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CTIX on 6/1/2015: It is like getting ready for a major flight. Those first on board, first to spot CTIX, got the seats up front, and they got the aisles and windows, and that is us. Any current shareholders is us. We are in line for take-off, and the pilot tells the passengers that we are third in line for takeoff, and asks the flight attendants to take their seats.
This is the precise moment, as I see it and as I feel it.
IF Kevetrin shows efficacy over the next whatever months, the CTIX plane will roll forward and begin that rush down the runway and lift off the ground and start that steep climb up.
Even without Kevetrin we will have an excellent flight with Brilacidin as antibiotic and anti-inflammatory, and the trials underway, and to come, are just the last few checks before take-off.
Of course I have been wrong before about stocks, but that is how this feels to me. And I suppose you could argue that we are still boarding the plane, or even getting ready to board, at the gate, and I would accept the metaphor(or simile).
A few more bags to put away, a few more checks before take-off.
And then -you knew this was coming, right:
Make sure your seat belts are fastened!
I cannot tell if you are being serious or not.
Like everyone on this board I see CTIX potential on many fronts, and that is what makes it compelling as a small company. To have a cancer therapy and new antibiotics and defensins that will have real impact in inflammatory conditions- that almost defies belief.
Just hoping more of it pans out.
What he said. Kevetrin poster should have been rejected by the standards listed.
Yes I agree with both of your points, I think they were clearly spelled out as 1, and then a 2.
As I posted prev, Shapiro shoulda put up a poster that should have just said "See you next year!" in big letters, that is how helpful it was.
With such severe limitations why did they choose the data they did release? Why tell us there is a range all the way up to 200%, but that half of pts had no response? If they say that , then why not something about 350/450 as announced by Leo on 4/21?
Your response- because there are severe limitations on data release is true- BUT there is data on the poster, so they can pick and choose.
My main concern over the weekend was the big flurry of everyone saying how wonderful it all was and how we learned new stuff. Nauseating, really.
At least your post clearly explains that we cannot learn new stuff about an ongoing trial at ASCO
Even though they did put some data up that was sorta new- here we go again.
Once again i would ask you : how has does the Kevetrin poster contain any data then? It violates the rules you have posted.
On a lighter note though I do appreciate the sarcasm in your response
Nota bene : abstract rules, NOT poster rules
You are suggesting the current poster contains no data ? None? really? Maybe re-read...
I have talked to him by email.
Oh yes - the same rules that bound their 2012 and 2013 posters not to mention this one where every poster has plenty of data? Give me a break
Please sir? Can I have some more?
No one can be bothered to second your sentiments, and say here, here, show us some actual data? (As suggested back on April 21- corporate update).
Well I am with you brother and it is beyond belief that the board just swallows the koolaid and says how much we learned from ASCO and how great it all is. Without even meekly raising a voice and saying please sir, can I have some more data?
Less is more? ASCO vs CEO update 4/21: For those of you who somehow believe erroneously, that ASCO was such a big deal(yawn) let me point out that on 4/21 we were told something potentially important, but is it true? CEO stated that 350 and 450 mg cohorts showed dose dependent response in p21. Not mentioned by Shapiro.
ASCO actually provides you LESS information than you knew before. Since when is less more?
Note shift at higher doses to ovarian cancer and endometrial cancer.
Have you ever made a mistake? Or written something in haste? Or written something you wished you had thought through before you clicked send, or clicked submit post?
Sure I have.
But : I would not knowingly post something false here
And I would expect other posters who occasionally put up demonstrable nonsense to say, woops, shoulda thought it through. This of course assumes that one can recognize nonsense. So then tell me : if someone says that "kevetrin induces apoptosis in cells independent of p53 status" is new information and it has been stated for a long time already, and it is easily demonstrated as false, should that poster come clean?
Is old news still news? Because if it is, then your summary is really helpful. On the other hand, if news is supposed to new...that's a real hurdle.
Ignore false posts? or try to correct them? If the board is willing to simply ignore simple basic false statements, such as those asserted yesterday, what do you do? Conclude that the board is truly clueless about the most basic science with Kevetrin(it woks with both mutant and normal p53) or conclude that no one really cares, and they just write whatever? I am unsure. There is plenty about p53 that I am clueless about, and the scientific community is clueless about. And there are times I write things that aren't true. I would hope at least to say, sorry, got it wrong, and move on.
