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Sentiment,
We can verify it mathematically.
MGMT+ = 131/293 = 44.7%
MGMT- = 162/293 = 55.3%
3-year survival rate MGMT+ = 46.4%
3-year survival rate MGMT- = 11.0%
Group of 182 patients – 38 “unknown”patients = 144 patients.
144x44.7% = 64 MGMT+ patients.
3-year survival: 64 x 46.4% = 30 MGMT+ patients
144x55.3% = 80 MGMT- patients.
3-year survival: 80 x 11% =8.8 = 8 MGMT-patients
44-30-8= 6 patients from the group of 38 "unknown" patients.
Meirluc,
IMO 30 of the unknown 38 patients died before they reached 36 months on trial. (30 step downs between 0 and 36 months)
2 of the unknown patients are censored. (censor 4 and censor 46).
I believe censor 4 is LTFU. Censor 46 could be still alive at the time of the analysis or LTFU if the patient was one of the first contingent. Total: 30 died and 2 censored= 32.
I believe 207 patients died before 36 months and only 5 or 6 beyond 36 months. That means 10 or 11 LTFU.
I read the PR of 29 May again.
Cognate BioServices Employee Reviews
Manufacturing Supervisor (Current Employee) – Memphis, TN – August 5, 2018
PROS -
This company is on the bleeding edge of CMOs in that we have the equipment and knowledge to produce some of the most interesting and efficacious drugs available. Lots of involvement at the Phase 1, 2 and 3 stages allow employees to become more competent in cGMP and cGDP than would be normal.
Pros
High concept immunotheraputic production, paid insurance, nice leave structure, good place to gain experience in the industry, with patience
https://www.indeed.com/cmp/Cognate-Bioservices/reviews
National Academy of Medicine Elects 85 New Members
http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=10152018
Newly elected regular members of the National Academy of Medicine are:
"Linda M. Liau, M.D., Ph.D, M.B.A., W. Eugene Stern Professor and chair, department of neurosurgery, David Geffen School of Medicine, University of California, Los Angeles.
For achievements in understanding the immunology of malignant brain tumors and designing clinical trials of dendritic cell-based vaccines for glioblastoma."
Meirluc,
All my numbers are mathematical and come from the publication, the great work of Sentiment, my own method to analyze the OS curve and of course it’s all my opinion.
I believe I found one more censor on the OS curve = patient still alive at the time of the analysis.
It’s a methylated + patient.
Meirluc,
Look at the patients who got surgery between 18 and 24 months at the time of the analysis:
IMO,
44 patients got surgery, probably 41 treatment and 3 placebo.
40 patients of this group of 44 still alive at the time of the analysis. (March 2017 and look at Sentiment OS Curve)
Of this group:
21 methylated + still alive. Probably not one of the meth+ has died at the time of the analysis.(21 patients = 47.7% of 44 patients)
18 methylated- still alive at the time of the analysis.(18 patients = 40.9% of 44 patients)
1 unknown still alive at the time of the analysis.(2.2%)
Don’t worry!
Do you know another group of 44 patients with Glioblastoma Grade IV who do better?
Publication:
"MGMT status and extent of resection
In patients with methylated MGMT (n=131), mOS was
34.7 months from surgery (95% CI 27.0–40.7), with 2 and
3-year survival rates of 66.7% and 46.4%, respectively. In
patients with unmethylated MGMT (n=162), mOS was
19.8 months from surgery (95% CI 17.9–21.7), with 2 and
3-year survival rates of 32.1%, and 11.0%, respectively.
Exwannabe,
You write:
October 2, 2018
martino sclavi
@Sclavicus
producer, writer, pescatarian cook and a strange relationship with Cancer - Glio Blastoma Multiforme.
Yesterday I received the positive results of the MRI. And it seams that I am part of the New Cancer battle
@NobelPrize@dendritic_cell@HHSvaccines
Yesterday I received the positive results of the MRI. And it seams that I am part of the New Cancer battle @NobelPrize @dendritic_cell @HHSvaccines https://t.co/2CepgGg6Kt
— martino sclavi (@Sclavicus) October 2, 2018
May 16, 2018
Yes, I am aware that glioblastoma multiforme (GBM), is the most aggressive cancer that begins within the brain (the evil hero). And sadly, what just about every website that I find on Google says is that despite maximum treatment, the cancer usually recurs and that the most survival following diagnosis is 12 to 15 months, with fewer than 3% to 5% of people surviving longer than five years. But I am still alive after 6 years. And, as my oncologist today made me understand it might not be due to my 5 years of very expensive drugs Themodal that has been really keeping me alive.
