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trocprofit,
Yesterday, i found the same on the FDA website and i found 2 other requests. One from Richard Fairgrieve (2018) and one from Anthony Schwartz (2017). The status of all 3 requests is “Withdrawn Closed w/o Charges”. (For Frank Mowry: see FDA paper of 1 month ago = status: Withdrawn Closed w/o Charges. Note: there is another request from him dated 05/01/2018)
I suspect that Richard Fairgrieve is a NWBO long. (twitter).I wonder if the other two people are also NWBO long?
UCLA Brain Tumor Center Community Lecture.
Date and Time.
Wed, February 12, 2020
6:00 PM – 8:00 PM PST
Event description:
To start the New Year, you are cordially invited to a special event focused on health. This community lecture, hosted by Julia Post-Gunether, features presentations from the UCLA Brain Tumor Center. Featured speakers include:
• Linda M. Liau, MD, PhD, MBA – Professor and W. Eugene Stern Chair in Neurosurgery; Chair, UCLA Department of Neurosurgery; Director, UCLA Brain Tumor Center; Principal Investigator, UCLA SPORE in Brain Cancer
• Timothy Cloughesy, MD – Professor of Clinical Neurology, UCLA Department of Neurology; Director, UCLA Neuro-Oncology Program; Co-Director, UCLA Brain Tumor Center
• Anthony Wang, MD – Assistant Professor, UCLA Department of Neurosurgery
DATE: Wednesday, February 12, 2020
TIME: 6:00 p.m.
LOCATION: Center Club Orange County, 650 Town Center Drive, Garden Level, Costa Mesa
About the UCLA Brain Tumor Center.
Under the co-direction of Drs. Linda Liau and Timothy Cloughesy, the UCLA Brain Tumor Center is part of a prestigious network of scientists, researchers, and physicians dedicated to delivering the best available treatments for brain cancer, while also working toward a cure. As part of UCLA Health—the No. 1 hospital in California according to the 2019 U.S. News and World Report —the UCLA Brain Tumor Center is one of only six brain tumor programs in the nation to be designated a Specialized Program of Research Excellence (SPORE) by the National Cancer Institute. Unique in its depth and breadth of clinical research, the UCLA Brain Tumor Center is advancing the science of brain tumor treatment, offering research and clinical trials in every aspect of brain tumor care. Efforts include new imaging techniques and innovative cellular therapy treatments, such as a dendritic cell brain vaccine for glioblastoma, the most common and malignant brain tumor.
https://www.eventbrite.com/e/ucla-brain-tumor-center-community-lecture-tickets-86420539159
UCLA NEUROSURGERY
CONNECTIONS
Brain Tumor Edition JUL 2019
GENEROSITY
Family’s $1 Million Gift Fuels the Fight Against Cancer.
“Most glioblastoma patients face a short and hopeless future, but UCLA gave me a sense of relief.”
Jack and Joanne are no strangers to philanthropy: they have supported arts, education, legal services for the poor, minority opportunities, and women’s rights. But their gift to the UCLA Brain Tumor Center, to advance research, came from a deeply personal place.
In February 2018, their son Mac was diagnosed with stage 4 glioblastoma (GBM)—an aggressive type of cancer that can occur in the brain or spinal cord. This terrifying news sent Jack on a quest for answers that might help his son and others fight this fast moving cancer. After receiving the standard of care— surgery, followed by chemotherapy and radiation—Mac’s community of doctors at OHSU Knight Cancer Institute connected the family with the UCLA Brain Tumor Center because of the team’s cutting-edge and comprehensive approach to changing the face and fate of brain cancer.
The family was introduced to Dr. Timothy Cloughesy, Director of the UCLA Neuro Oncology Program and Co-Director of the UCLA Brain Tumor Center. Together with his colleague Dr. Linda Liau, W. Eugene Stern Chair of Neurosurgery and Co-Director of UCLA Brain Tumor Center, the UCLA team is actively researching novel therapies and providing brain tumor patients with advanced, safer and more effective treatment options. Through clinical trials, the UCLA Brain Tumor Center is often one of the first programs to offer promising new treatments and technologies.
