Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Ladies and gents, nota bene: you heard it here first. Jay Bradner will take over from Mark Fishman for Novartis Biomedical research. He works at Harvard Med and at Dana Farber and his publishing record includes many articles on topics you might guess incl epigenetics for example.
You wanna guess if he has heard about Kevetrin? I would bet he has. He is walking around the halls of Dana Farber and has to know Dr Shapiro
I would expect Novartis to have a serious interest in CTIX/K, IF IT WORKS.
This has to be god news for us.
We shall see!
Sadly I know of no big announcements coming soon
So phase 3 B starts..expected, big whoop.
no news soon on B OM
I doubt anything on K for months
What will be real news that will move the share price?
Waiting for Godot....waiting for Bologna....what's the difference?
Don't you think there has to be a conclusion to phase 1 before Bologna moves forward? Or even the post phase 1 increased dosing regimen data? So they can choose the dosing?
Let's see- we need 3 and 6 month post treatment data for phase 1? And people are still enrolling. We will be lucky to get a report at ASCO 2016,
I am afraid, about phase 1 completion
Thanks for posting links.
Also of note:9/11/15 cell death and diff article on another p53 mechanism of action M Charni lead author
They show that p53 induces liver to produce proteins that are active in breast cancer cell growth or suppression
Also- a guy named Goy writes a bit in Onc Live DNA Damage repair, short article, again with p53 focus.
I had never heard of Lasker prize winner 2015 Evelyn Witkin who showed heritability of cells' surviving radiation damage felt due to p53(as far as I can tell, short mention, but it is interesting). She found this in the 1940's!
interesting article on p53 mutation in large numbers in Brazil and Paraguay. Can find by looking up Sue Armstrong Medical Express Set 15 . As prev noted I am no good at cut and paste.
Many thousands in Paraguay and several hundred thousand in Brazil - acc to article- have Li Fraumeni variant
I am still trying to post about any interesting science stuff like the triple negative breast cancer article from yest , and the mutant p53 epigenetic impact (histone unfolding) a coupla weeks back
Not to mention the following future pr's:
Next to last patient has completed enrollment in Kevetrin Phase 1 trial
Final patient completes enrollment in Kevetrin Phase 1 trial
CTIX announces a guess when the Bologna AML trial will begin: we announced it was starting soon about a year ago, so who knows really. We don't know- the country is just getting back from vacation and returning to work. So submit your guess and one day, sometime in the next year or two , maybe, we shall see. Guesses may be sumitted directly at Beverly office- we promise someone will be there to answer the door- it's not empty as some nefarious individuals suggest
Cellceutix announces possible upcoming discussions with FDA about Hidradenitis Suppurativa. Just wait until we know more about Brilacidin OM, even though earlier we were going to meet with them anyway. It is now on a back burner. But at least it's on a burner.
CTIX announces potential jackpot indication for ulcerative proctitis, but only once more is known about Brilacidin OM, which will take a long time. But maybe at some future point it will be a big winner for us and proctitis sufferers. Also on the back burner.
CTIX says the new gram negative drug 1807 might fit on the stove but burners are crowded.
CTIX says it will re-release previous old favorite PR's. Look we just re-released the Brilacidin hip joint materials announcement. Let us know what other your other favorites are and we will consider them for regifting. The disappearing spleen lesion? They're all on the table, get in line.
Review article on Triple Negative Breast Cancer, you can find online at Targeted Oncology, Evolving Paradigms in TNBC.
This is similar to the NEJM article about brain tumors, where there is an attempt to take existing knowledge about cancer pathology and morphology, and then to correlate with genetics. In other words, what mutations lead to what tumor types and how to individualize therapy.
They do not give percentages, just noting that TP53 plays a large role in these difficult to treat cancers, which are a smaller subset of all breast cancers(as you know). TNBC comprised of 18 subtypes (acc to article) with different genetic signatures.
When will all of this lead to better headlines for Kevetrin? Will it take 1 year, or 3, or 5? Currently my google news search for p53 and Cellceutix dredges up new law firm after new law firm looking into CTIX misrepresentations of its science, and little good news.
Looking forward to the day when we turn the corner and we start to hear about K in combo with X and Y and Z moving forward into all sorts of trials and all sorts of cancers.
For now, we are stuck in a dark dismal corner of the universe. PR's are about the final 3 patients being enrolled in phase 1. Does this mean we have to wait until this spring for phase 1 closure and release of data? Will it be pushed back to next ASCO? And when will we learn about the answer to the big question of whether Kevetrin actually works, now that we know it is safe? Hints from CEO have done nothing for the share price, that is for sure.
A bit more science:
ArcherDX- a company based in Boulder with manufacturing facility in, of all places, Beverly MA, has new ways to detect mutations in p53, supposedly easier than prev genetic testing
Also: in Nature, online, more info on p53 mutants as oncogenes. UPenn Med School(first author Zhu) gain of function p53 mutants modify epigenetic enzymes(MLL1, MLL2,MOZ) which then lead to histone methylation and acetylation, which then changes the shape of chromatin to lead to uncontrolled cell replication.
