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how can they start until we/they know dosing for Kevetrin?(Yes I wrote Leo back again about this, no answer) Will it be 2017 till add on patients analyzed to determine dosing/side effects?
Of course there would be no placebo since FOLFIRINOX current standard of care. I would bet that of 47,000 new cases in US most start chemo rather than palliative care, though have not looked up the numbers
I am excited about the collaboration with Mayo too- it is a very positive development
New PR excellent again
How much is new? Was looking over the original American Chemical Society poster 2012 and much of this data was reported there 3 years ago, when info about a variety of cancers was presented and data regarding mechanism of action, including the pancreatic cell line referenced in today's pr.
I have no idea if Mayo/Kevetrin will get the grant they are applying for, but it really matters not. What matters is that Kevetrin / CTIX expands its reach out across America and into the conference rooms of people who can start patients on Kevetrin once dosing is established.
When will we know if Kevetrin works in actual patients? on its own or with other drugs? 2017 guess by frrol prob right, UNLESS they can really pick up the pace
realistically we are now tasked with waiting for real info to the end of the add on/extended portion of phase 1. I will have to re read press release to see what they called it
I said I knew nothing about it.
That was why I took the time this morning to read up about their involvement/expertise in pancreatic cancer, and why I wrote a very positive write up about Mayo/pancreatic ca this morning at 7:47
I write this simply because we always talk about how great the new multi week dosing might be for EFFICACY (essential of course) but we do not talk about such increased dosing frequency in terms of SAFETY
as always you find an amazing array of helpful info; thanks again for reading material.
The word of caution regarding Kevetrin is simple: short half life means no real chance to demonstrate efficacy thus far, but also, perhaps, no real chance to demonstrate adverse effects. I have written on the board before about the lifespans of white blood cells as one possible problem- this was an issue with MDM/X drugs .
When will the add on to phase 1 start? What will it show? Kevetrin safe so far in phase 1 with a very short half life drug given WEEKLY! what is next and how long will it all take?( Yes I know I keep writing the same thing - but it is critical info)
why Mayo? unsure how many of you have already done this- I suppose it depends on your work schedule. I have the morning off, so:
look up pancreatic cancer research at Mayo, and you can find out some stuff of note. One thing is that it is a SPORE for pancreatic cancer- specialized program of research excellence. ( Of course you will recall that BI Deaconess here in Boston is a SPORE for renal cell CA, and that has not helped us so much that we know about) It treats 1900 patients yearly with pancreatic cancer in the US(45,00 new dx yearly US)
There are 17 people listed on its research page, some of whom are in Scottsdale AZ and Jacksonville FL- its other centers as you may know. Some are in genetics surgery etc and cannot be linked to press release. 3 names caught my eye. None of them trained at or worked at Dana Farber or programs based in Boston.
3 names stand out.
Erlichman-prev director- through 20015- of Mayo cancer research. Research has focused on HSP 90 stuff, something called 17AAG and one other, long name starts with g. Also works on inhibitors of EGFR.
Alberts-current cancer clinical research director for Mayo. Works with Nat Cancer Institute GI group, and is on some Pancreatic cancer task Force. Interests in early drug development/trials
Urritia- interested in cell growth etc Very picky lines of research, but his papers are listed and #10 includes a mention of a p53 isoform
I have a limited understanding of cancer centers and research, very similar to man on the street survey, which would pull out Dana Farber and MD Anderson and Hutchinson and Memorial Sloan Kettering as big centers of excellence.
It would appear that Mayo has a lot of focus on pancreatic cancer, many published papers coming out, lots of trial expertise, and also, LOTS OF PATIENTS with this unfortunate cancer. This is an excellent affiliation for CTIX- should anything come of it. This remains to be seen of course.
I cannot see any instant connection between CTIX and Dana Farber and Mayo, other than they all know each other through papers and reputation I would think, and they see each other at ASCO
You must be right about this very nice find. It would be so helpful for CTIX/Mayo to say more about the collaborative work the pr mentions. We would all like to know how much real info/data goes into the application. If releasing the Mayo connection why not say more?