The family met with Dr. Cloughesy in October 2018 to learn more about UCLA’s approach and research, and were inspired to learn about the team’s advances in immunotherapy with their dendritic cell vaccine. A dendritic cell vaccine uses the patient’s own white blood cells to activate the immune response to fight cancer. A high percentage of patients enrolled in these trials have survived for several years, which is a much better outcome than the 15 to 17 month average life expectancy of people diagnosed with glioblastoma. Inspired by the potential life-extending outcomes for individuals diagnosed with brain cancer, the family asked Dr. Cloughesy how they could help. Dr. Cloughesy shared that in order to advance research and clinical trials, and thereby potentially extend more lives, the UCLA physician-scientists had to act fast and develop their own vaccine formula in-house at UCLA. The primary hurdle for taking these new therapies from laboratory to patients, “bench to bedside,” is adequate research funding. Impressed with UCLA’s vision and expertise, Jack and Joanne decided to gift $1 million to support the advancement of novel therapies such as the dendritic cell vaccine.
“My decision was influenced by the fact that UCLA is developing the most promising therapy available anywhere,” Jack said, “and its reliance on autologous cells and tailoring of therapy to each individual is very compelling, since each tumor is different and an individualized approach is more likely to succeed. It’s inspiring to so many people that the UCLA Brain Tumor Center is driven by the goals of advancing science and helping patients, rather than commercial considerations.”
For Mac and his parents, learning about the UCLA Brain Tumor Center’s research goals and discoveries has provided a great sense of relief and hope. “Most glioblastoma patients face a short and hopeless future, but UCLA gave me a sense of relief,” said Mac. “When I was first diagnosed, I did not know the seriousness of this condition and its grim survival curve. The fact that UCLA’s research and innovative new therapies show promising outcomes is extremely heartening. This hope is priceless, given the fatigue of fighting cancer.” Jack and Joanne hope that their gift will advance lifesaving research, but they also want to call attention to the unique resources available at UCLA and engender further support for its Brain Tumor Center.
“We cannot overstate the importance of community—of our friends who have done all they can to support our family during Mac’s illness, and UCLA experts who are tied into an international network of researchers working to find a cure for glioblastoma,” said Joanne.
At the moment, Mac is doing well: he climbed Mount Hood in late April. He is cherishing his time, and family more than ever.
http://neurosurgery.ucla.edu/workfiles/Site-Neurosurgery/Newsletters/Neuro-Connections-Newsletter-July2019.pdf
I agree Idunno!
Today i found this article by Bernard Siegel, Founder & Chair, World Stem Cell Summit; Executive Director,Regenerative Medicine Foundation.
The comment by Mark Lowdell is telling!
Article:
Critics: the Eyores in the ecosystem.
Published on December 25, 2019
As we end the year, how many of you have been bothered by critics? I am thinking specifically about the critics in the fields of science and regenerative medicine- but critics are critics, doing their thing- handwringing negativists- quick to tear down but not build up. Eyores in the ecosystem, they are! In the arena of life, we try, we struggle, we do our very best- but there are always the critics. Some have used criticism and online platforms as a catapult to some level of "fame"- newspaper and online pundits- reliable quote machines. Critics often empower themselves- at the expense of those who have "skin in the game." For all those believing they have been unfairly criticized, I present for your consideration these pearls might make you feel a little bit better:
"A critic is a man who knows the way but can't drive the car." English theatre critic, Kenneth Tyson
"Critics are like brushes of nobleman's clothes" English poet, Sir Henry Wotton
"How much easier to be critical than correct" English statesman, Benjamin Disraeli
"Pay no attention to what the critics say; no statue has ever been erected to a critic" Jean Sibelius, Finnish Composer
It's okay to be critical of the critics. But ask yourself, what drives their criticism? Whose side are they on and why? Do they have skin in the game? What's their angle? Most importantly, if the criticism is well-founded, what can you do to substantively answer the criticism, not by your words, but by your deeds?
https://www.linkedin.com/pulse/critics-eyores-ecosystem-bernard-siegel/?trackingId=KYI29YS8TNCMxbm4XHi%2F2g%3D%3D
Comment by Mark Lowdell:
Well said. I know of three APPROVED academic trials stopped and cancelled due to fake criticism by a single blogger - fake news isn't just a political issue.
Hyperopia,
Thank you! Great post!
