful technology transfer into the facilities with full GMP compliance
*Plan and undertake validation of new production equipment.
*Undertake daily GMP production housekeeping activities and administration.
*Assist in the labelling, packaging, storage and shipping of cellular therapy products.
Key requirements:
-BSc or MSc in a relevant scientific subject
-A minimum of 2 years’ experience in the aseptic manufacture of cellular therapies in a clean room environment
-Working knowledge of GMP for the manufacture of ATMPS
-Experience of cell culture techniques
-Additional experience of viral vector production, purification and gene therapy manufacture would be regarded but is not essential
https://www.pararecruit.com/jobs/gmp-production-scientist-cell-therapy-london-cambridge/
This is from LinkedIn (old news):
Advent Bioservices are a contract bioservices organisation providing GMP manufacturing services for a variety of ATMPs and related products, process development (PD) and ancillary services.
Advent’s head office is in London, we have lab facilities at the Royal Free Hospital Centre for Cell, Gene and Tissue Therapeutics and
a state-of-the-art manufacturing facility in South Cambridgeshire. Phase 1 of the new facility in Cambridgeshire, is due to be licensed and operational from Q1 2018 and includes two completed suites (185m2 i.a. each) comprising B, C and PD/QC labs, offices and storage space. The facility has infrastructure in situ and capacity for 7,566m2 additional development.
https://nl.linkedin.com/company/advent-bioservices
21 July 2015
Case-Based Review: newly diagnosed glioblastoma.
https://academic.oup.com/nop/article/2/3/106/1036699
The utilization of fluorescence guidance has been recently advocated. The use of fluorophores such as 5-aminolevulenic acid (5-ALA) or fluorescein, which accumulate in areas of blood brain disruption, can be a powerful adjunct that allows for the accurate identification of tumor borders and possible residual disease at the time of resection.34–36 In a systematic review of 10 studies, patients who underwent surgery utilizing 5-ALA for maximizing resection had improved 6-month progression-free survival and overall survival.37 A multicenter, randomized, phase III trial of 5-ALA-guided surgery found higher rates of gross total resection and 6-month progression-free survival in the 5-ALA group without any increase in adverse events.38
Thanks Evaluate, and St.Jude Medical Center is one of the Study Locations for DCVAX-L phase III.
http://www.stjudemedicalcenter.org/about-us/newsroom/press-releases/2018/st-jude-offers-game-changing-surgical-technique-/
2019 Seattle Brain Cancer Walk - Live with Dr Charles Cobbs. (May 5, 2019)
we've got clinical trials going on now at the Ivy Center and in other places with immunotherapy, vaccines against cancer all these things are just about to explode and take off.
Sentiment,
you wrote:
As of 3/27/17, we had 108 ALIVE. :)
Exwannabe?
You wrote:
Given the top 100 median, and the enrollment curve, I would guess the number of deaths in that population is more like 25%, which would put the known alive at SNO at 63.
The checkmate 498 (Opdivo unmethylated GBM trial) failure is sad, not unexpected, but it is consistent with LP recently stating the field is moving toward DCVax.
Info on NWBO subsidiary in the Netherlands appears to be:
Northwest Biotherapeutics BV (BV is an abbreviation for Besloten Venootschap, a private company with limited liability. BV has similar features as the German "GmbH", the American "LLC", or the English "Ltd".)
Kingsfordweg 151 1043 GR Amsterdam
https://drimble.nl/bedrijf/amsterdam/42606225/northwest-biotherapeutics-bv.html
Meirluc,
I have compared all curves (2017 and 2018) and this is my final conclusion:
Data 2017
108 patients alive. 68 patients alive between month 18 and month 36 and 40 patients alive beyond month 36.
12 LTFU = 5 methylated LTFU between month 0 and month 18, 5 unmethylated LTFU between month 0 and month 18 and 2 "unknown" LTFU (censor 4 and censor 46 on Sentiment curve: https://investorshub.advfn.com/uimage/uploads/2018/10/22/gddzjCombined_charts_no_notes_revised_-lykiri.jpg ).
207 patients died between month 0 and month 36, 3 patients died between month 36 and month 37 and 1 died probably around month 88.
Total number of patients who died ( March 2017) : 207+3+1= 211.
