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1)I see and treat cancer patients every day as part of my job, and I will be as happy as anyone on the board IF Kevetrin is a real success- not just prolonging life for a month here and there.
2)I have the same personal involvement as many on the board with family members dying of a tumor with a p53 mutation, and again,it will be a happy day if Kevetrin works.
3)Hey, we have something in common, like most of the people on this board. I am just not able to see efficacy yet, unlike some who write mysterious statements about Leo and Shapiro and Dana Farber clinical staff aware that it works when we have no valid proof - as of now.
I appreciate your perspective but would expect nothing exciting-nothing-from an article or from ASCO 2106
my understanding was that he meant the other phase 2's- pancreatic, AL and renal- for the time being
I said at the time I did not know the reputation for Mayo as a cancer center
Then I read the web site and I looked through all 17 people listed under pancreatic cancer research, read their research backgrounds, looked up some of their papers , gave a brief synopsis to the board, and said I was thrilled with the affiliation
Sorry if that does not suit you-
Maybe you can let Leo know about these funds so he can proceed with the phase 2 trials he just unequivocally stated would have to be put on hold, on the back burner?
read my prev post
Every day and every hour massive amnts of time and money are spent on drugs that do not pan out
Kevetrin may well fail and Shapiro et al will still go on with their work to solve the cancer problem
It is just the way they do business
Do you really not get the fact that phase 2 and 3 drugs of great promise fail all the time?
your questions are not rhetorical. What is the scientific process- clinical trials- other than attempts to find drugs to cure cancer, many of which are doomed to failure, and some of which succeed? They move forward because they want to succeed, they want to save people.
But of course they do not have the answers yet. Why is that hard to grasp? DF and all the cancer centers and many companies, like CTIX, all spend millions of dollars and thousands of hours and sometimes they win and more often they lose.
Anyone who thinks otherwise about Kevetrin at this point is not paying attention
Those potential efficacy signals are intriguing, but add up to nothing now. The very little patient information is too little- hard to believe the board would believe otherwise. It is wishful thinking only to pretend it will really benefit patients versus standard comparison agents in a meaningful way- for now.
We all hope that ASCO 2017 or 2018 Shapiro will tell us that the phase 2 ovarian trial is being stopped early due to the benefit seen in the Kevetrin alone or the Kevetrin/ Docetaxel groups.
But potential efficacy? The emphasis is on potential, and there at least we agree.
Let's see. Leo just said what I quoted: that for now the only phase 2 he can fund is for ovarian CA. He plain came out and said that, right? Did I misquote him? No, it was word for word.
So what might that mean? It means that for the time being ovarian CA will be the only phase 2 trial funded, unless you believe he is disingenuous. Could funding materialize and things will change?
That is all I meant by sink or swim , for Kevetrin, and it is self evident.
Unless there is a change. Maybe we get the panceatic CA graant monet with Mayo and that trial moves forward. Maybe not.
they have been glad to share what they know is positive-(disappearing spleen, thymoma pt etc) so far as we mortal shareholders know
Too bad we do not all have access to the insiders that already know that Kevetrin works.
I wonder how well it works- those pesky trials- we just have to wait
What exactly do you suppose that they know and we do not? If there were convincing proof of efficacy CTIX would have broadcast the news far and wide, and it would be a major news story
But wait...maybe I should just look back through the press releases to find the one where Leo says that he and Shapiro already know that Kevetrin works. I'll start looking, OK?
We have been over this ad nauseum. There is no proof of efficacy now. Case closed.
Thanks for clarifying that efficacy is for phase 2, which we all await- we have only been over this about a million times.
Huh? I would never say it is a failed drug. Its efficacy is unknown.
I have high hopes for K and a lot of shares in this company.
But I do not know if K will be a winner or not.
Recent interview Leo : of course irresistible desire to read carefully for any hidden info.
Some stuff he says clearly: regarding other trials for K, besides ovarian - "additional trials will depend on funds that become available"
OK- no money now available for pancreatic(hence the grant application) and none for AML and none for renal CA
Fair enough- we sink or swim for now with the ovarian trial
who can possibly know what it means that "they have requested that we do certain scientific experiments" at DF with K and that "it's a real honor"
I suppose that it reflects some optimism of all concerned re K, but it is obscure for sure.
