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So you believe this was the best way forward?
To have me( a scientific lightweight) and the FDA tell you and CTIX that they now need a 1B?
Rather than have Menon announce this 18-24 months ago? And pursue it with DFCI way back then?
Maybe we have different expectations for our investment
sorry- we are still in phase 1- if it gets approved, even
Or did you miss that?
Why not have done some of this 1B a long time ago?
See, that was not so hard after all-
No seriously, thank you, for missing my points
If I had wanted to say that trails could fail at any phase I might have said it
But instead you said it, in an attempt to summarize my point of view.
Only you were wrong
At least you are (trying) to read posts-
Of course it is. The problem is, why did it take ctix so long to realize/announce there would have to be a 1B? why not announce it a long time ago? Why not have done immediate testing of multiple doses per week with multiple cancers? why not ask DFCI and BI for testing of the dosing intervals they planned to use for years probably, given the very short half-life? That could have started already, months ago.
Instead we wait while they ask for a phase 2, and then are reminded by the FDA that they need a 1B to establish safety at multi week dosing intervals-
Do you really believe that?
Of course that is how it is presented- and that is what the FDA and ctix will prob agree to
But it has no real meaning
Look: apr-246 just did well enough in its 1B to get funding and move on to the rest of its 1B/2 PISARRO trial. Would it proceed if there were no efficacy?
Not a chance
1B is the reality here now. Phase 2 is a maybe
why didn't Leo announce that we would need a 1B along time ago? why isn't it already in progress?
A pseudo scientist such as myself(medicine) could see that the dosing was an issue going forward, as I have written too many times, and NOW we hear about it from the company? Sigh
and yes, again , I know that 2 might follow 1B
But it might not- 1B will have to succeed, with efficacy, just as apr-246 recently succeeded with its 1B
yes I noted that.
But we start with 1B of course, with safety still NOT PROVEN and with the certain prospect that lack of efficacy in 1B will put an end to Kevetrin dreams
Expansion of p53 ovarian CA trial sites-
oh yeah not ctix
it's COTI-2 : Critical Outcome now announcing they have a second site in Chicago after starting work at MD Andersen in February, for, you guessed it, ovarian CA, soon to be targeting, you guessed it, endometrial CA and AML.....
ASCO 2018- 1B results for Kevetrin in its ovarian CA trial. Just 2 years behind aprea 246...
We will know before then if there are any signs of efficacy but that should be about right for an official coming out party.
Or for a focus on the possibilities of Brilacidin if K is a no go.
ASCO 2016 Ovarian CA p53 drug 1B results!
Only problem is that they are the results of APR-246, which looks like ok response at first glance, no careful look by me. This was part of the data they had prev announced as part of their drive for funding and starting phase 2, not just in europe and sweden but also in the good old USA
Get ready for 1B!!! Not phase 2 for AML or phase 2 for ovarian CA or phase 2 for renal or pancreatic CA. No, get ready for one 1B study, all hopes for Kevetrin now centered on those next patients.
Here is hoping that CTIX is putting their eggs in the right basket and that ovarian CA will be the best choice of initial focus, as already shown by 1A enrollment trends.
Is there behind the scenes testing that we do not know about, where tumor samples suggest a best response from those patients? Presumably there is.
On to phase 1B- maybe the company mighta mentioned this would be the case about 12-18 months ago? When it was obvious? At ASCO 2015 we might have heard that multiple weekly doses were already in progress to prove safety.
Next K data ready for 2017 ASCO- not very likely
surprise surprise surprise- ctix announces what I have been ranting about for some time, that safety was never established, that p1 will continue because multiple doses of K were never given as part of what we will now call 1A.
How much insight did it take to realize that there would need to be more study of safety at different doses? Essentially none, it was obvious. And yet the company was saying it was on to p2 and that there was plenty of pharmacologic data available.
Welcome to phase 1B of Kevetrin- we knew it was coming, and now it is announced. Finally we will get to some make or break info. As they dose 3x or more per week will there be signs of efficacy? When will we know ? one year? Two years?
Since they have placed their eggs in the ovarian CA basket, the planned 1B trial may be the last trial ever for K, for any cancer, if there is no efficacy.
Why oh why couldn't phase 1B now already be in progress, done as part of an add on to phase 1.