211 (dead) + 12 LTFU + 108 alive = 331 ITT.
Data 2018.
Of the original 12 LTFU, 5 are still LTFU and censored between month 0 and month 14 .
7 of the original 12 LTFU were found dead. You can find them all(7) when you analyze every step down on the OS curve NOV.2018. (I have to admit that is hard work)
Of the 68 patients still alive in 2017 between month 18 and month 36 , 19 died between month 18 and month 36 and 6 out of the 68 were new LTFU. ( 1 is censored around month 23, 1 is censored around month 24 , 1 is censored around month 30 an 3 are censored between month 35 and month 36).
I strongly believe that 4 of the hashmarks just prior to the 3 year line will be found alive at month 36 when they do the final data lock.
That will bring the total of patients at risk at month 36 = 91 (87 + 4).
Between month 36 and month 37 you can see 5 or 6 steps down on the OS curve Nov. 2018.
On the OS curve 2017 there are 3 steps down between month 36 and month 37. That means that 2 or 3 patients of that last group of 43 patients (87-44) died between month 36 and month 37.
So, we are sure that 19 patients died between month 18 and month 36, 2 or 3 died between month 36 and month 37 an probably the 2 new censored patients around month 23 and month 24 will be found dead when they do the final analyses.
19 + 2 (or 3) + 2 LTFU= 23 or 24 patients out of 108 alive March 2017 died between month 18 and month 37.(these patients died between March 2017 and Oct.2018)
We don't know how the patients are doing who lived beyond month 37.
I believe that the majority of these patients are still alive today.
IMO, most of these patients are patients with no tumor reocurrence and i think the other patients are pseudo PFS.
I found evidence for this opinion here:
-Video presentation Linda Liau 2015, 2016 and 2019.
-Comment of Linda Liau after the publication of the 2017 interim data.
-Interview Linda Liau Magazine Spring 2018.
-Interview Linda Liau June 2018.
-Marnix Bosch Asco presentation 2018.
-Presentation Linda Powers Jan.2019.
-OS curves 2017 and 2018 + a lot of data.
-Some PR's from the compagny.
Conclusion: IMO it is possible that around 74 patients are still alive today.
Some additional information about the 19 patients out of 108 who died between month 18 and month 36:
6 patients are methylated. (3 died between month 24 and month 30 and 3 died between month 30 and month 36)
13 patients are unmethylated. (3 died between month 18 and month 24 , 6 died between month 24 and month 30 and 4 died between month 30 and month 36)
I advise every long to analyze all OS curves. IMO you will discover additional interesting information.
Congratulations to Dr. Linda Liau, Chair of Neurosurgery at David Geffen School of Medicine at UCLA on receiving the Bittner Award at #AANS2019!
https://www.facebook.com/NSTumorSection/photos/a.1171193949659353/1940394679405939/?type=3&theater
The tumor sessions at the 2019 AANS Annual Scientific Meeting are only a few weeks away. We are excited that Linda Liau, MD, PhD, MBA, FAANS, has agreed to headline our first scientific session as the 2019 Bittner lecturer. We anticipate her talk will cover her groundbreaking work in bringing advanced brain tumor immunotherapy from bench to bedside. Dr. Liau’s talk is followed by oral presentations from the top-scoring abstracts and award winners.
the Wonder of Women Summit on April 11.
Dr. Linda Liau, a mother of two and renowned neurosurgeon-scientist at the Geffen School, had the final word.
“There is only one thing harder than brain surgery,” said Liau, whose quest to find a cure for glioblastoma stems from her mother’s death from brain cancer. “And that’s motherhood.”
The AANS CNS Joint Section on Tumors
April 15, 2019
Congratulations to Dr. Linda Liau, Chair of Neurosurgery at David Geffen School of Medicine at UCLA on receiving the Bittner Award at #AANS2019!
https://www.facebook.com/NSTumorSection/photos/a.1171193949659353/1940394679405939/?type=3&theater
Abeta,
Linda Liau says the following about treatment patients and pseudo-progression (Dec.20 2018 -Campbell Lecturer Details New Directions in Brain Cancer Treatment):
Liau also described one of the main challenges is measuring whether an immunotherapy drug is working against a glioblastoma tumor. After injections of these drugs, a tumor may enlarge (“pseudoprogression”) for possibly 6 months before it gets smaller. Therefore, standard imaging techniques, such as MRI, to assess whether tumors are growing or shrinking in response to treatment are not as sufficient in brain cancer.
