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I don't follow this board as frequently as I once did but wanted to personally thank many of you for your support and help throughout our 3 1/2 year journey. Laurie was fortunate in many regards to have access to some of the latest and most cutting edge technologies, but unfortunately her cancer was far too elusive to overcome any of the chemo/immunotherapy/radiation, etc. that we tried. We were able to try Direct, Ipi, Opdivo and Iclusig (this had some positive effects that hopefully they will learn more about why...) and she fought to the end for her kids. Amazing woman, amazing wife and amazing mother. The world lost a very bright light and someone that spent more time uplifting people and seeing the good in them, then trying to find ways to hurt others. Hope I can learn from her example.
God Bless everyone,
Ben
Beartrap -
Can you clarify the statement below as I'm slightly confused by a couple points you made below.
1.) Dr. Subbiah (as well as others at MD Anderson) were very familiar with how immunotherapy works and remind patients that growth is not necessarily indicative of disease progression. I imagine all patients that went through the trial received the same information. Maybe they got differing opinions from their home oncologists after they re-checked back in with them between injections.
2.) Are you saying that Dr. Bosch told you that patients in the Direct trial have not gone on to subsequent treatments after they finished their Direct injections (or after they stopped taking any Direct injections?)
I would think Dr. Bosch speaking to whether additional treatments AFTER Direct have had any effect would not be something he could ever know for certain.
"No Patients received other care through Sept?" I know that isn't true for us, so that's why I'm probably confused with what you are talking about here.
Exwannabe - Although you took my quote out of context, for your own obvious reasons...the issue is not Northwest.
The issue is that ALL companies suck at updating that site and as someone who is on there every day searching for new trials, etc., it is a huge disappointment that companies worth billions are just as egregious at updating than ones that are worth far less. Whatever the checks and balances are for updating this information it is obviously not working.
Thank you!
Despite all the back and forth on here lately, just wanted to publicly thank a number of you who have continued to provide support and information when I very desperately needed it. It was incredibly helpful and you know who you are. Truly some incredibly compassionate people here.
Second, I've been saying this for a long time but CLINICALTRIALS.GOV is a WASTELAND of misinformation, just plain wrong information and inaccurate dates/contact information/study status', etc... This spans ALL companies. We've had issues getting correct information from Pfizer, Merck, Genetech, and Northwest is no different. If you are looking at Clinical Trials.gov for any information to support whatever theory you have, forget about it. I would consider it one of the most unreliable resources available. We even had one trial that was recruiting 3 months before it even showed up there... I don't know what the protocol is for updating that registry and who oversees it, but it honestly sucks sometimes. It also drives me crazy when sites don't have contact information but you are directed to a hotline creating even more steps in the process. Alright...done complaining.
I would recommend molecularmatch.com. This is a much more user friendly experience for doctors and patients alike and has a much more sophisticated search tool. But even here, there are mistakes.
Best wishes to all of you.
I would be immediately skeptical of a cancer support message board that is riddled with comments regarding investment advice as well as links to Yahoo Finance lawsuits. That is not the place for such conversations.
I would be just as skeptical of patients posting on investment boards guaranteeing the trial(s) success/failures based on small anecdotal evidence. Neither is a guarantee despite anyone commenting to the contrary.
I will say this though...I would hope that all patients in the trial were made aware of what the halt was for and why if it was a safety issue. That would be the ethical thing to do as they all shouldn't have found out by reading it online.
When we were involved in the Direct trial, we were made aware of a hold on the trial due to a protocol change that lasted about 3-4 weeks as the IRB scheduled meeting took longer than expected by the trial site.
I have no clue what the temporary halt is for and pray for patients sake that this trial can finish as planned and determine with statistical significance whether or not it can be a new and viable treatment for cancer patients.
Best of luck everyone
I think it would be great to find patients that are in these trials that you can help support. Even if the trials themselves are free, some patients travel great distances and their families also suffer financially due to their loss of work, etc.
Who was the lady who was entering the DCVax-L trial who lived in Canada? I can't seem to track down her page where she was raising money for travel expenses. She would be someone that could benefit.
