Agree with you that primary outcome now for K is MTD and safety.

But if the company has press releases about p21 levels and about patient success stories, then I think that more is at stake, even so early on.

Forgetting about the real outcomes: if CTIX says p21 steadily up as dosing of K goes up- as we expected- and says that patients in later cohorts continue to have disappearing metastatic lesions, the share price will rise.

And it will fall if they say the opposite, even as safety and MTD are set. Even though B looks great.

The long run is another story of course.

I apologize if I am looking through posts too quickly-

You are right.
I did not get the gist of you post, and I read through it too quickly. I agree with what you said.

Was it Steve martin who would say, Well EXCUSE me?

CTIX calls K an anti-cancer drug candidate on its home page.


I was speaking in broad terms- you approach cancer treatment by drugs, or radiation, or surgery, etc. Drug treatment usually goes by the broad term chemotherapy

I will try to say "anti-cancer drug" therapy if that is ok with you

Sigh

De-risked? I realize you all believe otherwise BUT:

what if the recent cohorts do not show a rise in p21? what if recent cohort pts do not improve much? This will mean that more trials will go forward, once an MTD is established, but announcement by CTIX of such results would certainly hurt the share price . IMO. That is why I have not bought any shares yet.

If human response parallels mouse, then I will have missed out on a lot of money. shares will be way higher with truly positive news. But it is not yet written in stone.So far they have talked about one pt with widespread ovarian ca who was getting better with respect to CT scan spleen findings and ascites- but dropped out anyway. There needs to be more data.

When the positive data comes out after phase 1( and phase 2 )you can scoff at latecomers to CTIX, such as me, and you will be proven correct. I hope the results are good too.

I was writing specifically in response to the CRE bacteria so much in the news.

Is MRSA a superbug that Brilacidin trounces? So it appears. But that was not the topic.
The issue is how much Gm - coverage B has.

Thanks. It is a slow night here in the emergency dept(3 degrees in my Boston suburb) and I end up with time.

Just to be sure I looked up Daptomycin and its target of action is absent from Gm - bacteria- so NO possible activity. Clearly an advantage for Brilacidin, though its scope of Gm - activity is still not clear to me

On this board there have been many comments about the superbugs and CTIX in the last several days. In the nicest way possible I simply wanted to point out that Brilacidin - so far as I know- would not kill those bacteria. This of course does not apply to what CTIX might have up its sleeve at Fox Chase etc- but these drugs are a long way out. Is that leading, or loaded?

i see that Klebsiella is also mentioned in a Polymedix article, in addition to E Coli. This in and of itself is sensational. Daptomycin and Vancomycin would have NO gm - activity for example.

How is this relevant? let's take a common scenario- an IV drug user shows up in the Emergency Dept with an abscess. Usu they have a gm + source, but IV drug users can have unusual gm - too. One drug to get both? That is excellent, extraordinary.

You are free to doubt my motives, which are actually quite simple: at what point is CTIX ok to buy into? Even if Brilacidin is great, disappointing trial results with Kevetrin would have to lower share price. At the point when Kevetrin proves its worth in trials, or maybe even with good results in the next cohort or two, all those who have locked in shares will be big winners, and I will be struggling to get shares at a much higher price.

My other motive in watching this company is simple: these drugs would really benefit a lot of people. Since when does one small company have a potentially revolutionary antibiotic platform and a revolutionary chemo agent? From a clinical standpoint, a drug like Brilacidin would make the job of every physician easier(No I am not a pretend MD. I actually went to medical school and have practiced medicine for more than 20 years). And as I said prev, my sister in law has metastatic pancreatic CA, and Kevetrin might save some of those pts in the future.

I have searched some to find out about the gm negative scope of Brilacidin and can find only a bit so far. One article mentions E Coli, which of course would be excellent. So far can find nothing relevant to this particular superbug(CRE).

I too await the Fox Chase data.

Carbapenem resistant bugs(Enterobacter)in the news recently are gm negative. Brilacidin likely has little or no activity against this bug, and the other CTIX drugs that might be relevant are far far away from clinical use.

Looking for adverse effects info from latest trial 2b, but cannot find. Saw the high rate of paresthesias mentioned in prev Polymedix trial, but not enough to cause stopping treatment. Lower doses meant less paresthesias in that trial; would be nice to know the date for more recent trial. Looking through the slideshow for the Jan 2015 I do not see this. Maybe coming out in Denmark. I suppose fast track status would not be granted if adverse effect profile was a problem.

Agree that B, at this point, is best bet for success. I did read the other ED doc review that you mentioned and of course he has good things to say about the gm positive and potential gm negative drugs with the caveat being as always, will they work without major side effects? Will the poster show new relevant data with gm negatives in Denmark? or rehash old data? So far from real use for gm - drugs. But yes, B looks good.

helpful thread about mucositis- data for B-OM looks better: but how long to wait for real value added to CTIX?

I agree with you that K is risky at this juncture and that your cautiously optimistic stance is the only one that makes any sense. Wouldn't it be nice to have more data about recent cohorts?

