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They do not suspect 100-200 is MTD. They said it is the dose range where they are HOPING to start seeing efficacy which itself is a loose term. I would suspect that is where they would hope to start seeing an impact on tumor biomarkers that are being monitored. As for MTD they may not hit it within the remaining Cohorts as stated at Ideas especially if they have any more AE hiccups which prevent the 100 percent increases. Dogs didn't have any worrying side effects until about 1200mg/m2 human equivalent dose to put it in perspective and that still might not be MTD.
Good stuff. Here's to true 28 day Cohorts.
Excellent post. Thanks! That is definitely good to know since there have been all those recent articles about flaws in mouse models.
I would note two important things:
1) Effective dose does not mean ideal dose. It means the earliest dose where we may see some response. Earlier statements were indicating where you might start to see significant tumor response. Those are likely to remain closer to 300 and 600.
2) You will also note that they have include a range of 100-200 and did not just say efficacy is expected at 100. That range is like saying within weeks. You should not assume it means 2 weeks as it gives considerable wiggle room as we have already found. The predictions you spoke of were for over 150mg/m2 minimum. This statement is consistent with the range given by management. Jumping on the low end of a considerable range and saying they really expect it there is a considerable stretch. More accurate to say they expect it by 200 mg/m2. Well that seems entirely consistent with what was said by others.
No disagreement. I just wanted to highlight that we have a very long post from TOB as a sticky and it is fundamentally wrong. The facts in the email have borne that out at least if you trust that management knows how to predict efficacy.
Interesting stuff. I think it was TOB who said something like we cannot predict efficacy off of the mouse model because a mouse is not a human. Then someone did a sticky of that. Could happen tomorrow it said. Looks like they are predicting efficacy at pretty darn close to the mouse model to me. Lol.
I stand corrected. How annoying. Out of curiosity what does the 3x3 refer to then? 3 patients in each Cohort yes, but 3x3 implies 9. Oh well.
I don't think they need to recruit new people at this point. Just escalate prior Cohorts. Another big reason why i think things should speed up.
Who took you off your meds, Lol. Somebody get this man back on his generic oxycodone, stat! Seriously there is both Prurisol and P21 data before the new year and if the trials speed up a bit (which is extremely possible if nobody else drops out) we could be at tumor shrinkage doses before the new year as well. Nobody likes a cheerleader but nobody likes a fake manipulative Debbie downer either. P21, Prurisol, tumor shrinkage. Fireworks to commence anytime between now and October. Even if the bond market blows up who in this stock gives a damn. The value will remain unchanged regardless.
There is not going to be a bond crash... 1.40 is not coming. Plenty of support at 1.80.
At these dosages all on par with animal studies means is that K isn't causing unforeseen toxicity.
Burger King has said they had posted materials that indicated 60mg/m2 had seen elevated P21, but who knows if he remembers that right. Those materials had been removed from the website so nobody can fact check it. Could someone please beg management to put those materials back online? They are important.
Thanks for the link. Done. But if I get nailed with spam I will hunt you down :)
One can always hope they increased Cohort 4 to 60mg/m2. Possible given no Issues were found with third cohort and third cohort dosing increase was extra conservative because of issues with the one patient in Cohort 2. However, even if they kept the conservative dosing, what difference will one more Cohort make anyway. Who says they have to stop at 10? Heck I say let them go to Cohort 12 if they need to. Will give ever more efficacy data which can only be a good thing prior to blinded trials.
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Who cares how many people were interested at ASCO. Even if nobody came by it wouldn't mean a thing. Results as always are what matters. Heads will turn when the Company really has something to say. That day is approaching quickly, but it certainly was not ASCO.
The ASCO poster and other posters on the events page of the CTIX website lay out the mechanisms of action pretty well though you will have a hard time following the various pathway diagrams without some significant outside knowledge. The molecule itself is novel. Sure there is a more scientific way to describe it, but that's what I can tell you.
Try not to forget the obvious possibility that they really didn't run the tests yet. Nothing should be assumed from the request for more samples. I am disinclined to think they would lie about the reason for the delay (specifically that the lab has not run the tests) because obviously there are people out there (the lab and DF) who know the truth and would not approve of misleading statements. As for your theory, of course they would still want to run cohort 3 even if nothing was seen on 1 and 2 because 3 is a slightly higher dose. They will also run it on the cohort 4 even if 1, 2 and 3 show nothing.