Keep up the great work.
So you are here to make the world a better place? Not to make money?
JML doesn't know the dosing schedule.
Pyrr doesn't know when the protocol was changed.
They have made guesses and then taken that information and drawn their own conclusions from those guesses. According to Pyrr the L trial was already stopped for efficacy.
They also didn't spend hundreds of hours at MD Anderson in this trial. My experience is not second hand.
Michonne - Have you visited any cancer message boards to share these grave concerns and warn patients?
The scare tactics are a bit over the top and I've already debunked much of what JML has written (which was also in agreement with Pyrr). Data is a funny thing. You do really only see what you want to see (positive and negative). Your strategy is to look at the data and take the worst possible assumptions and conclusions in an effort to make money. Please don't pretend you have any other motives to warn cancer patients about fraud. I have a number of people that I have tracked down who have participated in the L and Direct trial and none of them would agree with any of your assessments.
In fact, many are hoping to continue on Direct if they offer a compassionate use option coinciding with their Phase 2. Why would that be?
There is no doubt that this treatment has benefited a number of individuals, and it's up to the trials to finish in order to gain a better of understanding of why that is and what characteristics patients had that may or may not have responded well to treatment to inform and enhance research and development.
This is not a sham and you trying to convince people otherwise is really appalling.
Sadly iclight you only see things in the most negative light possible and really don't understand how all of this works. I'm probably not going to change that view. JML doesn't even understand the injection schedule, the method A vs. method B time frame, nor the trials' protocol so its impossible to debate.
Patients receive a leukapheresis when they are enrolled. Some patients even have to repeat the procedure if they don't get enough for at least 2-3 injections.
At the conclusion, it is more than likely that not all patients would have 6 injections created from this process. I would say 4 or 5 injections is more likely. I would also guess that all patients that received 6 injections were on the 2M dosage. 6m and 15m would be much harder to get 6 from.
When an injected tumor is dead, there are a number of possible scenarios that are played out. However, if the average patient has 3 tumors, you have quite a few that only have one. What do you think happens when a tumor is injected for a 3rd or 4th time and the biopsy report states the tumor is dead? And by the 3rd or 4th time, they have 3 other "baseline" biopsies to compare information from.
Best wishes.
Flipper -
One thing that you forgot to include, and something that those not part of the trial (or the DCVax-L trial) would be aware of.
Not all patients in this trial or L trial will be able to produce enough through the Leukapharesis process to get 6 (6+ in L trial) vaccine shots created.
The number of vaccine shots are not necessarily an indication of success/failure, but an indication really of the patient's ability to produce that number.
This data being presented by Northwest could be whether the shots a patient can produce/receive could also be an indicator of the success of participant and further establish baseline criteria for the Phase II.
Best wishes.
Glad someone finally pointed this out. Thanks Flipper.
Koman - I don't have a lot of time to reply to every post (but I try and keep up with the conversations), but I'll try and answer this and expound on my motivations.
Have you had a family member that has dealt with cancer. The standard for all cancer patients whether in trials or not is about every 3-4 months they are scanned. In trials, sometimes that is moved up to 2 months. Week 0, 8, 16, 24, 32. We have also had experiences where they have scanned us in < 2 month intervals to really get a sense of how the tumor is responding to treatment. There is a set timetable based on protocol, but that can adjust based on circumstances. My guess is many patients in this trial are getting MORE scans so that they can really see how a dead tumor changes over time. Also, in trials, the hospital gives you a general read out of the biopsy result and the scan result. You can probe further for details and that's what we did.
In all, MD Anderson has , ~3-4 scans, 7 different biopsies (4 injections X 4 biopsies of injected tumor) and a 5th biopsy later along with 2 others to a liver metastasis and lung metastasis. 3 of those 5 of the injected tumor were confirmed to have no live tumor cells, and Dr. Subbiah said it was dead.
I hope this helps.