In reviewing the Phase III GBM Trial, Dr. Bosch’s presentation also took note of encouraging projections by independent analysts in regard to the median overall survival (OS) and median progression free survival (PFS) based on the trial metrics reported by the Company during ASCO.
Thank you sharpie510! Great find!
Finally, those last 31 patients would have entered the trial between August 2015 and November 2015. The date that the blended data was determined was in March 2017, 16 to 20 months later. So I think that would mean that all patients alive on the chart at 16 to 18 months in March 2017 would have been from that group of 31. I think that would be at about censored patient 10 on the combined chart to censored patient 30, or about 21 patients (you don't subtract - but start with 10 and count to 30). On the methylated chart, that's patient #4 to patient #15, or 12 patients. On the unmethylated chart, that's patient #6 to patient #14 or 9 patients. We don't know how the remaining 10 patients were broken down as to their methylation status. But still... that's 67% of the 31 still alive between 16 to 20 months - it's really 18 months as there were none alive at 16 months. If those 31 followed the entire trial in terms of how many were methylated and unmethylated (45% and 55%), then there would have been about 14 methylated, and 17 unmethylated.
At least that's how I see it. Maybe I'm missing something.
Novocure did not provide their enrollment curve. They did not provide any further updates. The played games with extrapolation to the point that they claimed 29% survival in a subgroup of 43 where only one out of 43 patients actually lived to five years at data cutoff. They did not update this number even though they could have easily update the number alive forward by one year. Instead they hid the information and advertised in presentations that 29.3% patients that wore the device 22-24 hours a day lived to five years. Not mentioning that was from an actual sample of 1 patient alive at five years. You would probably want to know that if you were deciding which therapy to expend an additional $420,000 dollars on to live a median 4 months longer (50% chance) than you would with SOC. You'd probably want to know this if you are going to decide if it's worth wearing 24/7 and lugging around. If it's worth the side effects. My guess is you'd want to know.
I've fallen at the first hurdle. Where does the 162 come from?
Oh yes. It must be their cited number of confirmed unmeth.
Checked.
So yes, 23 out 162 made 36 months (as of SNO).
If we breakdown on the actual ratio split of 70:30, the estimate for total treatment unmeth would be 113 at outset.
If you assume that all of these were treatment that would be
23/113 or 20.3%. Just over a percent down on your 21.5%.
If DCVax had no effect, then 70% of the 23 would be 16 treatment and 7 control. Clearly, I agree that more than 70% of the 23 will have been treatment. In fact I'd say nearly all.
But, there usually is an outlier or two who bucks the odds. So I'll say just one of the 23 started out as control.
And 22 started out as treatment. And that comes out at 19.5%.
So my best estimate of OS36 for treatment unmeth is 19.5%
And the corresponding figure for control unmeth would be 1 out of 23 or about 4.3%. But it's all guesswork, and there could be 2 or 3 control unmeth making 36 months, or it indeed could be none.
But, he is on the trial steering committee.
I wonder if Dr. Steven Brem of te interview is the same Steven S. Brem M.D of te Clinical Advisory Board?
Northwest Biotherapeutics
Thema: Presse: Experts guide brain cancer vaccine development
Sep 2005
"We are proud to have such a distinguished Clinical Advisory Board with
some of the world's most respected and experienced experts in the fields of brain cancer, neurology, and clinical design, who will work together to advance our personalized vaccines for the benefit of patients with
Glioblastoma multiforme," said Alton Boynton, Ph.D., President and Chief
Operating Officer of Northwest Biotherapeutics.
The Northwest Biotherapeutics Clinical Advisory Board for DCVax(R)-Brain
is comprised of:
........
Steven S. Brem, M.D.
Dr. Brem is Chief of the Neurosurgery Service, Director, Neuro-Oncology
research laboratory, and Division Chief, Neuro-Oncology, for the H. Lee
Moffitt Cancer Center & Research Institute of the University of South Florida.
