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Immunotherapy results getting stronger for DCVAX-Direct. Background research literature suggests this trend will continue.
“As of the 3rd injection in week 2 of the treatments, we now have 65% of the patients (13 of 20) showing some positive effects, and as of the 4th injection in week 8 of the treatments, we now have 100% of the patients (9 of 9) showing some positive effects." -- NWBIO June 11, 2014
I think we can assume that all 5 main cancer types in the trial have had a response, and at least one "other." NWBO does not say this yet, but it seems quite logical.
Thanks Hodge! Miraculous!
If NWBO partners, I hope they select well.
I have nothing against Russia, but one concern would be a company there might already be encroaching on NWBO patents -- I'm not certain about this, and it is in the vast random facts flying around in my brain.
TEVA is extremely large and NWBO functions very well in Israel, so that may be a natural fit -- again, I'm not certain. Anyway, I think there is a match out there that could reduce many concerns for investors and NWBO. Mostly it should be a partner that can globalize this technology rapidly, make it available to the masses and yet still thrive.
RRR, I should add, the perfect match might become a global force. If trial results continue on track, that partner could quickly help NWBO acquire a wish-list of hopeful startups. Bosch and Boynton probably know every promising dendritic company out there.
I would like to see a partnership with a major Asian Pharmaceutical. It would fund our US/Europe efforts, allowing us to continue in our primary and secondary markets as an independant entity and give us what we need in the east. -- RRR
LTT said:
Food for the sharks and the shorts - flipper meat
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Can anyone locate Credit Suisse AG's complete buy/sell history on NWBO?
Another way AF actively hurts NWBO: Trial Enrollment.
For the last 6 months on Google, if you are a new patient or investor and you search the word DCVAX or DCVAX-L the first or second web news article you will come across is by AF.
Why Northwest Bio's DCVax Brain Tumor Vaccine Will Blow Up Just Like ImmunoCellular's ICT-107 A. Feuerstein December 17, 2013
"Cancer Patients Aren't Responding to Northwest Bio's DCVax-Direct" AF May 27, 2014
So it appears Dresden is "open for enrollment". -- Eval
The first German site is now starting to screen patients for purposes of enrollment, and the additional German sites will begin doing so following their scheduled initiations (patients can obtain information about trial sites by contacting the Company at patients@nwbio.com ). -- NWBIO June 10 PR
Speaking of which, I've been off the grid for a few days. Did Highwayman get a reply from LG? -- Astavakra
Just like the clinic openings, I think the first successful reimbursement negotiation will be a template for the rest -- even with the differences from site to site.
Excellent clarification and summary. I really did not think about Paraxell, and must admit I also got a sense that NWBO was impatient regarding clinic openings.
It appears the 1 new site in Dresden is included on ClinicalTrials.gov, so that must mean 10 other new trial sites just opened elsewhere (in the US? or perhaps also in UK? .... might need to do some digging). -- Evaluate
I'm kind of interested in what RedBaron thinks about all this.
He waited so long for this day. Years.
I'm certain he will want to hear that the first patient was treated, reimbursement resolution and so forth, BUT,
Red, more than anyone else, saw clinic openings in Germany as the primary bottleneck for everything else.
Well, I think NWBO's failure to educate and hold press conferences probably causes your sentiment. Nobody likes to be told about "luxury" in the same sentence as expanding the trial. Nobody likes to be told "actively considering it" and "a little bit" unless we are told clearly, what this might look like, that they do not have pfs knowledge -- even though they said this earlier and it is part and parcel of phase 3 trials.
Investors want to know why Linda could make predictions about DMC recommendation timelines 6 months ago, but now she apparently can't.
I want to know if Sitiain is correct -- that Germany will be able to enroll due to reimbursement requirements.
Nonetheless, this is good news.
1. It means Germany is manufacturing DCVAX-L for Germany and Europe (in addition to Great Britain), treating patients with DCVAX-L and paying for DCVAX-L.
2. It means the price negotiations are very near completion, because they need to pay reimbursement fees for patients starting therapy.
3. It means that the rest of Europe will then be able to calculate their reimbursement levels, using Germany's price as a keystone.
4. It means NWBO is a trailblazer that now is an expert in moving into a foreign market that has a high barrier to entry.
5. It means revenue.
6. It means the intrinsic value of this company is moving higher each day, not just due to ongoing direct information and possible L results, it has more value because of its incredible infrastructure and
ramping capabilities.