Woops- I mean phase 1A
also lost wife's sister to pancreatic cancer at young age that in part explains my investment too.
But look: Now it's a 1b/2- no surprise whatsoever to me- I have been posting about the dosing problem for months. Leo wrote me and said we have a lot of PHARMACOLOGIC dosing data, yadda yadda. Big deal- they are now due for phase 1 b trial AS WE ALL KNEW tHEY WOULD BE. Why this pretense- so much dosing info, headed straight for phase 2- BALONEY!
Where was the add on to phase 1, to get us to repeat dosing weekly, where we now sit, waiting, waiting, crickets, waiting.....
Why not have dosed pancreatic and renal and ESP ovarian 2-3-4x week as a follow on to phase 1? As a new protocol submitted to Dana Farber and to BI to ask about multiple doses per week? For multiple cancers?
THOSE results could be presented at ASCO now, maybe, and might have sent the stock to the moon. And proved the worth of CTIX to big pharna, and put us on the map.
BUT NO- now we wait for another year or two at best, with a focus on ovarian CA, as everything else is on hold.
Biodoc, or others who know- I do not, I freely admit. Could Leo have said to DFCI : hey guys, could we dose 3 - 5 patients with ovarian and renal and AML and pancreatic CA with multiple weekly dose to get a better sense of PK/PD data and to see if there is some sign of a response???!?!!
BECAUSE THERE IS NO REAL SIGN OF A RESPONSE - YET.
But no, that is not the course they chose and now we will quietly sit here, in the corner, waiting for the ovarian 1b trial.
Do you want to know what this really means? It means that CRISPR technology to change the genetic code- yes that is correct folks- CRISPR treatment of genetic problems- will have more time to solve every genetic problem? Are you paying attention? CRISPR for this and CRISPR for that- soon it will be CRISPR for p53.
And then where will CTIX be?
At this point I am still somewhat of a believer, but I am getting nervous, AND THEY NEED TO START THE TRIAL ALREADY!!!
OK- let's say K fails- and it may well fail, or be obsolete. I still believe Brilacidin can carry CTIX. But c'mon guys, c'mon Leo- you said B-UP trial would start in May. So what about it already?
Step up to the plate CTIX
is there even one bit of actual new info in the pr? will not get a chance to read carefully today.
yes you are right in part, but biologics are for a certain population only and the big question is, how about treating all the other psoriasis patients who may not need a biologic, or have stopped responding, or want a break in treatment?
For all of those patients- sometimes perhaps even the very same patient at different times over a very long and persistent disease course-the ability of a company to offer a range of treatment/meds is compelling.
Wouldn't they rather make the big bucks with the v expensive biologics? Maybe so. But each patient will have different and varying needs- lots of opportunities for other products in the mix
How to understand the lack of response to the P results?
Most important is the results were suggestive not definitive, with very small numbers, as has been discussed here.
But at least in my eyes the results are good enough to be excited about, although , admittedly, I had very low hopes for trial success, and that might color my view.
I have been reading more about abacavir-Ziagen side effects, and those of apremilast, to try to see if that has anything to do with lack of interest in the stock. I have already written a bit about the other common oral approaches to psoriasis, methotrexate and cyclosporine, which have serious adverse effects, so it is easy to see why other oral agents have appeal.All side effect info is as listed on current "Up to Date" reference
From what I see the neuropsych effects of apremilast carry a warning, but under list of significant reactions it lists depression at only 2% It does suggest use with caution in pts with a hisotry of depression/psych concerns, though.
Main side effects are GI which are nausea 17% diarrhea 18% and -wow- weight loss of 5% in 19% of pts and weight loss of more than equal to 10% in 6% of pts. These are striking numbers, right? Obv some very large percentage of large Americans would like to lose that much weight but tough to do it because of nausea vomiting and diarrhea.
Miscellaneous other side effects- rare respiratory,
6% headache.
Also important- dose adjust with signif decreased renal function
So how about abacavir? yes different salt but much of the side effect is bound to carry over- how exactly no one knows, I suspect, but enough to get a sense of things
Main worry is the hypersensitivity which is screened for up front as is well known. However, what is the rate of hypersensitivity for those without the allele? For a potentially fatal reaction? I will need to spend more time with this issue, since it is critical, but Up to Date says it is 1% in the non 5701 population.
