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congrats that's great. Monday should be a interesting day.
Thank you Sojo. I concur...Enjoy the weekend.
Sojo..... seems like a buying day today.. marz?
ty I know. its more for the others to see from you
SOJO !!!! What do you see friend...
gotcha. I was trying to see if you saw something about to happen. last time you posted we did take a large jump up in price. hopefully 10 again
salt of the earth
Yes we do.
Picked up 50k more.
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Northwest Biotherape (NWBO)
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The Dark Side Of The Electric Vehicle Boom
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sentiment_stocks Member Level Monday, 06/11/18 01:12:53 PM
Re: None 0
Post # of 367741
Kristyn Power - father diagnosed with GBM - minute 27:00 - ASCO 2018 presentation
Hello. My name’s Kristen Power and I’m from Canada. In July 2014, we received the terrifying news that my dad was diagnosed with GBM. At that time, he started radiation and he was able to comply radiation, but he wasn’t able to tolerate chemo. So because of that, he had another recurrence in the Spring of 2015. In 2015, there weren’t a lot of treatment options because of his inability to take chemo. In October, following his complete resection in June [2015], he had another recurrence. At that time, we fought for a third surgery, and they were able to resect 70% of the tumor. 30% of the tumor remained, and it was a fast growing tumor. We were told that he likely had about two weeks to live. We contacted Northwest and we were able to obtain the vaccine compassionately because we preserved the tumor tissue, and he started treatment. Today, my dad is almost four years out from diagnosis. He continues to be stable. He’s improving. If we look at his cognitive function, his conversations are improving, his physical mobility is improving, and everything is looking really good. We’re really, really grateful for how Northwest has treated us. They treat as almost part of the family. They answer the phone, they answer all of our questions, they’ve been amazing. I think that’s it. Oh, when dad was diagnosed, he was in his sixties. So, that’s one of those negative prognostic factors.
So he was over sixty, he didn’t have a complete resection, he wasn’t able to take chemo, he had a fast growing tumor, and he’s still doing good.
[Kristen forgot to mention that her father was recurrent GBM as well.]
That’s our experience.
good question. what does it tell us
that's good
this could blow up something is moving it all over. sojo any thoughts?
Maybe that was Adam’s April fools day joke. 4/1. If we all know they know as well. The question will be who is behind him Adam is just a mouth piece nobody.
I really don't like that guy.. However I will thank him for the cheap shares. one day I wouldn't mind opening a bottle of his favorite wine over his head...
great job. ty
New Medicines
DCVax-L · Newly diagnosed glioblastoma multiforme
Information
Trade name
DCVax-L
Entry type
New molecular entity
Company name UK
Northwest Biotherapeutics
Company name US
Northwest Biotherapeutics
Development and Regulatory status
UK developmental status
Phase III Clinical Trials
EU developmental status
Phase III Clinical Trials
US developmental status
Phase III Clinical Trials
Orphan Drug EU
Yes
Comments
Jun 20 · NW BIO is also developing new and expanded facilities for manufacturing in Sawston for the UK and the European market [27].
Apr 19 · Northwest Bio are in the process of finalising agreements with Advent BioServices for manufacturing of DCVax products in the UK, with the intention to manufacture DCVax products for the whole European region. Northwest Bio has yet to apply for fast track status in the US [25].
Apr 16 · Northwest Bio plans to apply for fast track status in the US [19].
Apr 16 · In their 2015 annual report, Northwest Bio highlight that it will be necessary to greatly scale up the volume of manufacturing if DCvax-L is approved, far above the level needed for the trials. To their knowledge, no such products have successfully completed the necessary scale-up for commercialisation without material difficulties. For example, Dendreon Corporation encountered substantial difficulties trying to scale up the manufacturing of its Provenge® product for commercialization [18].
Apr 16 · Northwest Bio has entered into an agreement with King’s College London to manufacture DCVax for their clinical trial and compassionate use cases. Cognate BioServices will manage and supervise the processing [18].