Gary,
IMO,it's a good thing that the improved L has been incorporated into the trial.(NOTE: I believe the Germans) If not, you could have difficulties in transforming a complex, individualized treatment into a commercial product.
Example : Kymriah (Novartis) and postmarketing requirements (PMR) by the FDA.
Flipper44,
I think that the Germans had a problem with the soc/control group from the moment they were involved in the trial.
European Medicines Agency - 2018
Data Monitoring Committees issues.
Draft questions and answers
https://www.ema.europa.eu/documents/scientific-guideline/draft-questions-answers-data-monitoring-committees-issues_en.pdf
Thank you pgsd! I can't find additional information from others like David Jenkinson who took pictures last year. (Linda Liau presentation SNO2018)
Two interesting tweets IMO: first the mOS for the placebo group in the Randomized, placebo controlled trial of +/- ABT414/“Depatux-M”
and second the side effects after immunotherapy and pseudoprogression.
The Journal of Law and the Biosciences (JLB)
Article:
Assessing the legal duty to use or disclose interim data for ongoing clinical trials.
Published: August 13,,2019
https://academic.oup.com/jlb/article/6/1/51/5549623
I found this job description (Advent Bioservices). It was posted around November 6, 2019. I realize that it is nothing more than a job description but it was the description of the location that caught my attention. (in old)
Article:
Glycan modification of glioblastoma-derived extracellular vesicles enhances receptor-mediated targeting of dendritic cells.
Published online: 09 Aug 2019
https://www.tandfonline.com/doi/full/10.1080/20013078.2019.1648995
This work was supported by the European Research Council [ERC Advanced Glycotreat 339977]; Institute for Chemical Immunology [ICI0011]; Cancer Center Amsterdam [CCA2014-5-18]
Thank you Marzan for the information and congratulation on your investment in AMRN.
Longfellow95,
Thank you for the article (Spark looks at scale, manufacturing as gene therapy matures). I remember reading it a while ago and i think you brought it to my attention then. So, thank you!
I want to emphasize this quote (in bold):
JTORENCE,
My apologies. I couldn't find an English version.
Summary:
Northwest Biotherapeutics BV (BV is an abbreviation for Besloten Venootschap, a private company with limited liability (Founder: Linda Fairing Powers). BV has similar features as the German "GmbH", the American "LLC", or the English "Ltd".)
Address:
Kingsfordweg 151 1043 GR Amsterdam.
On April 25, 2019, the Company established a new wholly owned subsidiary in the Netherlands, where the European Medicines Agency is relocating.”
EMA address: Domenico Scarlattilaan 6, 1083 HN Amsterdam.
The 2 addresses look to be about 6 miles apart.
The new European Medicines Agency offices in Amsterdam were formally opened on Friday, almost two years to the day that the Dutch capital won the race to host the organisation.
Link here: thank you Longfellow95!
https://www.dutchnews.nl/news/2019/11/european-medicines-agency-is-almost-open-for-business-in-amsterdam/
My second link was the address of the office in Germany:
Northwest Biotherapeutics GmbH Deutscher Platz 5, D-04103 Leipzig.
Thank you Biosectinvestor!:
2nd link here: https://nwbio.com/northwest-bio-awarded-5-5-million-german-government-grant-2/
Eagle8,
Info on NWBO subsidiary in the Netherlands:
Kingsfordweg 151 1043 GR Amsterdam
https://drimble.nl/bedrijf/amsterdam/42606225/northwest-biotherapeutics-bv.html
EMA address: Domenico Scarlattilaan 6, 1083 HN Amsterdam. Phone: +31 88 781 6000
NWBO Germany:
NW Bio has made a strategic decision to settle in Leipzig, Germany, and establish its subsidiary there. Leipzig is the second largest city in the State of Saxony, and is the home of Fraunhofer IZI. The State of Saxony, and Leipzig in particular, have put a concentrated focus on regenerative medicine and cell therapies (including immune therapies) for nearly a decade, and have become one of the most important centers for such therapies in Europe. This concentration includes the full spectrum of capabilities and infrastructure, from R&D to specialized hospitals and medical centers to manufacturing. Funding for the grant has been provided by the German Federal State of Saxony and the European Union.
https://nwbio.com/northwest-bio-awarded-5-5-million-german-government--2/grant
Exwannabe,
Marnix Bosch uses a semi-colon in his presentation. The two (OS and LTFU) are linked to each other.