Also for the curve, remember you can make a curve from the datapoints 0, 0 and 1. But beyond that I see no reason to require a curve at all. An absolute increase from baseline would do just fine by itself. All we know is the lab wanted more blood to run the tests. We simply dont know enough about their protocols to know why they might have wanted/needed it.
Hope everyone has a great weekend (excluding certain individuals who shall remain nameless because any post with their name in it seems to get deleted - you know who you are and you should be ashamed of your abuse of discretion).
Wait for it...
GO GIANTS
Agreed. Whole heartedly agreed. Sympathize with the smartphone situation. Damn auto correct :)
Actually when he said mid-March he thought they would be getting test results. Delays, delays, delays explain the quiet. Not a requirement to keep P21 hushed. We will get the info when the lab is done. DF might not want a constant pr stream about the trials but P21 is something they will allow the Company to disclose.
NO PR is the LEAST of Senesco's issues and is not the reason the stock declined. Their multitude of problems are as follows. They are way way way behind (years) in their PH1 study because of two competing therapies for the same type of cancer sucked up all the clinical trial patients at their hospitals and made replacing the patients who dropped out very difficult. Plus it seems like those other new therapies have pretty much cured the type of cancer Senesco was initially targeting so that was an additional bummer to the shareholders (90 percent response rate with the newest combo therapies). They also have no other products in the pipeline and require steady dilution to pay for operations which has happened over and over again even while the trials stalled. The latest offering has led to the latest decline in price and that has been the case for a long time now. Saying that shareholders bailed because of a lack of PR just WRONG
Also you should delete your own post for talking about another stock, lol.
Wait for it...
We will get P21 and eventually and it will be good and it will come sometime this summer (though at these levels even detection at cohort 4 seems iffy). Hell it could come tomorrow given that Leo has no idea when the tests will be run. It appears cohort 2 had some kind of issue where somebody dropped out since there were 4 treated explaining the significant delay we encountered and the 50 percent dose increase. Good call Whoops. Hopefully they will tell us what dose Cohort 4 is at and hopefully that is a 100 percent increase. I think if luck is on our side the remaining cohorts will move much faster (ie month long cohorts) since the delay was due to an issue rather than just DF moving slow generally. All in all nothing has changed. Hope in the short term and in it for the long haul. Maybe this will quiet down the cheerleaders and over enthused grammar speculators on this board. One can only hope.
There was only one positive thing in this - P21 is cued up in a few weeks. More disappointing was dosage numbers. 30 for cohort 3 is hella low and meand the 50 percent bump ups have already kicked in. Also interesting they refer to Cohort 1 as Cohort 0. I guess they are planning on 10 rounds.
Exactly. Some people have trouble understanding that seeing P21 is great but not proof that the drug will work. As one said it means the engine is rumbling but that doesn't mean the car will go. It is only a sign you cheerleaders you :) Here's hoping we are told something interesting this morning. But please no crying :)
P21 would be great. No doubt about that. Still even if it is not there yet that is not reason to think it won't be there tomorrow. Now they get to Cohort 6 and don't see P21 then I say the car just ain't going to start. But I think we all know we didn't buy a lemon do nothing to worry about. Lol enough car metaphors. I walk to work anyway thankfully.
Don't get too excited about Monday and you won't be too disappointed. Extremely likely that it is too early to detect efficacy. Detection of P21 is about as good as it could possibly get on Monday. That is a 50/50 bet though the Company's repeated reference to it makes me think they have reason to believe something positive could have been seen at Cohort 3 dosing. Otherwise not sure it would make sense to call it out explicitly in the PR as they did.
Does anyone watch the market? Nobody saw the tumble that happened today across the board in biotech and more broadly. Haha. Breaking even at 2.20 is a good day on a day like today. We were at 1.50 in March. But besides that who cares. Most are here for the real money. I don't get out of bed for anything less than 12 a share :)
Actually Dr. Mennon noted at ideas that a month and a half per cohort was in the normal range. Figure dosing really got underway around New Years and we are not really suffering too much undo delay. Four and a half months for 3 cohorts sounds about right. Might move faster now because you technically don't need to enroll anymore in the 3x3 structure going forward if everyone stays healthy.