I will say that I think that CTIX has a potentially amazing future, and on that we all agree, probably.
I will try to respond at some point about the poster info / no data rule. How does the current poster have any data then? And how do the 2012 and 2013 posters have any data?
My guess would be that you can go to ASCO posters and see all kinds of data, but I have not done so, other than the prior and current CTIX posters, which DO have data.
Boy, it was really hard to find the same info in the sentence that Drano claims is new. How about looking at the Cellceutix site to find the ASCO Kevetrin poster for 2103.
There you will find in the opening paragraphs and in the conclusions-which are highlighted-the exact same info. Presented by the exact same speaker, Dr Shapiro. About the exact same topic, Kevetrin and the Dana Farber trials
it is very old news- and by the way, it is part of the basis for all of the hoopla over the drug. Which is that it works on cells with both mutant and wild type p53. But that is why all of you are invested here, right? Because of the science?
where is the corresponding dose for the 3% increase and the corresponding dose for the 205% We do not know because it is not presented Nor are any of the other data points that we want to see
So it's all in the presentation, and not on the poster?
Well, that is welcome news. Actually, I really hope that is the case.
I doubt the quote that you have singled out is new at all. Would you care to guarantee that it is new? I bet we can look back at earlier PR's and earlier ASCOs and find the same statement. That is, after all, in how we have been told that Kevetrin works, in part
But that's OK- people can still keep saying how great it all is without anything to back up their opinions.
lots of studies show that you cannot change people's minds with the simple facts.
And the facts are simple here folks.
But I won't bother to repeat them again
I suppose you must find it hard to ignore a voice of reason
Let's see- I thought I was on the side of science, but you called me a holy grail craver. The bloat belongs elsewhere...
Agree with much of what you said
let me sum it up, as I said earlier.
Come back next year when we have a poster about whether Kevetrin really works.
The CEO should not give more news in an April PR than the lead researcher does at ASCO
craving...holy grail...sure I'd take that. but instead, how about something simpler, like following up the CEO's corporate update , where dose related increases in p21 were announced. Is that too pie in the sky for you?
Maybe a graph or a chart with some real information in it?
I guess that is just crazy craving holy grail talk.
Gimme a break
What is sad is the lack of data.
heck I'd take even p21 data that was new. Let alone tumor response data.
Woops- nothing new. In fact, those dose related increases in p21....I keep looking for those numbers, but...maybe you, or other board members, can point them out.
So what is your take on the promised dose related increases in p21 from the 4/21 PR , and more info at the appropriate venue?
Yes, I know what phase it is. Why did the CEO make those remarks? Now to provide nothing new...
What are you guys smoking? Poster says nothing new, nada. The poster should just say "To be continued, when at some later date, we might be able to tell you if the drug works"
More important, the poster does not even say boo about any dose related increases in p21. In the 4/21 corporate update the CEO said there were dose related increases- so WHERE is the data? Oh yeah- we were waiting for the appropriate venue. For CTIX to say....wait for it...nothing new to shareholders!?!!
Please re-read the post I reference above where I describe the ASCO conference presentation, in advance, and sadly, I got it right.
No mention of efficacy that was new at all. Same refrain of half(48%) had greater than or equal to 10% increases in p21. BEFORE it was more than half.
No details, no info on dosing related increases, no patient info about any responses to K. Zippo.
If Leo is so optimistic, then show us the data.
Unfair, right? For efficacy maybe needs 3-5 x a week, and that trial has not been done yet. So then why all this best is yet to come and IRB yada yada enthusiasm. What is the basis for all that enthusiasm? No one has stood up and shown us shareholders anything remotely suggesting efficacy.
Dr Shapiro, does Kevetrin work? I don't know, but it is really well-tolerated- see ya next year
C'mon CTIX: Not even word one about efficacy? Not anything? Sadly, just as expected.
Why does the CEO take such an optimistic tone? What do they know that we don't? This is the "appropriate venue" so stand and deliver.
More news in the talk itself?!?
Agreed , I am no scientist either. Much more comfortable talking about clinical medicine. My wife is a biochemist and she finds my struggles amusing.
Of course you are correct.Anything along the way of the p53 pathway ,other interactions, could be the problem- MDM2, HSP90/HDAC6 etc
The HHMI video is just the simplest intro obviously. I watched the singing guy and started on the Indian fellow with the headphones!
Yes looking for more complex animations etc
Too generous. I struggle with the science, but hey the struggle is fun.