Here's my motivation: When I was researching about this trial/company on Google, the second or third site that popped up was a thread on this message board. So I guess it bothers me some when I know that there will be eyes reading this board that are really searching on behalf of a loved one despite it being an investment board and they are provided with misinformation (both good and bad). Fortunately at that time Adam Fuerstein's articles were not that high on the list.
If I end up being wrong, I will have to live with the fact that I have wrongly persuaded some people to enter this trial (though with limited toxicity and quick dosing regimen for Phase II it would be for a couple months before God willing they could move on to a new trial). I have stated many times that this trial may not be a good fit for everyone depending on a limitless number of variables. But if I came on here and lied and tried to manipulate people in an effort to put this company out of business to make a quick buck, I think you have the potential to negatively effect millions of lives. So I respond when I know people are spreading lies (or passing off opinions as facts).
I would prefer Northwest has the resources to complete their trials. This really hit me when I sat in our oncologist office recently and he talked about a drug that he has been trying and trying to get to his hospital but the company didn't have the money to expand beyond two trial sites despite some great efficacy data for certain mutations of cancer. He was really upset that his hospital wasn't chosen to run the trial. So patients in his area would not have the opportunity to try this treatment. This is the lens in which I view the world.
I'm also not naive and realize there are companies out there that are scams and are not looking out for the best interest of patients nor their shareholders. I can tell you from my experience that I don't feel this is the case here. But we are but one patient and one example.
Best wishes
Moneyfrog - If Sentiment wants to PM you my email address, that's fine. I don't have that capability.
Every person is different and I could never say with 100% confidence that Direct would be the best option for your situation. It depends on a lot of things, especially what cancer you have, the specific mutations (if you got the tumor or biopsy samples analyzed through genomic sequencing) and what available therapy is currently approved to treat it and the risk/benefits of that therapy. It also takes a lot of conversations with your oncologist to decide if going this route makes sense and is "reasonable." Our oncologist was very supportive throughout and was very eager to hear back on our experience.
For example, if you were dealing with Melanoma, I would certainly push to see whether Keytruda was an option before going the Direct route, but again that's a decision for you and your doctor.
Prayers to you and your family.
orwhat - this is just my own experience. Again, others probably have their own unique path and direction in the trial depending on their response, their ability to research and be proactive and being a good advocate for themselves, etc...
Cancer is no longer being recognized as associated with a body part. It's being associated with a genetic mutation, regardless of location HER-2, BAP, FGFR, etc.... Many treatments in effect work to some extent in a patient population due to striking gold and maybe hitting that specific target. Foundation One is the company on the cutting edge. Anyone have a tumor biopsied or resected needs to have it shipped there!
I think oncologists will agree that cancer is a moving target and is not something that can be easily attacked with one weapon, and one weapon that doesn't adjust. Pharmaceutical companies don't like to hear this because making one pill is cost effective and makes them a boat load of money.
I would recommend highly that any cancer patient enroll in this trial (especially if they have exhausted SOC) and the Phase II protocol will hopefully do a better job IMO of picking up multiple mutations from the tumor and training the immune system even better. But NOTHING is guaranteed. I just think it's very much worth the shot and on behalf of my family I thank you all for investing in this company and giving us an opportunity to take part in this trial.
I'm not a scientist and I don't play one on tv. I've just spent too many hours in doctors offices listening to the frustration of oncologists on the current state of affairs for many cancer patients AND the limited resources that many small companies have to expand their trials despite their potential (and despite doctors willingness to try and bring these drugs to their hospitals).
And with that I've been so incredibly sickened by those that take to these message boards and lay out scenarios that are entirely fictitious in their own minds, yet pass them off as truth and facts. As George Constanza famously said "it's not a lie, if you believe it." He also ran down the women and children on his way out of the burning building.
Best wishes
A word of advice.
I do read many of the comments over at Investor Village and this guy jmlogan is a real piece of work. Apparently he has the extreme confidence in his theories despite most of them being based on fantasy. Being part of this trial, I would never even attempt to present any of those facts with that kind of confidence.
Here is a bit of facts.