In fact, what that top oncologist here in Italy told me Today is that the main reason why I am still alive might be that 6 years ago, I took part of a Dendritic Vaccine experiment.
May 31, 2018
So, when I think of maybe trying out new types of cures that have not entered the mainstream I do ask a scientist like Bianca to check out the basic philosophies that follow them. Meditation for example can be seen as a part of a religion or, ultimately just a good healthy exercise. In fact, this morning as I attempted to use the rather weak wi-fi of this hospital I actually received a very surprising e-mail from my sister. She told me “It was a Good timing to ask me for a good article about the dendritic vaccine as in fact I just heard it on BBC radio this morning ”
https://www.theguardian.com/society/2018/may/29/brain-cancer-vaccine-could-extend-lives-patients-years-dcvax-tessa-jowell?CMP=Share_iOSApp_Other
As I listened to Serena’s UK English computer voice reading me that e-mail, I felt overwhelmed by the positive sentence structure that they had typed out. Her voice is flat as hell but that information truly made me raise my closed hand up in the sky, like when your little football team is scoring against the posh one. Now that I have a wi-fi I can tell you that I feel the romantic mood of the Smiths, and the MTV unplugged concert of Nirvana. They just cheer me up, as “I need an easy friend”. It does seem that 7 years ago with the aid of my cool family I might have really caught a strange new way of looking at cancer which might soon become a main stream miracle.
And so, I then asked Serena to read me the beginning of page 159 of the Finch in My Brain -to remind me what I thought about it the first time around- 7 years ago.
I had written this exactly in the place where I am now hanging out and waiting for an operation once again. And yes, similarly to that very moment in this hospital this time around there are also two older men in my room and a third one who we just ignore as only the big machine next to him can remind us that he is still alive.
Here it is:
“There is one experiment that I find particularly interesting, because the researchers are going to use parts of the cancer that currently lives in my head to create a dendritic vaccine. The way I understand it is that the cancerous pieces of my own brain will be transformed in a lab, and then get re-injected into my body, where they will be recognized as normal Aliens who just went out for a vacation. They will recognize and then attack the Alien cancerous cells from within, when they least expect it. I am excited about this, as it sounds like proper sci-fi stuff, and if it works, it will be the beginning of a new way of confronting cancer.”
23RD ANNUAL MEETING and EDUCATION DAY OF THE SOCIETY FOR NEURO-ONCOLOGY
November 15-18, 2018 Marriott Hotel New Orleans, Louisiana
MAIN MEETING SATURDAY, NOVEMBER 17
10:20 - 10:50am
Abhijit Guha Award Introduction
Abhijit Guha Lecture Award Recipient: Linda Liau
https://www.soc-neuro-onc.org/UploadedFiles/2018%20SNO%20Preliminary%20Program.pdf
SNO AWARDS
ABHIJIT GUHA AWARD AND LECTURE
Jointly sponsored by the Section on Tumors of the AANS/CNS and the Society for Neuro-Oncology and presented at their respective annual meeting on alternate years, the Guha Award will recognize an accomplished investigator who has achieved significant results both in the laboratory and the clinic. In addition, the recipient will have played an active role in the mentorship of the next generation of neuro-oncology professionals.
2017 Frederick Lang
2016 Michael Taylor
2015 John Sampson
2014 Kenneth Aldape
2013 Henry Brem
2012 James Rutka
https://www.soc-neuro-onc.org/SNO/About_SNO/SNO_Awards/SNO/About_SNO/@/SNO/News/All_News
Flipper44,
Enrollment curve:
June 1, 2012: 38 patients enrolled.
June 1, 2012: 52 patients had surgery. (Sept. 1, 2012: 52 patients enrolled - 3 months)
Exwannabe,
I think that de most important thing is that the FDA requires cell therapy developers to demonstrate that no manufacturing changes affect their product profiles for safety, identity, purity, or potency.
Article:
Factories of the Future Can Patient-Specific Cell Therapies Get There from Here?
Brian Hampson and Jacob Ceccarelli.