I think there was a sense at NWBO, who are on the inside looking out, that this would be a greatly anticipated happy surprise (timing wise) -- meaning great progress; but from the outside looking in, without prior investor education, the delay caused unnecessary anxiety that could have been quelled quite easily with the same press release 2 months ago minus the actual clinic opening news yet explaining the delay.
That is a very big deal Hodge.
Note: While I do not subscribe to the full enrollment theory before AA interim analysis is allowed, let's assume AVII is correct -- and assume Sitiain is also correct re: you can only get treatment if you enroll in the trial or are not accepted into the trial (in Germany).
These clinic openings could move enrollment forward very quickly, and therefore get us to full enrollment more quickly, and therefore allow AA much sooner, under AVII's theory.
You are missing something, but I can see why.
First, Doctor Gorter has been conducting therapy using this technology in Cologne. From all indications, he falls/fell under an exemption clause, much like many of our clinics do when they conduct small trials -- like the Triozzi study -- however, Gorter had a continuing -- like -- exemption.
Other than that, yes, the clinics were approved but none were opened until the end of May. That is why people like myself and even critics like…. were waiting for the first trial clinics to open. While I did not share the critic's cynicism, I shared some impatience (so did NWBO). Now we know why, once again, things take a while in Germany.
Another part that may have confused you is that Germany was already manufacturing DCVAX for people in Great Britain.
Sitiain, do you remember where you read this? (assuming you are talking about Germany/EMA)
If you qualify for the GBM trail you have to go on the trail. -- Sitiain
I'm headed out, but I think the subgroup numbers you quote may demonstrate why we should not take NWBO's pseudo progression group for granted. pspr responds well to dendritic trx.
Survey: Is the DMC analysis currently delayed/blocked due to "active consideration" by NWBO regarding trial size?
Feel free to respond with one word or many.
My Answer. I don't know.
How do you propose they did it? It was worked through with the FDA prior to restarting in 2011. An 8:5 ratio is not a variable day to day suggestion.
Basically, if that primary group shows SS, then and only then will they add the events from the pseudo progression group.
So, lets say you showed 16 months pfs in the 2011-2013 group. Then you place 33 more data points onto the curve, and in its own separate curve. Do not worry that this seems like an odd thing to do.
What may happen is pfs pops up to 22 months. Hopefully the trx. curves have similar, though not exact shapes.
This will be the official number, unless adaptive trial design finds a way to merge the next group (of 72).
Next, for application expansion to more types of patients, you place in whatever events you have from the group of 72. This will be an impressive number for pfs if NWBO gets some 30 month pfs data points from the treatment group. Remember the words of FDA Deputy Templeton, even in very small single arm trials for orphan treatments in AA pathways, if the results are (Dramatic Enough), approval will be granted.
Here is one more thing about the UCLA phase 2 trial.
It uses placebo adjuvants in one of the arms (the DCVAX-L arm w/no adjuvants) so I assume they do not want patients to know what adjuvant they are getting in any arm of the trial. However, it is an open label trial!
You may want to look that up in the trial design book -- I will also purchase the latest version.
Thus, it would appear to have some but not all the restrictions associated with a blinded trial, and yet…..
This does not have alpha spend issues, so I assume NWBO and UCLA have a good idea what the current data demonstrates.
In 2013, these numbers probably convinced them that H.E. was worth the effort -- along with their earlier phase I trials.
So, in many ways this UCLA trial built a ton of different qualities into it.
From Germany to Maryland and beyond….
I think of it this way.
If they front load the placebo group, they catch up very quick but then the statistical comparisons within the first group (aka 2011 - 2013) has almost no events in the treatment group within a reasonable time. Thus it would defeat the purpose of analyzing the cohorts separately.
If they back load the placebo group, they do not catch up and there would be very few placebo data points within a reasonable time.
As you surmise, I think I would split the difference so that catch up happens throughout the trial. This means a ratio that will get to 80 control patients by the end of the primary trial. So instead of a ratio of 160/80, you have a ratio of 127/80, which is 1.59:1 IMHO. or… about 8:5.
(Remember, the group of 72 does not have the carry over issue.)
Maybe you already discussed this, but did you take into account that the 2:1 ratio will be skewed
1. over the course of enrollment
2. on the front end of the trial or
3. on the back end of the trial?
(Due to the 33 carry-over)
Another reason why AF Pounds NWBO.
In something of a surprising move, Merck & Co. (NYSE: MRK ) announced today that it is buying Idenix Pharmaceuticals (NASDAQ: IDIX ) in a deal that comes at a whopping 238% premium compared to the company's closing price on Friday. -- M. Fool
All brain cancers and UCLA phase II trial.