1.) All patients (after the protocol change in February/March 2014) have a biopsy of their tumors. Many patients that started at this time will have 3-6 biopsies. We were fortunate to be granted the request of biopsying distant tumors as well which provided Northwest with a much broader scope of how effective/ineffective treatment could be on distant sites.
2.) AT 8 weeks, patients are rescanned. At this visit, the day before getting your injection you consult with the doctors and they make a determination as to whether they feel the treatment is having any effect or not. We had progression but knew from biopsy's (and from comments from the doctors at MD Anderson) that we should try for the 4th injection due to the tcell infiltration that was exhibited, the extensive tumor necrosis that was going on (all despite the scans showing progression).
3.) Despite progression, we still went ahead and had a biopsy before the 4th injection.
4.) Upon returning for Week 16, things got a little more tricky as there was still progression, despite the injected tumor being dead. We then requested 3 biopsies (one again of injected tumor and 2 distant sites...one in liver and one in lung). It was confirmed for the 3rd time that the injected tumor had no live tumor cells, another liver tumor not injected had good tcell infiltration and a distant lung tumor also had some tcell infiltration.
I am frustrated with the wave of individuals that display such arrogance and confidence that the treatment is having no effect and actually presenting their information as solid fact, when it is very far from the truth. We (not a collective we) are learning very quickly in immunotherapy that FAST action is not always GOOD action.
Each individual in this trial I am sure has their own road they are traveling and we have been extremely impressed with the care that we received and the concern that not only the doctors have had, but also our dealings with people at Northwest and the MD Anderson doctors. I can assure you that MD Anderson and Northwest's relationship is very good and very collaborative.
I really hope and pray this treatment has amazing results and I see no reason to try and put this company out of business. Our experience was great and we have no regrets. I am frustrated by the delay in the release of results but mostly because I'm an impatient person. I would love to see these trials (L and Direct) finish and have the resources they need to do so.
I appreciate so much the information that many of you provide but be weary of many of these people that speak and model with such confidence but have no idea what actually goes on in a trial. I saw someone posting about a patient only 15 or 16 months out from treatment and comparing that this patient should have an mOS of 36 months. Problem with that comparison is that 36 month clock could have started 2-3 years ago when they first were diagnosed at Stage IV and began chemo or SOC treatment. Patients in the Direct trial initially could have failed UP TO four previous treatments. The new protocol has NO limits. So in essence, patients could have failed treatment for a couple years and five or six treatments and then are enrolling.
Anyways, Flipper, if you are reading please shoot me an email if you remember it...I had a question for you.
Best Regards
Maybe I'll have time to address other issues at a later time.
I’m only coming back to interject some facts in to this discussion and I’m not really up for debating points with people that are so embedded in their positive and negative thinking really only here to try and prove to be right and the other side to be wrong.
METHOD A and METHOD B –
There are only 2 possibilities in my mind of when the company decided to move ahead with this. Based on their patent design and multiple ways to manufacture and mature dendritic cells, I would guess that this was all part of the original trial design.
However, if you are skeptical…if the company decided to change the treatment (and the vaccine) that was going to be given to their patients midstream, they would have to have the trial stopped and the IRB would have to interject to incorporate such a substantial change. They are giving essentially a completely different vaccine to patients. The only time this occurred was in February and March of 2014. How do I know? Because we had been enrolled and suddenly the trial was put on hold as the protocol was changed. Along with this protocol change came the mandatory biopsy that would accompany each injection. This means that at the least, patients 9-40 all were getting a random assigned method of maturation. You'll also notice on that chart that as soon as the hold was lifted, you have at least 5-6 patients all starting the trial and are now at 14 months.
Based on the chart as well, as others have pointed out, Method B would HAVE happened at the very latest in April, 2014 as patients 8-12 all started treatment then. So simultaneously all 4 of these patients would have been receiving vaccines and at least 3 of them could have had Method B at that point. So yes, Cognate can in fact manufacture both Method B and Method A at the exact same time.
Afford - it simply means I'm not qualified in any way to assess the validity of those concerns.
Flipper - The short answer is that in all of our dealings with the doctors at MDA, they seem so involved in the work that they are doing, etc. that I don't get the impression they follow much of this AF nonsense. They make decisions based on what they think is best for their patients.