Dr. Brem also serves as a New Approaches to Brain Tumor Therapy (NABTT)
Investigator. His research interests include frameless image-guided surgery,
surgery of brain metastasis and malignant tumors, experimental therapeutics,
anti-angiogenesis therapies, pituitary surgery and skull base surgery. Dr.
Brem received a B.A. from Rutgers University and an M.D. from Harvard Medical
School.
https://forum.hirntumorhilfe.de/neuroonkologie/presse-experts-guide-brain-cancer-vaccine-development-568.html
Yes and it is exciting to hear that from a doctor who had performed over 4000 brain tumor surgeries.
We’ve also been very active in the DCVax, which was started at UCLA but now extended to Penn and other sites. And the interesting thing of that trial, which we reported some preliminary data, is that a large percentage of the patients are now living beyond 3 years, so that is a unique approach in that the patients own tumor creates their very individual vaccine looking at their own panel of antigens. So we’re excited by that approach and we’ll be hearing more about that in the future.
Dr. Shah: Okay, so my understanding of the DCVax is that you have to take the tissue out and then generate something against the dendritic cells within that admixture.
Dr. Brem: Yes.
Dr. Shah: Could you tell us a little bit more about where that therapy stands as of now and what kind of efficacy we're getting?
Dr. Brem: Well, a very large multi-national study was concluded and so that is going to…as the data matures, that will be going to FDA. We hope that that gets approved. We don’t know, but it’s an exciting study.
https://spectrumnews1.com/ca/la-west/la-stories/2019/04/08/la-stories--renowned-brain-surgeon-dr--linda-liau?cid=share_twitter#
Sharpie510,
Thanks for posting!
I want to add this video:
International Women’s Day: Top wisdom from top UCLA scientists.(March 8, 2019)
Sentiment,
Thank you!
WOODFORD
FEBRUARYROUNDUP
Mike Hogg
08 Mar 2019 at 10:38 am
Hi Mitch, my monthly NWBO question this time is: has Neil spoken with the new IR man David Innes and if so any feedback for your investors on this. Thanks.
Mitchell Fraser-Jones
Author
12 Mar 2019 at 3:41 pm
Hi Mike,
Not as far as I am aware.
Kind regards
Mitch
https://woodfordfunds.com/words/insights/roundup-february-2019/#comment-13041
Thank you Marzan. Good job! Did you saw Sarah's and Brad's story on the construction?
Sarah Rigby and Brad Silver, two of the four patients who gave a testimony at the ASCO presentation 2018.
It is nice to see that both are doing well.
NOTE: I love your sincere comments.
Consistency and reliability is what NWBO stated they needed to accomplish to meet the fourth criteria of the second stage in the EAMS process.
The second step under the EAMS is MHRA’s determination of a Scientific Opinion about the product candidate’s benefits and risks, based on available clinical data. A positive or negative Scientific Opinion will be judged by the same three criteria as for the PIM designation, as well as a fourth criterion: the Company’s ability to manufacture the product to rigorous “GMP” (clinical grade) standards.
Flipper44 and Longfellow95,
Thank you. I found some additional information about the status of dcvax-l in September 2016. It was at that moment NUB Status 2.(Hospital Exemption)
***) NUB-Status 2 means that the product does not fulfill the
requirements for a NUB, Institute for Hospital Fee Systems (InEK) 2016.
**) NUB-Status 4 means that information provided is insufficient
to meet the eligibility criteria for an additional reimbursement according to the NUB procedure.
“NW Bio also announced today that the German reimbursement authority (Institut Fur Das Entgeltsystem Im Krankenhaus, or InEK) has determined that DCVax-L treatments for glioma brain cancers are eligible to obtain reimbursement from the Sickness Funds (health insurers) of the German healthcare system.
Applications for such reimbursement eligibility may only be submitted to InEK by German hospitals, not by a company. Six major hospital centers across Germany applied for such reimbursement eligibility for DCVax-L for glioma brain cancers. The amount and terms for such
reimbursement will now be negotiated by NW Bio, the hospitals and the Sickness Funds over the coming months, and will be applied to patients case by case. In the meantime, patients may self-pay for DCVax-L.” (78).
As was the case for DCVax-L, applications for NUB reimbursement can already start before the ATMP is authorised under the HE. Of note, the centrally authorised ATMPs ChondroCelect” indicated for cartilage repair in the knee, has also so far been reimbursed on a case-by-case basis via
the NUB procedure (76).