OK here's a challenge. Science driven stock, right? My brain and understanding are partly driven by seeing something to understand it(Duh). So who can find the most beautiful explanation/depiction of how p53 works in a web available video.
I just started working on this and there is a nice intro with good animation at HHMI Biointeractive p53 and cancer
Please find me a better video and I will appreciate it
Just for kicks, guys and gals, to get at how mysterious this all is, despite so much being known. Click on the Cell Death article referenced by slcimmuno and then look at figure 1, the extended version. It shows the frequency of various gene mutations for different types of cancer. For ovarian, for example, ALL of the leading mutants are p53 mutants. Look at the graph: it is amazing.
And then look at AML- p53 mutants are not even among the leaders at all. And the same is true of renal cell cancer, graph also shown
And yet- where is K's first 2/3 trial? it's for AML!!! The cancer it did so well against n the original ASCO poster, if you want to go back and look it up.
And the other trial we keep hearing about is for renal cell cancer with Beth Israel with sunitinib.
How interesting is that? Two cancers where p53 mutants are not the big players, and still Kevetrin works well against these tumors?
Pretty interesting I would say.
Ovarian cancer as a target would seem logical- but how much don't we understand?
So nice of you to summarize a bit. When I read through such an important and chock full of info article I get lost in the trees ...
Some takeways: p53 has 393 amino acids and most have mutations expressed in cancers. A few of the mutations for p53 occur frequently in lots of cancers(the most common one is the 4th most common mutation seen with all cancers considered).
p53 mutations are overall very commonly expressed in various tumors, with a lovely table showing this distribution- almost all ovarian cancers, for example. But of course this includes all of the p53 mutants, and there are many!
As KMBJN just stated, just deleting p53 does not produce in mice the types of tumors found in humans BUT specific mutants do produce similar tumors.
Such an article helps me understand how complicated it all is. And I thought I knew how complicated it was yesterday. This review article helps muddy the waters, and bring them into focus at the same time. Certain drugs targeting p53 are likely to help with very specific tumor types, and there are many different ways to target mutant p53 action.
Learning how and if Kevetrin works in people will be fascinating.
What a find by you slcimmuno- most details I have come across.
In or out: how would you like to be out if they announce real efficacy?
Ugh.
That could ruin your whole day
How sweet it will be if there is anything significant about efficacy to be announced tomorrow. If not, good things may still come as dosing increases.
What is interesting is the very positive tone taken by CEO regarding IRB decision, new dosing. Does this optimism mean there is much more to say about efficacy? Even at the current once weekly dosing- when we know K is headed for multiple doses per week? When any positive effects ought to be greater?
I have gone on record saying I think they won't have much to say tomorrow about efficacy and yet I still wonder given the optimistic tone
Now I get it, I think. The p53 that accumulates in cytoplasm is good old wild type . Somehow I thought it was mutant.
CTIX corporate update already said that p21 went up in dose dependent fashion, and yet the world did not shatter. When tumors start responding regularly(not just one spleen lesion)then the world really will shatter.
But look- what will it take for patient responses? Higher doses on multiple days? Not even fair yet to judge K, but of course we await the next word on Saturday
Regarding slcimmuno finds and Kumar response: Prev came across gannetespib when looking at p53 drugs on clinicaltrials.gov.
It is the recent Nature paper drug from Stony Brook. From Synta Pharm. It has many mechanisms of action, incl interactions with multiple oncogenes.
Lots of trial in progress, easy to search, including an AML trial with cytarabine. Also Non small cell Lung ca(NSCLC), a trial called Galaxy Beautiful little video on the SNTA website to describe MOA.
Worth keeping an eye on, since it is a sort of competitor , but will need to learn more about it.
Thanks for details. It is a puzzle.
My guess is that what they have written thus far means attempt to cure oral only and not esophagus, joining a group of swish and spit meds(say for thrush, oral yeast infection).
Talked to a radiation oncologist today(my sister) who says that an effective treatment for mucositis esophagitis would be a BIG deal and she and her patients struggle regularly with this issue. NO GOOD treatment options currently and problem gets so bad that sometimes a feeding tube is necessary.
Would the rinse address oral only or include esophagus? I do not know. Swish and spit? Swish and swallow? Rinse sounds like spit after swish inside mouth, so maybe oral only and not esophagus, which she says is a big deal.
Good potential here.