Apr 16 · PIII study is still ongoing but no new patients are being recruited. Northwest Bio states that it is having ongoing dialog with regulators, and is providing further information [18].
Aug 15 · Northwest Bio suspend screening of new patient candidates for a PIII trial of DCVax-L for newly diagnosed glioblastoma multiforme (GBM) while it submits certain information from the trial for regulatory review [18].
Sep 14 · The PIM designation covers treatment of malignant gliomas, including the most severe form Glioblastoma multiforme, as well as newly diagnosed and recurrent cases [15].
Sep 14 · UK MHRA awards DCVax-L the first ever ´Promising Innovative Medicine´ (PIM) designation, marking the first step in the Early Access to Medicines Scheme (EAMS), the UK’s new fast-track access programme [15].
Apr 13 · Northwest Biotherapeutics announce that the PIII trials for Glioblastoma multiforme have been "adopted" as a national priority trial in the UK, under the "adoption" program managed by the National Institute for Health Research (NIHR) [12].
Jan 11 · Northwest Biotherapeutics will be able to petition the FDA for accelerated approval if the PII glioblastoma multiforme trial generates results consistent to those obtained from previous trials [8].
Dec 07 · An MAA was filed with Swissmedic in Switzerland. The company believes it has fulfilled its commitments & as of Jun 10, review of the MAA was ongoing. No development reported elsewhere in Europe [8].
Jul 07 · Company plans to file for approval in both the US and EU in early 2009, based upon the results of a pivotal PII trial of 141 US pts, planned to conclude in Dec 08 (1).
Jul 07 · DCVax-Brain authorised for use in selected Swiss cancer clinics for glioblastoma by the Swiss Institute of Public Health (1).
Jul 07 · DCVax-Brain granted orphan drug status in EU (1).
Category
Pharmacology
A vaccine prepared using the pts dendritic cells & cells taken from their surgically resected tumour (1)
Epidemiology
In England and Wales, about 1,860 gliomas are diagnosed each year (2), of which 740 to 840 are GBM (grade 4 glioma) (3). Median survival is 11 mths (4).
Indication
Newly diagnosed glioblastoma multiforme
Methods of administration/route
Intradermal
Further information
In NICE timetable
Yes
When
To be confirmed
Note
Go to latest from NICE
Trial or other data
Oct 20 · NW BIO announces that the database for the PIII trial of DCVax®-L for gliobastoma has been locked, allowing independent statisticians to have access to the unblinded raw data. The statisticians will proceed as quickly as possible with analyses of the raw data and prepare summaries of the trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, who will analyse the data with the statisticians in preparation for public announcement and scientific publication [26].
Nov 18 · Updated blinded interim data from a PIII trial (NCT00045968 ) of 100 patients showed the median overall survival from surgery of 40.4 months (95% Cl: 35.5-46.5) in 2017 and 58.4 months (95% Cl: 45.9-94.5) in 2018. In ITT population of 331 patients, a median survival of 23.1 months from surgery was reported for both 2018 and 2017 data. Updated 2018 data showed that the survival rate at first, second and third year were 89.3%, 46.4% and 28.2%, respectively. In 131 patients with methylated MGMT gene status, median survival was 35.1 months from surgery and 19.8 months for patients with unmethylated MGMT gene status. The survival rate at first, second and third year were 94.6%, 66.6% and 49.1% in patients with methylated MGMT gene status. In patients with unmethylated MGMT gene status, the survival rate was 56.4%, 32.6% and 14.3% for the first, second and third year, respectively. The corresponding standard-of-care (SOC) median survival value was 15-17 months. In 131 patients with methylated MGMT gene status, median survival was 34.7 months from surgery, while standard of care value showed a median survival of 21.7 months. In 162 patients with methylated MGMT gene status, median survival was 19.8 months from surgery, while standard of care value showed a median survival of 12.7 months. Overall, a particularly extended median survival of 40.5 months post-surgery was displayed by the top 100 patients (30%) of the total 331 patients. This extended survival was not fully explained by known prognostic factors including age younger than 50 years, methylated MGMT gene status and complete resection (surgical removal) of the tumour. Only 8% of these 100 patients had a favourable status on all three of the prognostic factors. At the time of analysis, out of 223 patients who crossed 30 months following surgery, 67 (30%) lived 30 months and displayed Kaplan-Meier (KM)-derived median survival estimate of 46.5 months. Also out of 182 patients who crossed 36 months following surgery, 44 (24.2%) lived 36 months and displayed KM-derived median survival estimate of 88.2 months [24].