The other stuff is headache - more than 10%, and then miscellany 1-10%, such as odd dreams, chills, dizzy n,v,diarrhea, bronchitis, pancreatitis, increases in liver function tests, myalgias, decreased WBC and platelets.
less than 1% anemia and fat redistribution and potentially truly serious lactic acidosis
So is this enough stuff to warrant a lack of interest by big pharma? Will it hinder moving forward? Obv all of this data was very well known by CTIX prior to setting things in motion with prurisol.
Just trying to understand the lack of interest in ctix despite promising results- not definitive- but not bad
It is weird.
So the data for Prurisol are not sensational. But they are still very encouraging.
Maybe lots of buyers at very low prices were hoping for better trial data, more definitive, and are taking profits and looking elsewhere
I do not know.
I find it surprising and discouraging
?B-UP trial start? 10Q said start in may
Or maybe it has already started in its undisclosed location, and the start if the trial is also undisclosed.
I mean, seriously folks, why disclose it, with a press release, when all the press releases seem to lead to declines in share price.
Sigh
the assumption would be that a deal with more data would be a better, deal and that is likely right I suppose it all depends on what Leo could get for licensing Let's say 200mg BID has a success rate of 60%, he is bound to get a much better deal, right?
I think your argument is correct and they should first look for responses at other doses in another phase 2 trial
I wish they would just push forward with other trials for K, for pancreatic CA to take an example, and money from a deal for P might get them there much sooner. But how much sooner? By a year? By 2 years? For such a tiny company they have a lot on the plate
It is very helpful and sobering to see just how small the numbers are that make up the response rate. Looking forward to next trial at 200,300,400mg
Thanks for doing the math
up to date systemic therapy for psoriasis summary
if you read through the treatment section for psoriasis for the most common reference for physicians-Up to Date- you find the following:
Biologics- very effective high response rate inconvenient some serious side effects and extremely expensive If you have severe disease will you take these drugs anyway? yes if do not respond to easier regimen
Oral therapy
methotrexate- around a long time, inexpensive. trials show response rate of about 36% but very variable some very serious side effects most famous is liver toxicity
cyclosporine- at medium best tolerated dose of 5mg response rate 65% BUT trials comparing head to head methotrexate cyclosprorine have shown not much difference in efficacy For cyclosporine some serious potential toxicity esp renal
apremilast expensive efficacy about 30-35%; some real toxicity but usu not so severe as mtx/cyclosporine commonly nausea- can post better list of side effects if need be
oral retinoids also given but small numbers of pts in studies
What does this tell you?
Clear cut space for Prurisol if a phase 3 study confirms benefit. None of the other oral agents are likely to be superior in terms of efficacy and a couple have serious potential for downside- for example, need to monitor CBC and liver tests with mtx and need to check renal function(creatinine) with cyclosporine.
Looks like it will work at least as well as apremilast with fewer side effects prob and less expensive likely
Hassle for Prurisol? test for B*5701 mandatory and will exclude up to 5-6% of patients. Not many excluded, therefore.
Phase 3 at same and higher doses will be informative
a key difference Leo does not mention is that apremilast does also treat psoriatic arthritis. However, that is not the majority of those with psoriasis, it is about 30%, according to what I v quickly looked up. Never any mention anywhere of Prurisol and arthritis
This 46.2% response rate is very good
Have not had a chance to look through all the numbers yet
Speaking of precision medicine, prurisol is a perfect example of the issue, given the abacavir hypersensitivity to those with the allele HLA B*5701. Nice discussion with many other examples on wikipedia
I agree. Quick and dirty summary that shows just how surprising it is that a very small company like ctix can have so many drugs moving forward into advanced phases of trials
K/B/P and the near future
another edition of NEJM tomorrow today: 2 interesting articles this week's NEJM.
first entitled seamless oncology-drug development, talks about the usual approach to onc drugs of promise vs an accelerated approach. Not too surprising I would think- but here we are with K- the usual phase 1 and now phase 2 coming up.....at least promise of acceleration-
next is a brief note about precision medicine, the recognition that genetics rather than race /ethnicity is what is more important for drug trials. It seems so obvious now to write this , right? And yet the pharmaceutical/medical trial world has always used ethnicity.