More attempts to clarify the role of p53 in cancer
I guess then that the cellceutix site needs to sign up for the email updates ? To stay in the game? I still think it makes sense that dosing not known from CTIX end to give Bologna the go ahead
I was reading from the company website, click on product pipeline, then kevetrin, then look under U of Bologna
I have been reading back over prior press releases and website info trying to find data about other tumors and Kevetrin. I was surprised to find in the 9/24/14 update PR that Kevetrin in early cohorts stabilized the CA 125 in some ovarian CA pts and stabilized the CEA in one pancreatic CA pt(NB usual pancreatic ca marker is CA-19-9)for 4 months. This was news to me, since there has been no info on CA 125 or CA 19-9 or CEA released in any press release- other than of course the mention of the disappearing spleen lesion patient having an increased CA 125 over course of treatment.
More recently we have heard about the CT scans stable for some ovarian CA pts at 3 and 6 months. And of course there is the thymoma pt. ASCO 2015 presentation says that this is a 48 yo man , patient 129, 8th cohort. Apparently he is stable and getting kevetrin for 11 months.
What does that tell us about other 8th cohort pts? How about patients 124 and 126 and 206, all with ovarian CA, and patients 130 and 131 with endometrial CA? Of course we know nothing for certain about them, how long they got Kevetrin, or whether biomarkers stabilized, or if they had CT scans that were stable. Some of these pts must have been the basis for the stable CT scan data and for the ovarian CA orphan drug application and approval.
One can surely say that the juicy morsels come from CTIX and that the Shapiro presentations do not give much away.
Also: I was surprised to read on the website that Bologna cannot start until more is known about the MTD from phase 1- just as thought- and it is the CTIX part that needs clarification, not a prolem on the Italian end.
CTIX haiku:
Small molecules
Kevetrin Brialacidin
They may change the world
Shares at 2.7
The purchase seemed a bargain.
But look now. Hindsight!
Wild type and mutant
Genome guardian 53
Life and death of cells.
Last year 9/28/14 he also said the trial(K, Phase 1) was in its late stages.
that is still true today, 11 months later
I still think delay has to do with ongoing K dosing issues. You could be right of course, the reason for the delay is elsewhere.
But I think-Somehow still dependent on these last few patients- and possibly even dependent on those next "up to 12" If CTIX confident of dosing choices why bother with the Dana Farber review board revisit for extra dosing. Why not just announce ovarian ca trial some pts getting 750 5 x week and others 1000 4 x week? And announce Bologna dosing?
I think they still have not decided. But i haven't a clue really, just guessing at the reason for the delay
why isn't the problem more along the lines of, what should the K dose be? Waiting for more Phase 1 info?
from the CEO's desk 9/28/ 14 on CTIX site
we are pleased yadda yadda expect the trial to start 4th quarter 2014
It was the usual expect the trial to start shortly
I found it when looking up AML kevetrin and it was a pr about a lot of stuff date was 9/14 ? 28th
can find exactly when off after midnight
Look back at Sept 2014 PR- U of B was supposed to start then
So it ain't starting any time soon, I would venture
And yes, I did write to CEO to ask for help in locating such studies, since he says they exist.
Combo treatment- any help? we have been talking about its importance for a while on the board.
Leo said in latest release that combo data is out for 1-renal 2-GBM 3 pancreatic 4 ovarian and 5 AML. The only problem is, that I cannot find any such data on the site, where he says it is, except for the mention that BIDMC did work with sunitinib and K (renal)and there was additional benefit. No hard data shown that I can see for renal and K, and NOTHING about any of the others, only the usual in vivo info for dug resistant tumors and K alone, in comparison with other agents, but not in combo.
As has been said, there is a lovely graph on the Aprea site showing benefit of cisplat + its drug for resistant ovarian ca.
there is nothing similar anywhere for K that I can find, even though he says its out there.
Any takers? Thanks for looking, I tried.
You may be right, but it is hard to say for sure. MRSA is all over the place and is now the most common cause of cellulitis seen in the emergency dept. It used to be picked up in hospitals especially, but is all around us now. By that I mean, was the MRSA on your skin when you were injured already? Or we, the hospital world, passed it on? It may well have been the ED
As for technique: this is a tricky business. As I have prev written, even Tom Brady, the NE Patriot's quarterback, got an MRSA infection from his knee surgery? Did the surgical team gown and glove and follow procedure? I would expect so. It is difficult.
Very nice personal perspective. I have tried to tell you about patients that I see in my emergency dept that would benefit from Brilacidin, versus standard available therapy. Your own story is instructive.
Should one be skeptical? Sure, why not. The phase 3 will help address the skepticism, and prove the worth of Brilacidin, or not.
Now wouldn't it be nice to know more study details?