May 18 · Preliminary data from NCT00045968 suggests it is feasible and safe, and may extend survival [23].
Dec 17 · Company completed a $US12 million financing to fund operations and to expand support the ongoing PIII trial in newly diagnosed Glioblastoma multiforme [22].
Feb 17 · FDA lifts the partial clinical hold on PIII trial. With Northwest Bio having decided to close enrollment 17 subjects short of its target, the lifting of the partial clinical hold will not trigger renewed recruitment in the trial. But the FDA action clears a regulatory concern for Northwest Bio. The study has passed its threshold of 248 disease-progression events—the primary endpoint—and is nearing the 233 patient deaths that need to occur before it starts analyzing the overall survival secondary endpoint. Northwest Bio thinks it will take several months for the trial to reach the overall survival threshold, and that the routine checks and cleaning that are performed before the database is closed will be a multi-month process. As such, it is unclear when Northwest Bio will present data from the trial [21].
Dec 16 · Northwest Biotherapeutics announces that 331 of the planned 348 patients have been enrolled in the PIII trial, and that data “events” have been accumulating towards the endpoints of the trial. The company had estimated that the numbers of “events” to reach the main endpoints of the trial may be reached in Nov 16. Since the summer of 2015, the trial has been subject to a partial clinical hold, only on recruitment. As a result of the partial hold, the trial has not enrolled the last 17 of the total 348 patients. To date, the regulators have not agreed to remove the partial hold, but have allowed all of the patients in the trial to continue being treated in accordance with the protocol. The company is pursuing ongoing dialog with regulators. The company is no longer seeking to enrol the last 17 of the 348 patients and instead focus on accumulation of “events” necessary for the trial endpoints. When sufficient events have accumulated, the process of moving toward data lock and analysis of the data will begin [20].
Apr 16 · Northwest Bio does not know what will happen with the partial hold of its PIII trial, whether it will be released from the screening hold and complete planned enrollment. There is also some possibility that changes requested by the FDA and/or other regulators could complicate the application process for product approval [18].
Mar 16 · PIII trial is on partial clinical hold for screening of new patients for further enrolment; however, over 300 of the planned 348 patients had been enrolled in the trial as of December 31, 2015, and the patients already in the trial have continued to be treated in accordance with the trial protocol, without interruption [18].
Jan 16 · Estimated completion date for the PIII NCT00045968 study is Sep 16 [17].
Mar 15 · Encouraging survival data on 51 GMB cancer patients treated with DCVax®-L. The data showed substantially longer than expected survival in patients with apparent early progression (recurrence) of their cancer, including those with such aggressive cancer that the tumor was already re-growing by the end of 6 weeks of daily radiotherapy and chemotherapy after surgical removal of the original tumor. Median OS of the 51 Information Arm patients as a whole was 18.3 months; about 30% lived beyond 2 years, and most of these patients (12 of the 15) remain alive. These 51 GBM patients were treated in an Information Arm outside the Company´s PIII l trial asthey were not eligible for the trial, due to evidence of early tumor re-growth following 6 weeks of daily radiotherapy and chemotherapy which are standard of care. [16]
Jun 14 · PIII NCT00045968 study is currently recruiting pts. Collection of primary outcome data should be completed in Sep 14 [14].
Mar 14 · The Data Safety Monitoring Board (DSMB) has made an unblinded review of the safety data for the ongoing international PIII GBM Trial, and has recommended that the trial continue as planned. [13]
Mar 13 · Northwest Biotherapeutics anticipates completing enrollment of its PIII trial by Q1 or early Q2 of next year, and expects to reach its first interim analysis for efficacy by approximately Q3 of this year [11].