Was the hold in Germany initiated by NWBO? How do we know?
I don't know where it was initiated.
Berichte aus Fallserien (Phase-I- und Phase-II-Studien) mit nach Ansicht der Autoren vielversprechenden klinischen Verläufen in diesen nicht kontrollierten Fallserien. Eine wissenschaftlich begründete Aussage zur Wirksamkeit oder Unwirksamkeit der Behandlungsmethode könne auf der Grundlage der genannten Daten nicht getroffen werden. Daher werde seit Jahren eine Phase-III-Studie zur Impfung mit dendritischen Zellen durch die Firma N.-W.-B. (DCVax-Behandlung) durchgeführt, aktuell beim neu diagnostizierten Glioblastom. Diese, mittlerweile abgebrochene, Studie sei im Jahr 2011 aber noch nicht geöffnet gewesen; der Versicherte hätte an ihr nicht teilnehmen können. Die Phase-II-Daten, die Grundlage der Phase-III-Studie gewesen seien, seien bislang nicht veröffentlicht.
Das P.-E.-Institut habe eine aus formalen Gründen für die Durchführung der Studie erforderliche Herstellungsgenehmigung erteilt. Das I. habe der DCVax-Behandlung einen Status 4 vergeben; das seien Methoden oder Leistungen, bei denen die mit der Anfrage übermittelten Informationen i.S.d. Verfahrens nach § 6 Abs. 2 Krankenhausentgeltgesetz (KHEntG) unplausibel oder nicht nachvollziehbar seien.
Basierend auf positiven Daten einer randomisierten Phase-II-Studie zum Nutzen einer Multipeptidvakzine, beladen auf dendritischen Zellen (ICT-107) in der Primärtherapie von Patienten mit Glioblastomen werde aktuell eine randomisierte Phase-III-Studie konzipiert. Für den Erfolg einer Impfstrategie, ob mit oder ohne autologe dendritische Zellen, sei die Auswahl der relevanten Antigene essentiell. Soweit bekannt, seien für die Behandlung des Versicherten keine rational ermittelten und validierten Antigene zur Beladung auf autologe dendritische Zellen verwendet worden. Für die Herstellung dendritischer Zellen existierten keine allgemein etablierten Protokolle, weshalb es nicht ohne Weiteres möglich sei, die Ergebnisse eines Labors bzw. einer Firma mit anderen Ergebnissen zu vergleichen. Die einschlägigen Daten der Praxis seien nicht zugänglich bzw. nicht erhoben worden. Dr. N. sei Co-Autor zweier Veröffentlichungen, in denen bestimmte Phänomene im Zusammenhang mit dendritischen Zellen beschrieben würden, allerdings in vitro; daraus könnten Wirksamkeitsindizien nicht abgeleitet werden. Als einziger immuntherapeutischer Wirkstoff auf der Basis einer dendritischen Zellvakzine verfüge Sipuleucel-T über einen positiven Wirksamkeitsnachweis beim Prostatakarzinom aus einer Phase-III-Studie; die Studie habe bei der Behandlung des Versicherten aber noch nicht vorgelegen. Die im September 2013 erfolgte Zulassung durch die EMA sei im Juni 2015 widerrufen worden; die Gründe hierfür seien nicht bekannt. Generell könne nicht ohne Weiteres von der Behandlung eines Tumors auf die Behandlung eines anderen Tumors rückgeschlossen werden; das gelte für die gesamte Onkologie. Für immuntherapeutische Ansätze, etwa mit Immuncheckpoint-Inhibitoren, die in den letzten Monaten und Jahren große Aufmerksamkeit erfahren hätten und bei bestimmten Tumorarten (z.B. Melanom und Lungenkrebs) eine beeindruckende Wirkung zeigten, sei dies sogar spezifisch festzustellen. Für diese Immuntherapeutika sei der Wirksamkeitsnachweis bei anderen Tumorarten nicht gelungen. Belastbare Daten für Glioblastome fehlten. Das Gehirn sei aber immunologisch gesehen - wobei die dendritische Zelltherapie auf immunologischen Prinzipien beruhe - ein ganz besonderes Organ mit einem besonders immununterdrückenden Gewebeumfeld. Das erkläre, weshalb Erkenntnisse aus Immuntherapien außerhalb des Gehirns keinesfalls ohne Weiteres auf das Gehirn übertragen werden könnten. Zusammenfassend könne daher nicht konstatiert werden, dass für die beim Versicherten durchgeführte Immuntherapie mit dendritischen Zellen eine nicht ganz fernliegende Aussicht auf Heilung oder spürbare positive Einwirkung auf den Krankheitsverlauf bestanden habe.