Note:patient-specific cell therapies (PSCTs)
CoMparabiliTy risk
When exploring the four drivers of commercial viability — quality, cost, scalability, and sustainability — a PSCT developer must consider the potential comparability risk and anticipate the implications of making changes after or during late-phase clinical trials to address them. As dictated by the US Food and Drug Administration (FDA), cell therapy developers must demonstrate that manufacturing changes do not affect safety, identity, purity, or potency. Depending on the nature of the change and product characterization results, a demonstration of comparability between pre- and postchange product might require only laboratory testing or could require additional clinical studies. Early in a clinical development program, a manufacturing process change does present comparability risk. But much less is at stake at that point than after substantial clinical data have been generated, when establishing comparability would be costly for the developer or even could require repeating a late-phase trial. Some process changes have relatively low comparability risk, whereas others have relatively high risk. For example, changing a critical raw material in a core process step (e.g., transitioning from animal serum to serum-free culture media) would present a major comparability risk. However, the risk associated with switching from manual recordkeeping methods to electronic record-keeping would be minimal. Risks generally are lower when changes do not alter the journey that cells take (Table 2).
Doc Logic,
Remember that cell selection through closed system and MULTIPLICATION after selection both contribute to safety. The multiplication process reduces need for extra leuk procedures. I don't know if this was allowed because the screening process did take out patients that could not provide enough precursor material but that may have only been from earlier in the trial. NWBO does have this ability though and they also know that certain cell type characteristics are critical to successful treatment. They have news! Best wishes.
I think Mark Lowdell, Professor of Cell & Tissue Therapy University College London, has interesting comments about the optimization of the manufacturing process during the clinical trial in the next video (Dec.2015).
An interview on Cell Therapies with Dr Mark Lowdell, UCL, RFH.
Ahead of the Cell Therapy Manufacturing & Gene Therapy Congress 2015 in Brussels, we sat down with Dr Mark Lowdell, Director of Cellular Therapy & Biobanking at Royal Free London NHS Foundation Trust to talk about the state of the cell therapy industry.
Sentiment,
I wish your husband a speedy recovery to full health!
Thanks for all your hard work Senti! My best wishes to you and your family!
Doc Logic,
I give you another “Code” (lol)
Mike Hogg is a guy who, in the past, asked a lot of questions about NWBO but never got an answer from Mitch. Until today, Thursday, September 13. (coincidence?)
Read this:
Brian Babcock
11 Jun 2018 at 3:54 pm
To quote you, Mitchell:
“a key part of this was being open and transparent in our communications with our investors, regularly engaging with them so they can understand how the funds’ portfolios are constructed and managed”
Yet you refuse to say anything in reply to any comment on NWBO for years. Seems as though you guys are in a pickle of some sort.
Mike Hogg
13 Jun 2018 at 4:47 pm
Maybe Mitch is out birdwatching, at least the swift’s in my town are breeding this year after a failure last year. NWBO update please.
https://woodfordfunds.com/words/insights/roundup-may-2018/
Mitchell Fraser-Jones 13 Sep 2018 at 4:08 pm
Hi Mike,
I’m afraid we do not reveal whether or not we are insiders on any position,
for reasons of market sensitivity.
I hope the swifts did well in your area this year – they seemed to be in good number by the end of summer in my neck of the woods.
Kind regards
Mitch
That was an answer to this question:
Mike Hogg 06 Sep 2018 at 11:21 am
Mitch, thanks for the updates some positive news on PCT and hoping it may head back to its launch price before to long. I know you don’t like talking NWBO but is there any reason why cannot trade, quite simply could you buy or sell shares in the company today for example?
https://woodfordfunds.com/words/insights/roundup-august-2018/
I was thinking the same. Thanks!
Woodford Funds
INSIGHTS
August roundup
Mitchell Fraser-Jones 4 September 2018
https://woodfordfunds.com/words/insights/roundup-august-2018/
Mike Hogg
06 Sep 2018 at 11:21 am
Mitch, thanks for the updates some positive news on PCT and hoping it may head back to its launch price before to long. I know you don’t like talking NWBO but is there any reason why cannot trade, quite simply could you buy or sell shares in the company today for example?
Log in to Reply
Mitchell Fraser-Jones
13 Sep 2018 at 4:08 pm
Hi Mike,
I’m afraid we do not reveal whether or not we are insiders on any position, for reasons of market sensitivity.
I hope the swifts did well in your area this year – they seemed to be in good number by the end of summer in my neck of the woods.