Aug 12 · Northwest Biotherapeutics has received approval from the MHRA for the Company´s PIII trial of DCVax-L to proceed in the UK. The trial is already underway at 40+ sites in the US. The trial has been approved by the UK National Research Ethics Committee. The study (NCT00045968) is enrolling 300 patients with newly diagnosed GBM for whom surgery is indicated. Patients must enter screening at a participating site prior to surgical resection of the tumour. They will receive the standard of care, including radiation and temozolomide therapy and two out of three will additionally receive DCVax-L, with the remaining one third receiving a placebo. Patients randomized to the placebo arm will have the option to receive DCVax-L in a crossover arm on documented disease progression. The primary endpoint is progression free survival. Overall survival is a secondary endpoint. Historically patients with newly diagnosed GBM show a median time to progression of about 8-9 months with median survival of 15-16 months. Immunization starts following primary therapy and will be given at weeks 0, 2 and 4 and at months 2, 4, 8 and 12, 18, 24 and 30.?The study started in Dec 2006 and primary outcome data are expected by Jun 13 [9,10].
Jan 11 · Company announced that it is resuming enrollment into its ongoing 240-patient, double blind, randomized, placebo controlled PII trial for Glioblastoma multiforme. 33 patients had already been enrolled and continue to be treated with the vaccine. The trials stalled due to financial pressures [7].
Aug 10 · Further long-term follow-up data from PI and I/II trials reported. The data to July 1, 2010, show that no patients died during the 9-month period since the last update (Sep 09). Median survival is 3 years with 33% of patients reaching 4-year survival, and 27% reaching or exceeding 6-year survival (up from 22% who had reached or exceeded 6-year survival as of the last update). The longest surviving patient has now exceeded 10 years[6].
Oct 09 · The company has announced further long-term follow-up data, for the period from January through September 2009, from its prior PI and PI/II trials. During the update period, only 1 of the 20 patients died, and that patient had survived for 80.5 months. The median survival time in the DCVax-Brain trials is 36.4 months vs 14.6 months in historical controls. 22% of the patients treated with DCVax-Brain have survived for 5-years; with standard care, <5% of patients are alive at 5 years [5].
Jul 09 · It is intended that DCVax-Brain is used as an adjuvant to primary surgery, carmustine or temozolamide (3).
Jul 09 · The 10-day manufacturing process produces several yrs of personalized vaccine for the pt. DCVax-Brain is administered as an intradermal injection in the arm or thigh (1).
Feb 09 · Long-term data from PI/II trials showed that none of the 20 pts with GBM treated with standard of care plus DCVax-Brain died. To date, 68% of pts have lived >2 yrs, 63% have lived >2.5 yrs, 53% have lived >3 yrs, 35% have lived >4 yrs and 25% have lived >5 yrs. In contrast, pts who received full standard of care (surgery, radiation & chemotherapy) without DCVax-Brain have a median survival of 14.6 mths, and <5% are typically alive at 5 yrs. Two of the 20 pts who received the vaccine experienced progression (recurrence) of their brain cancer. Results showed that 95% of DCVax-Brain treated pts have lived longer than the median survival of 14.6 mths with existing standard of care treatment. Likewise, 95% of DCVax-Brain treated pts have been free of disease progression (recurrence) for longer than the median progression free survival of 6.9 mths with existing standard of care treatment (1).