For the benefit of my own stress level, I'll leave it at that. The fact that he felt it necessary to reach out to a clinical trial site and try and create a mystical rift speaks to the kind of human being he is. His actions could have put the entire trial (including enrollment, etc.) at risk. I wonder if he's done this with other hospitals/trial sites? why and why not?
With that said, his concerns on the business side of Northwest could very well be valid. However, the fact that he's gone to great lengths to lie and deceive when it comes to the science and to the trial makes you have to question everything he writes as his motivation is to try and drive this company out of business. He may honestly feel in his mind that the company is a scam and something he picked up on at a presentation has stuck with him and molded his opinion so he has this basic assumption that they will fail. He then writes his articles posturing his opinions as facts that he confidently states feeling that months down the line he will be proven right.
I'm having a tough time finding anything in his last 2-3 years of writing on this company that has turned out to be true.
Since Xena deleted my other post, here is the condensed version:
Titimi - I know others have reached out and given you contact information. My advice is to continue reaching out to all avenues:
---Fill out patient queries on Northwest's website.
--- Contact ALL clinical investigators at both sites (call and email). they are VERY busy people so don't be frustrated without an immediate response, but also don't wait to hear back...keep calling and writing.
Feel free to email me at hodge14@hotmail.com as I have additional contact information of doctors/liasons that could be of further assistance but they are not publiclly displayed so I don't want to release them here.
Stay focused and don't stop contacting people. They receive probably hundreds of inquiries a week along with actually having to see patients, so you want to make sure your message stands out and that you are persistent (in a nice way).
Best wishes and my prayers are with you and your family!
I understand your viewpoint TOB as the purpose of your post was to come to the defense of AF's questioning of the PR following the financing deal (7 days prior) that he tweeted out.
However, as I stated before, this same person has criticized Northwest regardless of this 2 week before/after rule, so it really has no credibility in this debate. Even if the questioning was legitimate in this case, it isn't credible due to his inability to consistently apply this "unspoken" rule.
Motives become increasingly obvious when you can't apply these "rules" consistently.
Apparently these rules are arbitrary.
On March 10th, Northwest announces H.E.
On April 10th, they announce a 32 million financing (1 month later).
But yet the same criticisms were levied.
Again, it's such an incredibly weak argument and for a company of this size that has to PR it's major and minor accomplishments, I would say its close to impossible to fit in to that tiny window of yours (2 weeks before and after).
TOB - I respect your opinion but still think its absolute nonsense to play both sides of the argument.
Over the past year, Northwest averages 2+ PR's per month. Playing the odds, financing would precede and proceed each and every one of these announcements and I don't need a financial blogger to point this out to me.
TOB - Can't play it both ways...
The normal critique of Northwest is that they PR, and then a week or two later announce financing.
Now he wants to play the other side...Finance, and then good news.
Which is it?
In other words, when can a company announce financing...before, during or after a PR?
I'm confused...but I guess that is what his motive is.
In follows the playbook of "where are the results?"...oh wait, you released results..."exploitation of results..." "meaningless data."
It's old and tiresome.
As an aside...
It took 5 months to finally get our insurance to cover the DCVax clinical trial in Texas...and this required a lot of paperwork, signed documents from primary care, oncologist in Boston, etc...
It is a tiresome process having to be on the phone with customer service almost on a daily basis. The letters, records, etc... all while having medical bills hanging over your head is just incredibly stressful and frustrating.
I'm hoping this HE process in Germany eliminates all of these hurdles for patients. If it took me 5 months as one individual, I can't imagine the work going on behind the scenes to get this done.
Steppen -
I could of worded that statement better, not that we will still agree. My view is that Northwest is operating in the blind with many of these endeavors (PIM, Hospital Exemption). There are certainly guidelines that these processes follow, but many of them are still in flux (PIM in particular) and the process is not yet finalized.