Kind regards
Mitch
Flipper44,
Tomorrow we enter week fourteen on the NICE timeline.
Flipper44,
It seems like the Fraunhofer production process is(was) not 100% identical to the American.
The therapeutic agent already has been and is being successfully used in clinical trials in the USA. As part of the project, the existing GMP manufacturing process, including quality controls, was transferred to Leipzig by the American manufacturing company Cognate BioServices Inc., where it was also adapted to the European legal foundations which are stricter in some respects.
Correction:
median OS and not medium OS is 16.9 months. (oeps my fault)
Flipper44,
For the unknown group (n=38), medium OS is 16.9 months based upon Senti’s charts.
Step down 97 on the OS curve. At 16.9 months a difference of 19 events with the combined meth(21 step downs)/unmethylated(57 step downs) curves and 1 LTFU unknown (9 1/2 month).
Only 1 patient from unknown group beyond 36 months. (alive or evented at the time of the analysis.)
43/144= 30%
Well, i can not believe the investigators missed it!
Flipper44,
Sentiment calculations unknown group = 38 patients.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=143494284
1 patient alive from unknown group prior to 36 months.
1 unknown LTFU.
35 OS events unknown prior to 36 months.
Conclusion:
38 -1 – 1 – 35 = 1 patient from unknown group beyond 36 months. (alive or evented at the time of the analysis.)
So we should see something on NICE in a couple weeks, or are we still waiting for future dates? Just curious when new public info may come out with respect to NICE.
Sentiment,
It is not that important but step down 197 is missing on the OS curve.
So, you have 207 dead patients between month 0 and month 36.
Sentiment,
I did the count a few weeks ago and I had the same problem to see it clearly enough on the OS curve but it was clearer when I looked at the methylated and unmethylated curve.
For me, censor 10 on the methylated curve and censor 13 on the unmethylated curve have the same dimensions as all other double censors on the various curves. I believe you can add two more censors.
NOTE: I checked the 2 censors in a different way as you Sentiment ! Censor 13 on the unmethylated curve is a thick black line and for me a double!
Sentiment,
Another remark (sorry):
I think censor 10 on the methylated curve is a double.
The vertical line 10 has the same dimensions as line (censor)15-16! (on the methylated curve) IMO
Sentiment,
Great job, thank you!! Maybe one error : 26-27-28 on the unmethylated curve and only 55-56 on the OS curve(I think).
Journal of Translational Medicine
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6%20/
Among the ITT patients with a surgery date?≥?30 months prior to the data collection (n = 223), 30% (n = 67) have lived?≥?30 months, and their KM-derived mOS estimate is 46.5 months.
Sentiment,
I have a question.
Did just 67 live past 30 months? Or were 67 alive over 30 month at the time the data was taken for the journal?
And if 67 were alive at the time of the analysis why don’t we see 23 censors between month 30 and month 36? (67 – 44 = 23)
Journal of Translational Medicine
Among the ITT patients with a surgery date ≥ 36 months prior to the data collection (n = 182), 24.2% (n = 44) have lived ≥ 36 months and their KM-derived mOS estimate is 88.2 months.
Gerno Schmiedeknecht
Head of Main Department GMP Cell and Gene Therapy at Fraunhofer Institute for Cell Therapy and Immunology IZI
"Fraunhofer IZI's Main Department GMP Cell and Gene therapy is proud that we have supported the European arm of this complex clinical trial by manufacturing and supplying the investigational medicinal DCVax-L products to the clinical trial centers in UK and Germany."
https://www.linkedin.com/in/gerno-schmiedeknecht-9a289850/detail/recent-activity/
Flipper44,
Remember Sarah Rigby at the ASCO 2018 Presentation for DCVax-L - Sunday, June 3, 2018
Quote: Hello. My name is Sarah Rigby, and I live in Hong Kong, and I’m six and a half years now past diagnosis………
I still take the vaccine every six months!
Sarah Rigby - minute 31:55
Hello. My name is Sarah Rigby, and I live in Hong Kong, and I’m six and a half years now past diagnosis.