Harry Potter and CTIX: I open at the close.(Read on)
So what is new re K? Before the recent attack, in April, CEO already said stuff NOT said at ASCO, that "some" tumors stabilized and that p21 increases were dose dependent. Truly new?
1- more specific info about stabilization on CT scans of ovarian CA pts at 3 and 6 months
2-one thymoma pt has been stable for 11 months
3-additional info about p21 and gyn malignancies
4-2/2 prostate ca pts increased p21
what we wanna know:
later cohort responses
new dosing regimens
publish the dose response data when you can
CEO says phase 1 near to a close.
For you Harry Potter fans who recall the phrase open at the close: I predict: as Phase 1 closes the very wide and spectacular possibilities of kevetrin will open:
K + cytarabine + sunitinb + cisplat + immunotherapy + radiation for all those cancers out there..
That is the future that I think we will see.
Will it come true? No one knows right now but all eyes are on the next bits of info. How much more will we know as phase 1 ends, vs next phases with more specific treatments and combo therapies?
I sense this is the real deal and have invested accordingly. K could also flop- that is still entirely possible. Leo cherrypicks early data that will tell a false tale in the end? Or, early data promising, the story unfolds?
That is the real drama here, as we all know, not the short term ups and downs.
I know nothing about the management stuff and do not have the time or inclination to get into it.
Sunspotter is not a friend, or esp an enemy, if he or she is a skeptic- fine by me.
As I said: my own view is more optimistic
The resistance question is not the make or break question with this antibiotic. Lack of resistance would be an unprecedented bonus - and I for one am skeptical too, re: how long resistance would take to develop-but it appears to be a better drug for MRSA and gm+ generally than anything else that I know of. Yes, this is based on a phase 2, sure.
You are a good skeptic, and it is easy to be skeptical.
If you wish to be nothing more than a skeptic that is a fine role on any board, or in any discussion in life. I welcome your thoughtful objections to the usual board discourse.
My own view is more optimistic. Sure, time will tell. But I think B and K look like good bets for now.
Do any of us really know? Of course not. CEO and Dr Menon do not know yet either. It is playing out in front of us, and here we have front row seats.
It is really something to watch, in my view This is not some run of the mill sideshow claptrap. It is the real deal.
dose dependent p21 increase also mentioned in April corporate update
I thought I was paying attention and I am not, apparently
Still waiting for details. Am I willing to wait for an appropriate venue?
re: sunspotter : some of the stuff put out recently was sheer desperation in the face of the attack. That might not be good practice, or how Dana Farber wants to do it, but I think he was doing anything to help
they should publish the data- how strong is it?
wrote to CEO again
So I cannot read. Sorry.
It is good news
Pls clarify: CTIX has never shown or said there is any dose dependent response in p21.
THAT would be new info
Why would I sell when I think in the long run there will be good news?
I am talking about short term woes
But I get your response- it is easier to tell people to sell than to have to think about current problems with CTIX
Timing is everything. Attack has come at a point when CTIX has nothing important to announce, apparently, or they would have done so.
In sum, we have heard that some patients stabilized at low doses of K(and some did not obv)and that was good. We heard about the thymoma patient and that was good.
But not good enough.
Exciting phase 3 B details.... New data on response to K.....Early B OM data...?
Please let there be light.
Leo wrote back that the many cancers in combo data is IN VIVO- nothing new to release, all older data
Therefore press release not helpful in my view
Need time to digest today's K update, doubt an impact. Again with the half have shown a more than 10% increase in p21. NOTHING about any dose response curve.
Look: CEO says many combo studies with other chemo agents incl ovarian etc
RELEASE some of that data already. Yes I sent the same message to the CEO
The stock is withering on the vine and that is it?
Point by point refutation of short attack article and yet here we are again high volume, tanking price?
Cannot help at all here out of my depth
Interested in conclusion that fixed dose might work, which would make it pretty easy to order
For those who live in / near Boston- there are lots of events for Dana Farber fund raising, such as the recent Pan Mass Bike Ride. Today and tomorrow one of the sports stations, 93.7 interviews cancer patients and caregivers all day as part of fundraising.
I recently put up a brief summary of a Cell article about Burkitt's Lymphoma and p53 and malaria infection, an attempt to explain B cells gone awry. it is not a common cancer in the US
I was surprised to hear someone describing(briefly) his case of Burkitt's and his treatment on the sports channel when I turned it on driving home from work.
Hypothesis is that loss of normal p53 function may be part of the tumor's origin.
My point would be, ye, it is rare, but what if a drug like Kevetrin would help.
You add up some thymomas and some Burkitt's and some whatevers and soon you are talking about real money. I mean this to sound optimistic not callous.
How could they know then what dose of K to use? When there is still no MTD?
the trial cannot move forward until there are decisions on K dosing. Will there be variable doses of K? varying times per week? We don't know
No Bologna till more known from phase 1 trial- that makes sense right?
Preferred your original response!