And then the UP debate- is he tipping his hand that Brilacidin OM is working? But it's a blinded trial- does he really know?
what they have been doing is the standard clinical trial approach to any new medication. They have now shown safety for a drug with a short half life given once weekly
Whether it will be safe when given at other doses is NOT known.
Nor is there any data on efficacy that is meaningful.
There is the thymoma pt who is doing well. There are some elevations in p21 in some pts. This is NOT efficacy
There is no convincing data on efficacy and of course this awaits phase 2
Promising drugs fail in phase 2's all the time and Kevetrin may fail as well
Because that is how trials are conducted. They do not know if there is any efficacy at this point in time, but they would like to find out
What you found suggests I remember it exactly wrong, and that they were interested in showing efficacy before moving forward.
Thanks for your information.
Iw ill look back too but this sure looks right
If so that is good news for us shareholders- and we can use good news
I can look through prev pr's but, again, my sense was that he was talking about how the Brilacidin OM was tolerated- but apparently I am exactly wrong- good news for us
not for nothing though- this is excellent news.
Cannot tell what he means by the K extension stuff. He does make it sound as though the researchers think there is something about K that is worth pursuing, above and beyond what you might expect from any trial. But who knows.
I think this is a hint ONLY to say that brilacidin OM is well tolerated by patients, and not that it works
Leo has said on several occasions that the ulcerative colitis of the rectum trial would move forward as long as Brilacidin OM was not having major problems
for comparison: re Kevetrin and phase 2 for ovarian ca apr-246 has a 1/2 trial with ascending dosing of their p53 drug apr-246(PiSARRO trial)
that is the only other drug I looked at so maybe very commonly done in phase 2 though they call their trial a 1/2
I know enough to ask questions about whether the company can assure us all that phase 2's are just around the corner when safety is not established at the possible dosing regimens they may propose. The FDA has not said yes to their phase 2 trials yet.
Until I started banging on this drum I read nothing about the topic here on the board.
as an investor i will be sad if we get a pr that says phase 2 trials will be delayed 18 months while Dana Farber conducts add on dose optimization studies.
But yes you are right we can all just wait and see..and not bother to wonder about anything at all. Just sort of sit here, quietly, and not pose even simple questions.
of course agree twice weekly given short half life not likely best dosing
They are going to have to keep at it to find optimal dosing.
I do not know how often the start of phase 2 trials involves working to find the best dosing(obv not a topic I know anything about without starting to read/ask)
uh ....yeah... of course, that is what we are talking about
the question is, how many doses weekly at what strength? Or even a pump regimen? Clearly, CTIX is saying the optimal doses for safety and efficacy are a work in progress- not a surprise
Will the FDA approve what CTIX/Dana Farber propose? Will they accept such a dosing optimization phase early on? Or will they ask for more optimization pre phase 2 trials?
Response from CEO is that optimization of dosing will be a part of phase 2, the early part.
So there you have it
So twice a week for a drug with a very short half life?
Is that the optimal dose? Likely not.
Maybe they will simply say we bet K will be safe at 4x week, or safe with a pump, and proceed.
But The risk is obvious if they fail to optimize dosing: toxicity that was not anticipated, or even worse, failure to demonstrate efficacy.
What if they do a phase 2 trial for ovarian that would show efficacy with 4-5 doses/week but no efficacy at 2x week?
That is why I thought they were doing the add on to phase 1- to get the dosing right
So I wrote again: How can Kevetrin move forward with phase 2 studies when safety with more frequent dosing has not been established?
For those of you with better access to Leo pls see if you can get an answer to this question.
Maybe the answer is, phase 2 studies start all of the time without precise knowledge of side effects at the doses used. If it is that simple, fine by me, still a concern for safety profile for Kevetrin
on 2 occasions. no answer
can try again
agree with you, and yet here we are, without enough data to establish SAFETY at the doses Dana Farber and Mayo et al will want to use. For those phase 2's.