It is nice to discover that German neurosurgeons (Neurochirurgie im Diakonie Klinikum Jung-Stilling in Siegen) inform their patients about a promising study (DCVAX-L) for the treatment of brain tumors.
I have to admit that the doctors exaggerate a bit with the numbers, unless they are better informed about the German patients in the trial!
Use Google Translate!
March 4, 2019
Tumor-Impfung bei Hirntumor? Informationen aus Siegen
Neurochirurgie aus Siegen informiert zu neuer Studie zur Therapie bei Hirntumor mit OP und Chemo.
SIEGEN. Ein Glioblastom ist ein aggressiver Hirntumor, der in der Regel mit einer Operation und einer anschließenden Chemo- oder Strahlentherapie behandelt wird. Auch in der Neurochirurgie im Diakonie Klinikum Jung-Stilling in Siegen werden Operationen an dieser Form eines Hirntumors unter der Leitung von Chefarzt Prof. Dr. med. Veit Braun durchgeführt. Der medizinische Fortschritt im Bereich der chirurgischen Therapie ist weit. Noch vor zehn Jahren konnten viele Tumoren nicht operiert werden. In modernen Hybrid-Operationssälen wie sie die Neurochirurgie in Siegen nutzt, können Tumoren heute exakter und für den Patienten schonender behandelt werden.
Operation am Hirntumor in Hybrid-Operationssaal: Gute Bedingungen für Patienten in Siegen
Im Hybrid-Operationssaal für die Neurochirurgie in Siegen kann direkt im OP eine Bildkontrolle nach dem Eingriff erfolgen. Die Operation selbst kann über den Einsatz intraoperativer Navigation besser gesteuert werden. Auch eine Unterscheidung zwischen gesundem und malignem Gewebe ist im Hybrid-OP besser möglich. Im Anschluss an die Operation wird je nach Ergebnis der Gewebeprobe und in Abhängigkeit davon, ob der Tumor vollständig entfernt wurde, die weitere Therapie in einem interdisziplinären Ärzteteam geplant. Auch für die Behandlung nach der OP gibt es derzeit hoffnungsvolle Studienergebnisse. So konnten amerikanische Wissenschaftler gute Erfahrungen mit einer Tumor-Impfung machen, die das Immunsystem auf den Angriff durch einen Hirntumor trainiert.
Nach der OP am Hirntumor: Neurochirurgie verweist auf neue Studienergebnisse aus Amerika.
Die noch nicht abgeschlossene Studie konnte zeigen, dass die Teilnehmer nach dem chirurgischen Eingriff plus Chemotherapie mit einem neuen Medikament im Vergleich zur Standardtherapie deutlich länger lebten. Zum Einsatz kam dabei nach OP und Chemotherapie das Präparat DCVax®. Die ersten Studienergebnisse zeigen: Von den 331 Teilnehmern lebten nach der Einnahme des Medikaments etwa ein Drittel länger als drei Jahre nach der Therapie. Nach zwei Jahren waren es 223 Patienten. Bei dem Medikament handelt es sich um einen Impfstoff, der das Immunsystem darauf trainiert, die Tumorzellen anzugreifen. Dabei werden dem Patienten Monozyten aus dem Blut entnommen, die zu dentritischen Zellen entwickelt und mit den Tumorproben des Patienten in Kontakt gebracht werden. Die Zellen sollen so auf den Umgang mit den Glioblastom-Zellen trainiert werden. Sie werden dann wieder in den Körper injiziert und sollen das Immunsystem zum Angriff auf den Hirntumor aktivieren.
Dieser Beitrag wurde unter Hirntumor abgelegt am 4. März 2019.
http://www.neurochirurgie-diakonie.de/tumor-impfung-bei-hirntumor-informationen-aus-siegen/