One more thought. I was happily confused when the German H.E. program announced it would allow DCVAX-L to treat all brain cancers.
While the current UCLA phase II study certainly treats GBM among the 60 patients, it also treats other grade 3 and 4 brain cancers.
Phase 1 did not do this.
I think UCLA phase 2 is the missing link. To me, it proves the Germans looked at ongoing data to date, and this included the UCLA phase 2 ongoing trial, and we know this because the Germans approved DCVAX-L for treatment of all brain cancers! Thus, it is safe to assume they also reviewed the DCVAX-L phase III 1st interim data.
You know, sometimes I think we look at regulators as if they were computer programs, which reject all code as invalid except what they are programmed to accept. They're far more flexible than that. -- Pyrr
sentiment_stocks Member Level Monday, 04/07/14 12:44:16 AM
Re: None
Post # of 12749
FDA Chief calls for a New Era of Partnership with Biotech Firms at Conference
CAMBRIDGE — The head of the US agency that approves medicines Friday called for more regulatory flexibility and “a new era of partnership” with the biopharmaceutical industry in bringing new treatments to patients.
“We see this model emerging where we don’t just wait for an application to come to us,” Food and Drug Administration commissioner Margaret Hamburg told more than 300 drugmaking executives at the annual meeting of the Massachusetts Biotechnology Council trade group. “We engage with you early and work with you throughout the development process.”
Together, [new] programs can help three to five years off the research and development cycle and months off approval times for new drugs, she said.
“We are working hard to find ways to decrease the time between discovery, research, and approval,” Hamburg told her audience at the Royal Sonesta Hotel. “It matters to all of you, but it especially matters to patients.”
The sarcasm in the last point was not lost on me:) I think Germany looked at the ongoing phase II data in the current UCLA trial along with the 1st interim data in the current phase III trial. IMHO.
(I earlier missed the connection between these trials, because I previously anticipated the current UCLA phase 2 trial was using the new patented maturation technique, when in fact, it appears to be using DCVAX-L original methods -- but then adds different adjuvants in 2 of 3 arms.)
Synchronicity.
Moreover, could this current phase 2 trial be used for clinical endpoint purposes for 'our' trial in an AA trial design? In other words, could it have phase IV properties?
In any case, the UCLA/(NWBO) phase 2 trial might be more useful for the current DCVAX-L phase III trial than we previously thought. IMHO
(Additional note: The current UCLA trial did not exclude pseudo-progression patients.)
Question: Was this ongoing phase II trial data also reviewed by Germany?
If placebo is at 12 months, tx would need to show 11 months higher simply to maintain a hazard ratio balance. -- Pyrr
It is conceivable all 3 arms will work equally well, and far better than Historically Highly Reliable S.O.C. for GBM.
If so, one might see how GBM could become a chronic disease for some (cured for others). In other words, if you have enough adjuvants to reinvigorate an immune response when and if the old adjuvants are not sufficient anymore, you literally might be able to keep cancer at bay for a lifetime with enough DCVAX-L variations. Of course, one would hope that full natural immunity would kick in, and no further treatments would be necessary -- but just in case….
If you want to know what I mean about DCVAX-L as the "placebo," It's actually an experimental arm camouflaged as a placebo.
Look at the arms in the current phase 2 trial:
Cohort #1 will receive autologous tumor lysate-pulsed DC vaccination together with a placebo cream or intramuscular injection of saline.
Cohort #2 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant 0.2% resiquimod.
Cohort #3 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant poly ICLC (TLR3 agonist).
Would this then be a way to indirectly enlarge our phase III trial "a little bit."
If phase 2 of that current trial uses the original DCVAX-L (instead of new Direct maturation version), then the adjuvants are the only difference. For 'our' current phase III DCVAX-L trial, the FDA and even the DMC can review highly related ongoing trial info. So, it is possible, both groups (FDA/DMC) are awaiting the concurrent phase 2 comparison trial, where under this scenario, the phase 2 placebo (DCVAX-L) might actually indirectly add 20(?) more data points to compare -- and even the 2 other cohorts with different adjuvants, may increase/confirm the reliability of our current trial through a rule out like comparison. That phase 2 trial also has no cross-over arm.
1.
You mentioned that NWBO is a sponsor. Anyone else? -- RRR
Is this a DCVax-L study with only the Direct maturation technology added? -- RRR
Who owns the associated patents? -- RRR
Good Point.