As the board has stated ad nauseum, the purpose of Phase 1 is safety.
But we do not know if it will be safe at future doses(such as the drip you wrote about- just to take one example, not that a drip will be planned)
Sigh.
Can they really simply proceed without more data?
Re:your first sentence:
if we have not seen safety for more frequent or longer duration dosing established, then how can phase 1 be over and how can phase 2's begin?
Sure it is safe when given once a week.
But Dana Farber/ctix/we do not know about side effects at other dosing.
How common is it for trials to move forward into phase 2 trials when the actual doses to be used have never been tested prev? Is it done all the time?
Still wonder if they are going to have to back down on the stated move straight to phase 2 for K for ovarian, pancreatic, renal, AML
google news feed for p53 pulls up a discussion among hematologists trying to explain the cytogenetics of AML and response to treatment
They reference less than great response of bone marrow transplant in AML patients with p53 mutation
Another very picky example of trying to tease out treatment plans for cancer patients based on mutations underlying cancer.
Another example of why this stock might be a big winner.
On an unrelated note: I am still baffled at how the pharmacokinetics from once a week dosing of a short half life drug allow you to go straight to phase 2- but hey, what do I know?
Wil Mayo collaboration prove to be more helpful more than MD Anderson connection? Sounds like it from the press releases
Bring on the phase 2's. Prove you mean it, CTIX, when you say you need no more dosing data to start those trials
Retroelements? yet more new info about p53 and cancer. So complex- how many of you have heard of transposons and retroelements? I have not- but I am a genetics know nothing
Genes and Development article UT Southwestern study out about p53 role in growth suggests p53 mutation allow for cancer development by failing to regulate the development of "mobile elements" that disrupt chromosomes.
If you search MD Anderson and Kevetrin you come up with the materials agreement in 2013.
But after that? We have heard about retinoblastoma connected with MD Anderson.
But when I am on the web site for research at the MD Anderson center and I search for Kevetrin I get--- nothing. Will keep looking
Thanks for refs
Welsh article suggests role for checkpoint plus p53 drugs but the drug he and team are using - in the article -is MRX34. I wonder if they are also using Kevetrin? I write this without having searched
Thanks for your generous response about the dosing and agree that it will be a work in progress and of course we are all interested to see how this shakes out.
Agreed the Mayo collaboration much more impt than the orphan designation, and also that the grant itself is of no significance, win or lose, what matters is working with a team of dedicated pancreatic CA specialists who see a lots of patients and run a lot of trials.
Phase 2 ovarian, pancreatic, renal- we are about to learn if Kevetrin actually works!
is it possible for them to feel good about such dosing with respect to side effects based on what has been done so far, the once a week for such short half life drug?
Related question: how can a pharm PhD determine dosing- move to a pump, vs 3x a week at 750, or 5x a week at 500 vs other? Is it not that hard to decide?
I am sure you agree how great it is to see them involve another major cancer center. Check out CTIX and Mayo!
Wave- thank you for the excellent answer to all my recent worries. Leo clearly states no influence on phase 2's for the additional patients for phase 1 extension- no delay for that reason
The big question then, is why bother with it?
In order to maybe show efficacy in a broad range of tumors? To help with other future dosing decisions?
This is the best news I have seen in a while and it was right in front of me.
Let's hope they follow through with this time frame.
I missed that(obv)- can you tell me where it's written-thanks
Of course you are right- it could start.
The question is, will it? Or, will they wait for the additional info from the phase 1 extension?
My guess(just a guess) is yes, it'll wait - otherwise, why have this extension at all?
We would all love for them to jump into phase 2s. But why no phase 2 for renal ca at BI yet, with sunitinb?
Why no announcement of starting a phase 2 with ovarian?
Methinks they await dosing decisions based on the next rounds of patients from Dana Farber.
Would love to be wrong and the the phase 2s start!
As you said, we have forgotten it(not really, I have written about it a lot, BI of course one of the big Boston hospitals)because they announced it so long ago and then we have heard no more.
It is a LONG discussion between BI renal CA people and Beverly.
But what is to be expected so early on?