Evidence based evaluations
NICE scope
NIHR
needs new tires
the best I was able to get was 1.34.
tried for 75. only got 30. moved away from me fast
ty. all day everyday 7 plus years.
tell Adam go get his shine box
Thats the tell for sure. when Adam BSstien comes out you know. they have their dirty little hands caught in the cookie jar. Linda is getting ready to lay down the pain
yeppa. ty. next run coming.
yes quick is correct. we went hard after it wouldn't fill all. take what we can get and will be watching and waiting. thank you the cheaper shares AGAIN....
thoughts?
we picked up shares.
you are so predictable
Thats great. ty.
nice. let him know we are all pulling for him. great job sir
thank you
did you see that on level 2. something moving fast just now
FDA APPROVES NOVEL CAR T-IMMUNOTHERAPY FOR THE TREATMENT OF MULTIPLE MYELOMA
By Lee Greenberger, PhD, Chief Scientific Officer at LLS | March, 2021
Chimeric Antigen Receptor (CAR) T cell-therapy is on a roll. Today marks the seventh approval of CAR T therapy since the first approval in 2017. While all prior approvals with CAR T have directed the engineered T-cells to CD19, a marker on the surface of malignancies derived from B-cells, this is the first approval of a B-cell maturation antigen (BCMA)-directed CAR T. Idecabtegene vicleucel or ide-cel (Abecma) is the first approval of a CAR T for multiple myeloma. This approval comes on the heels of two new indications for CD19-directed CAR T: axicabtagene ciloleucel (Yescarta®) to treat resistant forms of indolent non-Hodgkin lymphoma, as well as the first approval of new CD19-directed CAR T, lisocabtagene maraleucel (Breyanzi®), for resistant forms of aggressive non-Hodgkin lymphoma.
LLS takes special pride in FDA approvals for CAR T therapies. Our initial investment in CAR T in the 1990’s, when CAR T, and indeed immunotherapy to treat cancer was in its infancy, has turned into a game-changing therapeutic giving new hope to patients with limited treatment options and often very poor prognoses. Through LLS academic grants and our Therapy Acceleration Program® (TAP) investment in biotechnology companies of over $50M in the past 30 years, LLS has been instrumental in bringing four CAR T-therapies to patients: axicabtagene ciloleucel (Yescarta®), tisagenlecleucel (Kymriah®), brexucabtagene autoleucel (Tecartus™) and liso-cel (Breyanzi®).
CD19-directed CAR T therapy is now approved to treat a range of B-cell malignancies including childhood B cell acute lymphoblastic leukemia and adult large B cell lymphoma, primary mediastinal large B cell lymphoma, mantle cell lymphoma and follicular lymphoma. These therapies have provided significant complete response rates that can last for years. The therapy may actually eradicate the disease yielding cures; the duration of the effect is still being evaluated as some patients have been cancer-free for nearly a decade.
Ide-cel is the first CAR-T that targets a different protein
Ide-cel works by targeting a protein called BCMA that plays a key role in multiple myeloma. The FDA approval was based on results from the phase 2 KarMMa study, which treated 127 patients with advanced forms of multiple myeloma. While multiple myeloma care and outcomes have improved, the disease remains incurable and patients like the ones in the KarMMa study, whose cancer has progressed despite treatment with at least three previous therapies, face poor survival rates.
The majority (72%) of patients in the trial partially or completely responded to ide-cel treatment, with 28% having a complete response—disappearance of all signs of multiple myeloma. Among those with a complete response, 65% remained in complete response for at least 12 months. The known side-effects for CAR T therapy were reported for ide-cel with marked cytokine release syndrome (CRS) and CAR T cell-associated neurotoxicity, occurring in 85% and 28% of patients, respectively, both of which were usually transient.
Multiple myeloma is most common among older patients who also face the worst prognosis and often have limited treatment option. Ide-cel was similarly effective in patients 65 and older, and even in those 70 and older, as it was in the overall study group. Perhaps most importantly, patients treated with ide-cel had improved quality of life. They reported meaningful improvements in most symptoms and their ability to perform day-to-day functions.
About multiple myeloma
Multiple myeloma is a cancer derived from a specialized type of white blood cell called a plasma cells. Such malignant cells proliferate uncontrollably leading to impairment of normal blood cell function, and in advanced cases leads to kidney impairment and bone destruction. While the disease is considered incurable, and the relative five-year survival rate for patients diagnosed with multiple myeloma in the US is approximately 50%, the addition of multiple new FDA-approved therapies to treat the disease are likely to increase overall survival rates in the future.