How can they be moving forward when the company still has said nothing about phase 2 dosing, or about the next add-ons to phase 1 for multiple x week dosing? Presumably the company knows more than it is saying. But if that is true, why have the extension to phase 1 at all? If they can already set dosing?
Why buyout this year? I cannot see Leo selling until the company has a proven winner, or 2. Why not wait to see if Kevetrin actually works, since it may well work.
If K and B prove actually truly successful he can sell out for $200 a share instead of $10 or 20.
I am thinking 2019 or 2020
good news but huge? no idea if K will help pancreatic ca patients or not, and the answers will take years....
I do not know how good Mayo Clinic is for oncology but it has a large patient base and that would count a lot in a trial.
Also such a good indicator that CTIX is talking to other oncologists and getting the drug out there. This is really excellent news
odd that they wrote about 1278 when ctix mentions 1807 as their focus
unless i have missed something recently
re Kevetrin dosing decisions time frame:
The 11/16 pr and the pr from yest talk about the hopes for K phase 2 ovarian with the clear unmentioned problem of what dose will be given. What is the time frame for the decision, let alone the decision?
Will this await the add on to phase 1 to determine a dose? That could be a yea, or two years. Will it be based on pharmacokinetics alone and can be determined from phase 1?
Highly doubtful, right? If such a leap were possible then why do the add on to phase 1? Or is the add on to get more info on pharmacokinetics PLUS safety info at the more frequent doses?
We keep talkng about K news- but seriously folks, any real K news is in the distant future in all likelihood. The end of phase 1 will tell us nothing we do not already know.
Have the even started any add on patients yet? We woulda heard I think.
insights on this topic- none sorry. Not enough of a scientist to speculate.
I understand that the apr246 works in different ways, and believe me, all I read and write about on the board is about how complex p53 is and I could not agree more that there will likely be many drugs that involve p53 in the future, and yes I hope that Kevetrin is one of them.
Just wish we were further along- that is all
Shapiro and Menon and Leo know no more than we do I would bet, about the key question of efficacy. DF and those researchers put in the time because that is how science works. Of course there is the chance it will not work, or have some unforeseen side effect.
Follow up to prev post about the use of CRISPR-cas9 to illuminate mechanisms of action of p53 drugs: for those with general science interest there is a truly amazing article about the background to the discoveries in CRISPR technology- can find in Cell online by Eric Lander, just out, called Heroes of CRISPR. Fascinating story of how science works, with many fun facts, for instance, about how how key papers -for people who will share a Nobel prize one day for their work-were rejected by journal after prestigious journal.
unsure what you mean, don't compare?
further Kevetrin ovarian phase 2 comparison- dosing started for the Aprea trial(PISSARO) on April 16 2014 with 4 trial site 1 in Belgium and 3 in the UK. So for ovarian we will be at least 2 years behind a p53 trial where they have have 4 sites to enroll patients in the trial.
It has been suggested by those who know a lot about p53 that Kevetrin is a better drug, but of course no one really knows
It is not clear how many patients have any benefit. We have heard about the thymoma guy, who sounds as though he benefits. The "disappearing spleen lesion" patient had a rising CA-125- was she improving, really? Ascites also stabilized in the report. Maybe she was.
But we have no real info on efficacy now and we will not have it for a long time
Agree with you that hearing about the start of a phase 2 would be great. We all, collectively, cannot wait, of course.
And yet, so far as we know, the added on dosing schedules for Kevetrin, the multiday regimen, have not been tested, and perhaps not even finalized. Will there be an ovarian trial start with those multiple x per week dosing done for the first time as part of the trial?
Or are we still waiting for a post phase 1 Kevetrin dosing add on patients- as the company suggested a long time back now, post ASCO.
I wrote to ask Leo this and did not hear back.
Assume the worst, then- how many more months of such a trial before the phase 2 ovarian trial starts? It could be a long time.
On the other hand, let's say they dose it 3x a week and start to see improvement in patients- we will hear about it I suspect.
A worse case is we have the add on patients for mutiple x a week dosing and it makes no difference and the only time we see patients living longer is when they take K plus some other agent. In this respect APR-246 way ahead of us- they have been enrolling women with platinum resistant tumors in their trial for a while now, and CTIX announces they plan to do the same.