Northwest, in a lot of ways, is limited in what they can say as a realistic expectation because we don't have other companies to look to for guidance of how long the process should take. If at the end of 12 months, negotiations are finalized, the next company that lines up for this will have a good idea what they are working towards. Weren't the other companies that received H.E. grandfathered and they may not have had to deal with the extent of negotiations that Northwest is going through.
So in that regard, I don't feel they have the ability to see in to the crystal ball and know exactly when negotiations will finalize. Nor should they be responsible for watching a message board and squashing every rumor that is presented here. They have done enough of that with AF...and honestly they should have provided a link to his March 11th article and stated : "so you still want to take this guys advice?"
Could I start the rumor now that Germany has fully accepted the changes to the trial protocol and this is why patients can now be treated? It would all be speculation but I fully expect that this will be the majority opinion.
In the end, I think we all agree that patients deserve this treatment as quickly as possible and today's news is a step in the right direction. If you were expecting 100 million in revenue this week, you will obviously be disappointed.
Austin - Here in lies the problem with message boards and the difficulty I personally have in reading them.
Much of the "unrealistic expectations" placed upon this company is found right here. Much like the fear mongering that AF trumpets, I read some of the posts here and scratch my head that they are just too unrealistic for any company (never mind a small biotech) to accomplish overnight. We all want these results yesterday!
Then where it gets comical is that these unrealistic expectations become part of the "facts" spread around here, and then when things either go slower than planned, change course, or develop (such as the incredible news today), enough ridiculous scenarios have been thrown against the wall that you are disappointed.
Yes some of this is the fault of Northwest for not doing a good job of updating timelines, but I don't really put the job of tempering expectations at their feet.
This is a great day for that GBM patient, and presumably many others that a country is allowing a safe (and according to all data to date an effective treatment) to be utilized by its entire population and the insurance companies will reimburse. This is so revolutionary that the painfully slow process is obviously frustrating. But it allows me to appreciate even more the kind of bureaucracy this endeavor is having to knife through. Hopefully it will be a pioneer for other treatments to be able to have the same options available to patients in the future.
AF's prophecy on March 11, 2014:
I'm not much of an investor so I don't think you should value my opinion. But on December of 2013, Adam released an article that stated DCVax-L was going to fail.
The share price on that day was $3.63.
You would have missed out on a nice ride if you took his advice then.
I try to stick to the science behind DCVax but understand all this FUD is going to make it difficult for Northwest to continue running their trials.
Steppen -
I think the comment was "continue our progress undeterred..."
Regardless, I share in your frustration that no further Direct results have been released and I partially blame Adam for attempting to create a rift with a clinical trial site and its sponsor. This is by far the most unethical display of journalism I've ever seen. It's one thing to misrepresent the facts of the science, to criticize the business relationships/operations...but to go out of your way to contact the trial site and try and create a distrust and friction between them goes above and beyond any role he should be playing. I could go on and on about this, but to me this was so far out of bounds that he should have been reprimanded for this.
It speaks to a larger agenda as opposed to simply criticizing and dismissing the data.
Steppenwolf - AF still screams BS, even when half the PR is the doctor's comments relating to the treatment:
http://www.isoray.com/custom_type/isoray-announces-early-success-young-peruvian-girl-utilizing-cesium-131-first-stereotactic-implant-inoperable-brain-cancer/
Afford - I'm a skeptic so I question everything unless proven otherwise. I wasn't going to rely on a few tweets to confirm or deny based on the fact that he's a fairly well-known figure with no obituary nor news station picking up on his story regardless of whether he was in this trial or not. Still seems out of the ordinary (and maybe it's the family protecting his privacy wishes), but obviously it's true. I've learned that Twitter can spread false rumors like wild fire.
I think your bringing up the topic allowed others to further pursue and confirm on their own.
I'm always skeptical when Twitter is the only place you can find to support the facts.
In reality, all it takes is for one misguided sole to tweet out "RIP Robert Demeger," and then after a number of re-tweets you start getting a flood of people who start believing and posting tributes, etc. to him.
I'm not saying it's 100% true or not, but I still find it odd that a major British actor doesn't have an obituary or a major news outlet even picking up on the fact that he passed away despite all the media attention back last September of him leaving Othello and pursuing a cancer vaccine trial.