In 2021, there were 34,920 new cases of multiple myeloma associated with 12,410 deaths in the US. This accounts for approximately 20% of all new cases and deaths from blood cancers in the US. Myeloma is the second most common blood cancer in the U.S. and the most prevalent among African Americans. It is also the hematologic malignancy with the greatest racial disparity in incidence and prevalence; Blacks are not only at twice the risk of developing this rare and incurable cancer when compared to white Americans and other ethnic groups, they are also more likely to be diagnosed at a younger age.
In response to these inequalities, LLS launched a national outreach program in 2017 called “Myeloma Link” to educate African Americans about myeloma, and to help patients access optimal care, and navigate the treatment landscape more effectively.
LLS is looking to the future for better myeloma care and improved CAR-T options
While today’s approval is a step forward, we believe blood cancer is curable and we pledge to be unstoppable in our quest. We have 22 currently active grants focused on multiple myeloma supporting world-class researchers studying a range of novel treatment options.
We also support the power of partnerships. LLS Specialized Center of Research (SCOR) grants are designed to bring together established investigators to foster new interactions and cooperation to speed development of innovative strategies and approaches to blood cancers. In January 2020, LLS activated two SCOR grants investigating the use of CAR-T in multiple myeloma, to Carl June M.D., at the University of Pennsylvania and Madhav Dhodapkar MBBS, at Emory University in Atlanta, investing a combined $7.5M into their promising research.
LLS has also been at the forefront of CAR-T research and that is where we remain. Our current focus is on research to make CAR-T available for more types of cancer, by expanding the proteins targeted, and to make it less costly and quicker to administer. To speed the process and lower costs, LLS-funded researchers are working on “off the shelf” CAR T-therapies that use donor T cells instead of having to harvest and re-engineer each individual patient’s T-cells before reinfusing them.
We are also supporting research into immunotherapies using other parts of the immune system—beyond T cells—to express the Chimeric Antigen Receptor that gives CAR its name. Researchers are finding new ways to add the CAR receptor, which helps immune cells find and kill cancer cells that use natural killer (NK) cells or macrophages. These cells may provide longer lasting anti-tumor activity than traditional CAR-Ts and may also be useful for treating diseases beyond cancer.
We often connect one name to major scientific discoveries. Alexander Graham Bell and the telephone or Thomas Edison and the light bulb, among many others. But the reality is that medical breakthroughs are almost always based on years of research, collaboration, information sharing, and stepwise clinical trials that test the safety and efficacy of novel and re-purposed treatments over years. LLS has been committed to this process for more than 70 years, but today we’re also finding ways to speed it up, and the pace of new immunotherapies is proof of our—and the entire field’s—success.
Myeloma
PRINT
Dear ,
We have exciting news to share. On March 26, the U.S. Food and Drug Administration (FDA) approved a new CAR T-cell immunotherapy, the first of its kind for treating multiple myeloma.
Myeloma is the second most common blood cancer in the U.S. and is most common among older patients who often face the worst prognosis and have limited treatment options. This new therapy, called idecabtagene vicleucel or ide-cel, works by targeting the B-cell maturation antigen (BCMA) protein, which plays a key role in multiple myeloma. This is the first approval of a BCMA-directed CAR T-cell therapy. Studies show promising efficacy and, importantly, improved quality of life among patients treated with ide-cel.
The Leukemia & Lymphoma Society (LLS) is proud to have supported CAR-T research since the 1990s. Over the past 30 years, LLS has contributed $50 million toward bringing CAR T-cell therapies to patients. Our current focus is on research to make these therapies available for more types of blood cancers.
While new FDA-approved treatments will revolutionize multiple myeloma care and outcomes, the disease remains incurable. At LLS, we pledge to be unstoppable in our quest for cures. Learn how our research leads the way, and be sure to check The LLS Blog for the latest updates and inspiring stories.
thank you
Locked and loaded. If it goes there we will be ready Watch all day every day.
added today a little 1.47. holding and adding dry powder waiting
Hello... Thank you from the rest of us.... this guy is clueless. scam artist.