But in the meantime we wait.
Oh yes- the patients wait too- Alan Rickman died of pancreatic CA, as you prob heard.
Look- the company and Dana Farber are champing at the bit even more than we shareholders are, in all likelihood, to get safe and effective dosing in place. It just takes so long to get there.
Poo pooed? Are you kidding me? What a verb choice.
Maybe you should ask CTIX why they feel the need to modify 1807? Has that occurred to you?
I cannot tell if you are serious in your expertise- it sounds a bit over the top. But Ok let's assume you are right and I am wrong- this headline as written still sounds wrong to me. What can I say?
Snape gone...
OK my usu posts are snide or trending toward an understanding of the complexity of p53 or looking forward to Brilacidin becoming available in emergency depts worldwide.
But who cannot be saddened by the recent deaths of Bowie and Rickman. Who does not love watching Queen perform Under Pressure? Check it out on youtube. But I was much more a Rickman fan with the original Die Hard and then the Harry Potter movies which I shared enthusiastically with my kids.
Here's to Kevetrin and the coming trials, which may really change lives, such as my sister in law who recently died of pancreatic cancer.
I apologize for a sentimental post but so it goes.
Please let's move forward with the trials-
maybe move "in more than 20 years" to follow "first new class of antibiotic"
o/w suggests a long time till the trial gets underway.
Yes I know- stupid response. But there is a pattern of press releases with minor grammar issues
It's a little bit like a recent event here in the Boston area- the chain City Sports slowly going out of business. Why buy shares today when you can get them for 10% or 20%, or maybe 50 or 60% off in the near future?
Ugh.
It is the same old news about the new dosing intervals that CTIX has mentioned for quite awhile, I think. Remember they went back to Dana farber to get new dosing approved, post phase 1 phase 1 extension who knows what they call it
And is it ongoing?
Pretty exciting stuff? repetition of the company's pipeline info that could come off the website with nothing new of note.
We are all starving for news that is not available yet
is this the thymoma patient we have heard about before?
I think we know the answer as well as does Menon or Shapiro or anybody
Which is that NOBODY knows how well it might work because it has not been given in the ways it will in the near future: 1) multiple x per week dosing at higher levels, and 2)given in combo with many other possible agents. Ovarian CA trial will be the first time we get a real look at where Kevetrin may find its place in the hematology/oncology universe
Toward that end: any update on ovarian CA trial? Any update on any other combination trial- renal cell CA trial at Beth Israel, for example?
Most basic question: has there been a final decision on ovarian CA trial for the dosing of Kevetrin? 750 3x week? Or is this still undecided? 2x week or every other day or use a pump or whatever?
Thanks for links. Read through part of first article which has helpful graphics - so complex.
I spent a few minutes this morning reading through the colorectal stuff from Singapore re apr-246/prima-1met.
It is in something called Oncotarget 2015
it is the equivalent of stuff done by CTIX for K along time ago in terms of trying K on grafted tumors in mice.
Again I think that CTIX should do more to try out K with other chemo agents for various cancers and then to publicize these results- they have written/publicized very little in this regard, even though such trials going forward are the obvious next steps
What is up with K ending phase 1? When will we see K plus another drug?
Bologna now off the table.....awaiting K +/- other taxol family drug for ovarian- but when?
And Beth israel renal cell ca K plus a biologic- where is that at?
And pancreatic CA.....
Will we hear anything before June 1-3 and the next ASCO?
wow that is a lot of studies and will take a long time to get through. Started with the first article, which attempts to summarize therapies involving p53. It is quite helpful in that it includes all the citations, so you can look quickly at the studies involving apr-246, one of our main competitors, and ganetespib(sp?) and then HDAC drugs.
It is notable that nothing out there yet has worked well in later stage trials, and that is of course well-known and why we are invested here, in part.
It is disappointing that kevetrin gets no mention and that everything else under the sun(arsenic, etc) does get included as possible therapies
Will try more articles as time allows.
If anyone finds any of them especially interesting please speak up.