Medicine is moving beyond its previous categories to new and better definitions and stratifications - excellent.
C'mon Kevetrin, let's get out there, with some sort of accelerated p2
Look no CTIX at ASCO 2016. What about 2017? Prob not, right? Ovarian Ca trial will not be advanced enough to report results.
So there you have it: ASCO 2018 or even 2019 for our company to make a splash with K...
For the next couple of years this stock will be driven by Brilacidin and esp its anti inflammatory capabilities, and by Prurisol- who'd a thunk it- rather than by Kevetrin. No more K headlines for quite a while- unless somehow we get updates about pancreatic ca and renal ca. Woops- 10 Q just said focus on ovarian, so forget the others....
Yes Leo confirms HLA B57 pts excluded for the trial- and for the future - approx 6% of population
much bigger news would be if any benefit for psoriatic arthritis....
10Q says phase 2 proof of concept trial for B-Up to start May 2016
so some news likely pretty soon
you are crazy to sell now, unless you just have to have some cash
Leo has suggested some news about B-UP in the near future and maybe he will have something to say about B-OM too. he has said they are moving forward with B-HS They added Sonis and Farraye- they are not doing all this for no good reason
(Plus there are some here who think that starting Bp3 and K ovarian p2 will matter to share price)
unless ctix is withholding key trial info- and we do not know all details- this is a MUCH better hand than a pair of 7's. The very least important drug this company owns did very well for moderate psoriasis patients at the 200mg dose
Yes more proof needed
Yes questions about big pharma interest in Prurisol as prev detailed
But this is very good news for all shareholders Ii think
How can it be bad news?
More proof required? OK, that's all right
Wanna see all the data? Sure, ok
Will people take a retroviral drug for psoriasis when they have alternatives? Remains to be seen, but, why not?
It is very good news and we are better off today than a week ago for sure as shareholders of ctix
Hey get ready for B-UP news-
wrote to Leo for clarification
hard to believe they could avoid genetic pretesting because a serious AE would be a problem
also: better for them to clarify specifically rather than for us to guess, though
a good question
if 35% at 200 mg respond vs 16% is there no significance? because so few patients in that group is the likely answer- small sample size
BUT it is encouraging and no doubt p3 will have much larger groups for 200 mg, and prob of course higher doses too
interesting. I think they did not put it in because it is so well known and so well described. BUT pls refer back to discussion between you and KMBJN post 74347 where the original trial abacavir vs prurisol bioequivalence specifically mentions testing for HLA B57 whatever allele.
and yet not mentioned in the study requirements you attach
i think they forgot to include it since testing prior to treatment ESSENTIAL
Have not read over protocol in detail- but the sensitivity reaction is severe and so testing prior to treatment is mandatory and would have to be part of the protocol
remember the hypersensitivity issue with abacavir- a BIG not a small deal. But once you have the genetic test it is ok with adverse events so far as we know
I was just trying to understand the muted response to very good news.
Will big pharma hesitate given Ziagen history? I would think having a very long track record with a given drug would be a plus(yes I know the salt paired with Prurisol differs...) despite the fact that it is a retroviral drug
maybe also big pharma nervous because mechanism of action really unknown....
exactly so- p3 would have to look that rate of efficacy-side effect, but results so far very good on their own
how could people not be buying?
agree completely of potential for prurisol compared to apremilast given available data
ok then, what is the downside for abacavir? From a marketing standpoint: requires genetic testing and it means people will take a drug usu prev given for HIV patients. How will big pharma view this for potential partnerships?
If you have moderate psoriasis you want to get better with few side effects. Prurisol looks to fit that bill and there is room to include patients on the worse side of the spectrum of disease for p3 given report about moderate patients showing more benefit
The least important CTIX drug has good p2 trial results- very good news. Plus there is hope that a higher dose might do better-
?share price down on such good news
I bought more when I saw the headline I never expected to see- pretty good results I thought. Only to see price tank....
And more good news: we know that there is more info coming out soon about B-UP and HS.
I am very pleasantly surprised and look forward to reading the results more carefully
if statistics are easy you do not believe that results released later rather than sooner is a concern? Not even a little?