IMO, Linda Liau makes the same error in here presentations and interviews when she talks about the first tail of 50% of the patients in both groups ( the placebo and the treatment group) and the separation of the OS curves.
NOTE: think of the mesenchymal GBM subgroup.
CANCERCAN.BLOG - June 2018
Touching Minds: A Brain Surgeon & Scientist on Cancer.
start around 49.30 min.
https://cancercan.blog/liau/
Longfellow95,
The next speaker is Harriet Kluger, MD
https://www.sitcancer.org/2019/program/annual-meeting-schedule-2019-old
5:35 p.m.
Immunobiology of CNS Metastatic Tumors
Harriet M. Kluger, MD – Yale School of Medicine
Biography
Dr. Kluger is a medical oncologist who sees patients with melanoma and renal cell carcinoma. Her research interests focus on developing new drug regimens and biomarkers predictive of response to therapies in melanoma and renal cell carcinoma. She participates in a number of clinical trials studying new agents for the treatment of these diseases, both targeting the immune system and the cancer cell. She runs an active research laboratory that studies tumor and immune cells from patients treated with novel therapies to determine mechanisms of resistance to therapy and mediators of toxicity from immune checkpoint inhibitors. The laboratory also conducts pre-clinical studies to improve treatment regimens for patients with melanoma, renal cell carcinoma or brain metastasis.
https://www.yalecancercenter.org/profile/harriet_kluger/
SITC 2019 NOV 6-10
Saturday, Nov. 9, 2019
Concurrent Session 311: A Tale of Two Brain Tumors: Primary versus Metastatic CNS Tumors
5:15 p.m.
Immunobiology of Primary CNS Tumors
Robert Prins, PhD – University of California, Los Angeles
https://www.sitcancer.org/2019/program/annual-meeting-schedule-2019-old
Interesting summary of policies across Europe for timely access of ATMPs. Table 8 shows which approved therapies are reimbursed in each country. Sweden's TLV says due to high uncertainty more follow up is needed for Kymriah, Luxturna, Yescarta and Alofisel.
HTA; health technology assessment (HTA)
European HTA recommendations for ATMPs available as of June 2019.
Advanced Therapy Medicinal Products (ATMPs) include cell therapies, gene therapies, and tissue engineered products.
As of June 2019, 14 ATMPs have been granted marketing authorization in Europe (2): seven gene therapies, three cell therapies, and four tissue engineered products. Marketing authorizations for the first four approved ATMPs have been withdrawn by their sponsors for commercial reasons.
To date, Germany is the country with the highest number of ATMPs that are or were reimbursed, with a total of six, four of which are still on the market. NICE England recommended the reimbursement of five, all of them currently available to patients. Four ATMPs were recommended for reimbursement by HTA bodies in France, while in Italy three are reimbursed and currently available to patients. Only one product was reimbursed in Spain before its withdrawal and no ATMPs have been reimbursed in Sweden.
https://heatinformatics.com/posts/review-atmp-hta-reports
See the full report here: https://heatinformatics.com/sites/default/files/images-videosFileContent/ARM-Market-Access-Report-FINAL.pdf
Longfellow95,
I remember that you brought Mark Lowdell to our attention. ( IMO 2 or 3 years ago?)
Since that day i follow him closely. So thank you, thank you for your great work!
And i agree, Mark Lowdell is amazing!
I am so proud we have Mark and not Adam!
hm...Sweden
CAMP SWElife
GUIDING ATMPS TO PATIENTS
Here you will find information on what is happening in Sweden in development of medicines based on genes, cells or tissue engineering, classified as Advanced Therapy Medicinal Products (ATMPs) in Europe. We welcome your collaboration towards accelerated and effective patient solutions.
https://atmpsweden.se/#
Mark Lowdell joins CAMPs International Advisory Board
CAMP is very pleased to announce the addition of Mark Lowdell to our International Advisory Board! Mark joins Karin Hoogendorn and Michael May in the IAB and brings with him a plethora of experience in immunotherapies, academic ATMP manufacture and tissue engineering.