I would find it odd that a British movie star's passing would not be more publicized. I personally don't think he has passed on.
http://www.imdb.com/name/nm0218290/bio?ref_=nm_ql_1 - Lists only his birth...
Then see here with Heath Ledger:
http://www.imdb.com/name/nm0005132/
If the only validation you are getting about his passing are a couple of message boards, tweets and the like, I would question its validity. Honesty I remember hearing about the passing of Casey Kasem and my initial thought was "I thought that guy died years ago..."
On a final note, RK what an incredibly touching letter. Thanks for sharing.
You wrote on your blog interestingly enough:
Pyrr said:
With regards to Keytruda...
Flip/Pyrr - I'm going to hijack your conversation and perhaps mediate. As always, feel free to edit/rip apart or help educate me as I put this stuff together.
1.) Keytruda has only been tested in patients that have failed Ipillimubab(IPI) in the past, correct? This poses a couple of challenges in determining efficacy for Keytruda.
IPI, which was approved for melanoma in 2011 I believe, has been known to have delayed efficacy as well as delayed side effects. It is also a 12 week treatment schedule. Without knowing off hand how soon patients begin this treatment at the conclusion of their IPI treatment, it's not a giant leap that both efficacy and side effects associated with Keytruda could be collateral damage from IPI.
On a personal note, our oncologists have said that at the 8 week scan, don't expect results to be indicative of whether treatment is working or not.
2.) Assuming Keytruda is administered AFTER IPI, you also have to realize that IPI didn't shrink the tumors but still created super t-cell fighters eliminating their brakes to fight the cancer. Without these super tcells initiated by IPI, would Keytruda have been able to be as effective as a stand-alone treatment? Does removing the shields on the tumor (PD-1) allow ordinary t-cells to attack or is it working solely due to this combination? This becomes a very expensive treatment regimen if that's the case...but again this is based off my assumption that ALL patients taking Keytruda were former IPI patients. If my gut is true, I'm not so sure 150k per treatment is warranted if it is only effective as a combination treatment...
Here is my best analogy that I can come up with for how all of these will one day work together.
Imagine you are in a boxing ring facing the fight of your life, the world's toughest opponent (mind you are not a boxer and have no formal training).
The Checkpoint Inhibitor IPI turns you in to Mike Tyson, but unfortunately you have a blindfold on and can't see who or where you are punching.
DCVax-Direct takes off the blind fold and recognizes your opponent.
Keytruda ties your opponents hands behinds their back.
Best wishes all.
Pyrr -
I just want to interject on the biopsy topic for a second. You mentioned that for large tumors, a biopsy may show no live tumors even though enlargement is showing up on scans. I think your inference (correct me if I'm wrong) is stating that mathematically there is a chance that the sample could be coming from an area of the tumor that just happens to be dying.
While all this is true, what you also have to realize is that per the protocol for Phase I (although I'd be interested to see if any patients deviate and request injection of a different tumor when the injected one is dead), the same tumors are being injected/biopsied 6 times and if 3 out of 9 after 4 injections are dead, those tumors will also have 2 other biopsy reports showing whether or not that is still the case. They could have 3 separate biopsy reports indicating tumor death.
Would love Reefrad to join the conversation again as his insights in this area I find invaluable.
Flip - Not in response to this post, but in response to your SA article suggestion. I'm strongly considering it and have drafted the idea in my head many times.
RK - I almost wrote something similar a while back when they opened the Expanded Access Protocol.
Even the Promising Innovative Medicines is yet another way for patients to access this treatment as quickly as possible even if the reimbursement details are still being ironed out.
You have to ask yourself the question as to why a company is trying to make their treatment so accessible outside of clinical trials. They obviously are confident in not only the lack of side effects associated with the treatment, but also it's efficacy.
I'm sure this worries short term investors because it costs money to do this...but it also shows a lot of confidence in the treatment. Other companies refuse to offer their drugs even through compassionate use unless political winds force their hands.