If CTIX can prove that K really works, it will be on the front page of every newspaper(duh)
well illustrated by CTIX price movement despite reasonable progression of science
Thanks once again to you for a gracious reading of the scientific papers that cause many of us to gnash our teeth or rend our garments. I very much appreciate your ability to clarify what is hard to grasp. The major point remains the complexity of the the p53 cancer story, and the likelihood that many drugs/approaches will be needed.
More on this point: I happened upon a friend's copy of Nature Chemical Biology. It has articles germane to both Kevetrin and Brilacidin(I think) Jan 2016 vol 12 no.1.
We have pondered, briefly, ReACp53, and now we get RITA. Page 22 leads us into 'CRISPR-cas9-based target validation for p53-reactivating model compounds'. A team from Germany describes their work to understand the precise targets of p53 drugs using CRISPR-cas9 technology. They focus on nutlin and on RITA, an acronym for a compound that works by"reactivation of p53 and induction of tumor cell apoptosis." Nutlin occupies the "deep hydrophobic cleft" of Mdm2 where it binds to p53 - and leads to its degradation. Whereas RITA binds the p53 N terminus. Both block Mdm2-p53 binding.
They show that nutlin inhibits cancer growth in a p53 dependent manner but RITA can block tumor growth by other mechanisms independent of p53.
Where does Kevetrin fit in all this? We have heard on many occasions how Kevetrin has multiple purported mechanisms of action in the wide world of p53- maybe CRISPR-cas9 will help clarify, I don't know.
And then on page 40 we come to Suzanne Walker of Harvard Med Dept Microbiology/Immunology writing with friends about "A Synthetic Lethal Approach for compound and target identification in Staph Aureus" I will admit that I am still struggling to figure out how this might apply to Brilacidin, but it probably does.
I will need to re-read several times and ask the more scientifically minded .
And finally, who does not find Buzz Lightyear and his pals amusing. It is ironic of course- I came up with my moniker to gently poke fun at the hard core posters who tolerate little in the way of dissent opinions of CTIX. Then I find myself fairly wildly enthusiastic, with reservations, about the prospects of this odd company in the Boston suburbs with a potential big time drug in oncology and a maybe big winner for gram positive infections(some gm- applications) not to mention the possible dermatologic force of Prurisol.
Feeling reflective I guess- I thought this would be a winner of a stock, and I still do, but never saw the price drop coming. When should a new investor bother to buy in, and when should older holders seek to average down? that is my lot, the quest to average down, at this point in time.
Re Kevetrin and p53 therapies: 12/31/15 article see online Cancer Cell lead author Eisenberg. They see aggregation of mutated p53 as one problem in cancer development. Specifically, working on ovarian CA they designed an agent to block p53 clumping, called ReACp53, that restores function of p53 in tumor cells.
They suggest it has some links to blocking clumping found in Alzheimer's and Parkinsons, for example.
Hard to know where it might be headed- certainly Kevetrin has a huge head start, and many more modes of action on p53.
It is just interesting to read about.
p21 data already spoken of in many PR's
yes will be helpful if they have anything new- but that will already be out in PR's to come before a paper- doubt strongly they would hold back positive news given current sorry share price
they have already stood up at ASCO and presented data about Kevetrin on a couple of occasions for their peers
Strongly doubt pahse 1 data will go in a high impact journal- UNLESS there is new compelling data
No high impact journal that would publish what we have been told so far- hey everybody, a drug acting on p53 has proven to be safe
The methods and materials have been out for many moons already
Cannot understand excitement over a Kevetrin article. It will likely have zero impact- unless it has new info in it. But the company will release new info when it has it, I think, and not wait on an article.
Press releases about efficacy -when those finally arrive- will either make or break the stock
thanks for summary
Pretty hard to understand- twice a week dosing for ovarian but considering a pump- how to put this together, continual dosing vs not so frequent dosing
New competitor: COTI-2. Novel small molecule(sound familiar) that restores p53 function starting phase 1 at MD Anderson- who knows when. For use in Li Fraumeni and other tumors, the usuaul suspects.
Oh yeah- an oral agent.
Way behind K in development of course, at this point.