Mark is the Director of the centre for Cell Gene and Tissue Therapeutics at the Royal Free Hospital in London. He is a QP, has extensive knowledge in immunology and immunotherapy applications and has a passion for forward thinking ATMP manufacturing strategies.
https://mailchi.mp/4353aed09fcb/swedish-atmp-newsletter-october-2019
Flipper44,
Thank you. Good summary.
I agree that the use of 5-ALA-FIGR (Topical 5-aminolevulinic acid - Fluorescence image guided surgical resection.) is a good tool for improving the immunogenicity of cancer cells (Immunogenic apoptosis and the exposure on the plasma membrane of DAMPs = Damage associated molecular pattern) to use them as an antigen cargo in the development of dendritic cell (DC) vaccines.
I wonder if Fraunhofer improved the manufacturing process to obtain a more immunogenic DCvax-L?
I hope that a DCvax-L that is more immunogenic can induce an immunostimulatory shift in the brain immune environment, leading to reduced numbers of regulatory T cells and increased prevalence of Th1, CTLs, and Th17 lymphocytes. Anyway that's what Hyp-PDT-TCL-loaded DC vaccines do.
hypericin-based photodynamic therapy (Hyp-PDT)
tumor cell lysate (TCL)
regulatory T cells (also called Tregs) are T cells which have a role in regulating or suppressing other cells in the immune system.
Cytotoxic T lymphocyte (CTL)
T helper cells (Th cells) = a type of lymphocytes that play an important role in the immune system.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5855816/
Thanks Flipper!
Indeed, during the surgery, Dr. Sloan uses a specially adapted surgical microscope that can illuminate the tumor with either white or blue light.
Flipper,
Thank you for the information. It is believed that Topical 5-aminolevulinic acid mediated photodynamic therapy (ALA-PDT) can induce anti-tumor immune responses through dangerous signals damage-associated molecular patterns (DAMPs).
I agree that the use of DCvax-L in combination with ALA-PDT seems promising.
I believe the European surgeons mainly used 5-ALA induced FIGR.
FIGR = Fluorescence image guided surgical resection.
IMO not many patients (DCvax-L trial) had Photoferin repetitive photodynamic therapy (rPDT) in addition to 5-ALA-FIGR,
Article:
5-ALA Fluorescence Image Guided Resection of Glioblastoma Multiforme: A Meta-Analysis of the Literature.
https://www.mdpi.com/1422-0067/16/5/10443/htm
Article:
5-ALA in the management of malignant glioma.
Fantastic news:
Update Laura Nuttall (GBM -multiple brain tumours-unmethylated- wild type -surgery Nov.7 2018 - started immunotherapy treatment (not DCvax-l) at the IOZK clinic Cologne - Germany).
Nicola Nuttall:
All day today I’ve had to wear my dress back to front and Gracie had her lucky knickers on but IT WORKED !!! The scan continues to be clear and oh my goodness are we relieved!!! We can breathe out, at least for the next 3 months anyway. @BrainTumourOrg @BBCNWT pic.twitter.com/aKanHrRrsl
— shitscaredmum (@shitscaredmum) October 11, 2019
As it’s #EyeWeek just wanted to thank @bootsopticians @westfieldlondon who back in October spotted pressure behind Laura’s eyes which on further investigation showed multiple brain tumours. A quick diagnosis can make all the difference @HeadSmartUK @BrainTumourOrg pic.twitter.com/kSRw86gISw
— shitscaredmum (@shitscaredmum) September 26, 2019
Scotty,
Thanks.
And still tumour free thanks to DCVAX!
Kat's cure : posted 1 hour ago.
https://scontent-bru2-1.xx.fbcdn.net/v/t1.0-9/71776218_1305688469613441_7234994795205099520_n.jpg?_nc_cat=103&_nc_oc=AQn3P5rxDoBNOYVo3bc8mbyfxz7C04aBnW337snQ_y72hhCq5LXT6FwIXLqpq5Nsr9-b_mgG-Jk52F8v5uKtJD8H&_nc_ht=scontent-bru2-1.xx&oh=5516661867715d8a2605e98f8a97b0cb&oe=5E3A22A4
https://www.facebook.com/katscure/
longfellow95,