So a part of history of my story is I was forty-six when I was first diagnosed. It was devastating, actually, and as a mother of two boys who were twelve and thirteen, it… I found myself worrying more about them than I was worrying about myself, per say. Because I was thinking, you know, I’m not done, yet, you know. I don’t have time for this diagnosis. I’ve got to keep going. And yet the doctors were saying to me, well, six to, and the most optimistic ones were saying eighteen months. But it didn’t sound much to me, and it didn’t sound long enough. And I think, similar to Jason, I had a group of friends and family who were prepared to get busy and look for options. The doctors didn’t, at my hospital didn’t seem to have any other options other than the standard treatment. But we came across DCVax and that was the beginning of my relationship with the company. And in that time, I’ve had an MRI every six months.
I am symptom-less. I have no sign of active disease in my brain.
But really, I guess from my perspective, and something I’d really just want to say to you is what it feels like to go from thinking that it’s all over, and it’s all over quickly, before you have a chance to finish bringing up your children. What it feels like to suddenly have that extra bit of time to know that you can carry on being a mother to your children. And these days, my boys… they’ve both left home. They both finished school. They both did well into their exams. And funnily enough, they’re both studying to be doctors. So they’re in the UK, and I say to them sometimes, you know, boys, I hope you’re not being doctors to cure me. I’m, you know, doing fine. I hope you’re not curing cancer. And they say, no, no, no, mom. But you know, they’ve done extraordinarily well. And you know, maybe I’m sort of over egging it if I think maybe that’s due to the fact that I was there to finish off them growing up. But I not only survived that time that I never thought I would have, I survived in a way where I was healthy. I felt good. I looked good. Life was good. I could go back to living the life that I was living before I was diagnosed. And that’s powerful. That’s really powerful. That’s quite something. I never had to think about I was a cancer patient. I was a wife. I was their mother. I went back to work. And I’m very aware that I’m in nice contact with a bit of wood here, so I’ll stroke it a lot, and say long may it continue for me. I still take the vaccine every six months. And I would just like to echo as well what Jason says is that I talk passionately about this smart technology that allowed me and my family to carry on since my diagnosis. And I just want other patients to have had the positive experience that I have had. Thank you.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=142168678
Sentiment,
Those 2 LTFU patients between 23.1 months and 36 months is a guess. I count 67 censors between 18 months and 36 months but i could be wrong!
I am sure of the other 11 LTFU patients!
IMO
Sentiment,
I found the 11 LTFU patients (0 month and 18 month) on the first Overall Survival curve.
I guess there are 2 additional LTFU patients between 23.1 month and 36 month.
After reviewing the ASCO 2018 video (Marnix Bosch), I found 3 additional step downs beyond 36 months. Video 19m,22s. Look at the end of the methylated curve between month 36 and month 37 ½.
207 step downs prior to 36 months and 3 step downs beyond 36 months as of March 2017.
So, 210 (207 + 3) died.
13 (11 + 2) LTFU.
108 (67 prior to 36 months and 41 beyond 36 months) Alive.
Total: 210 + 13 + 108 = 331
IMO
https://www.nwbio.com/dcvax-personalized-dendritic-cell-vaccines/
Great job Sentiment!
One comment: i believe you have to put LTFU patients into your recent calculations.
Your calculations of the step downs match my calculations from a month ago!
207 step downs prior to 36 months and 3 step downs beyond 36 months as of March 2017.
See post 185680 Thursday 08/09/18
Note:one typo in my previous post. Not 115 patients but 155 patients died between 0 and 23.1 months
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=142808203
Lykiri
Thursday, 08/09/18 04:46:22 PM
Re: sentiment_stocks post# 185676
Sentiment,
mOS is at 23.1 month. That is event 166 (ITT 331/2)
11 LTFU between 0 an 23.1 months
166-11= 155 step downs (115 patients died between 0 and 23.1 month)
Note: i count exactly 155 step downs. (on my way)
10 step downs between 23.1 and 24 months. ( 10 patients died)
26 step downs between 24 and 30 months (26 died)
16 step downs between 30 and 36 months. (16 died)
3 steps downs beyond 36 months. (3 died= my guess)
I guess 2 LTFU between 23.1 and 30 months
Conclusion:
155+10+26+16+3= 210 died. (at the time of the analysis)
11 + 2 =13 LTFU (at the time of the analysis)
210(died) + 13(LTFU) = 223 events at the time of the analysis.
108 patients alive at the time of the analysis.
223(died) + 108(alive)= 331 ITT
Note:exactly 44 patients lived at least 36 months at the time of the analysis! (see scientific publication)
IMO