As I am sure you have been told many times your posts are worthwhile

Good info.

The other drugs do appear to have VERY long half lives. That might be helpful intreating infections like osteomyelitis or endocarditis where long treatment regimens are the norm- but less helpful in a typical cellulitis patient.

Very helpful, 10 points for Gryffindor.

Spoiler alert: sentiment expressed is caution rather than extreme optimism!

I reference here a wonderful post #91106, by the intrepid sclimmuno, in which he lists details about two drugs already approved, Dalbavancin, and Ortanavancin. Both are Brilacidin competitors, as you know, for skin infections. The first drug requires 2 iv doses, and the second one, only one IV dose. as compared to multi day Vancomycin treatment. Brilacidin did very well against Daptomycin, and offers the benefit of a one time dose. But one of the drugs referenced is also a single dose. Will a large company bide its time and let brilacidin prove it can beat those other already approved drugs? Or will they buy in ahead of time on the chance that Brilacidin will be better? There is no proof yet that Brilacidin can beat those other drugs that I know of- perhaps others have more info.

And Kevetrin:again,a couple of years away from proving its benefit in head to head trials. Human dosing still being worked out. IF the later cohorts show positive results there will be dramatic interest in this stock- but that has not been demonstrated in actual patients yet. This is a company that will not be shy to trumpet success- note PR released previously about a single patient, the one with ovarian CA. More PR from later cohorts will be needed to prove K really something special, and then of course, will need actual trial data to prove benefits.

In other words planning to retire at a share price of $30 or higher for CTIX is rather optimistic- at this point in time.

it is as you say- pancreatic ca is a tough cancer because often spread at time of presentation so inital surgery frequently never an option

Having just been out shovelling yet again- 4th snowfall on 3 weeks, more than 7 feet total- it must have thrown things off. Esp depending on where the patients live, exactly, and how hard it is for them to get around. But I agree with other poster that impact not huge.

Interesting reading. Many posts suggest the previous research and previous trials in mice etc guarantee success for Kevetrin. Somewhere there is a good summary article that details all the various stages where once very promising drugs failed, but I cannot see taking the time to find it because I thought it to be common knowledge. Of course the drug can still fail.

Now though is an exciting time to be watching CTIX since things are picking up : setting doses and actually enrolling patients then seeing if K really helps cancer pts.

Plenty of anti physician sentiment out there, unsure why. I would assume that I am neither smarter nor dumber than all of you, and I would never suggest otherwise. At this stage in my life(57) I find that I am enamored less of smarts and more of effort, and hard work.

At some point I hope to be of some value to the board, based on seeing patients most days with celllulitis, and I will be able to tell you the buzz on Brilacidin, and whether the Infectious Disease consultant is sticking with Vancomycin and why, etc. And I would hope to see patients in the ED on K, such as the woman I saw yest with ovarian CA, widely metastatic, and struggling.

My questions are if Kevetrin will turn out to be a wonderful new chemo treatment, or not.
You are of course welcome to ignore anyone simply thinking through the issues.

I guess it would be better if I posted "to infinity and beyond" without bothering to wonder if Kevetrin will actually do well in meaningful trials, or how much market share Brilacidin and Prurisol might win.

I chose p53 without a thought, in a second, because I was reading about it and its role in cell life cycle. I would have better better advised to choose the great slogan of Buzz Lightyear if I really wanted to fit in on this board. maybe I can still change: To infinity and beyond! On second thought, someone on this board probably already has that alias....

Just had a chance to listen to the presentation you cited, and it is informative. The pt may have been better off with Kevetrin- we just don't know.

Today in the ED I saw a pt with metastatic ovarian CA, and had a chance to ask the oncologist at my hospital who agrees that the CA 125 inreasing usu means increased tumor burden.

He did not have to look it up on Wikipedia.

BUT is 10% a real increase? And he also said the numbers can bump around a bit.
All of us wish we knew more about the 3 dozen or so pts, and how they have done, but especially important are the current doses if this is where Menon etc hope to see real impact

Would he push for NASDAQ if data are not good? Or does he believe it does not matter, and Brilacidin is enough to move forward with(plus waiting in the wings stuff)?

Thank you for mentioning the tape. One hopes that K might make a difference in the lives of many cancer patients.

Having read through posts on the CTIX board I find some helpful info about Brilacidin, but that is about it.

The Kevetrin discussion has a giddy quality, which is possible now, and previously, because the drug has only potential, and nothing more. Do you think that Menon, who has seen many a failed clinical trial, would dismmiss those who advise caution? Of course not. He is well aware the drug may never make it to market.

Pander to the board? As if.

Also: I brought up bashing only because I was targeted as one for asking the simplest of questions about CTIX products.

Of course other things can elevate ca 125

That is not what we are talking about!

Instead we are discussing a patient with a known malignancy who has a track record of Ca 125 tests, no doubt many of them, with a rising ca 125 despite Kevetrin. Why did the levels even get mentioned in the article? So that a fair picture is painted.

I am not saying it is a bad drug. No one even knows how well it will even work yet! I am just injecting a note of caution.

For a drug whose dosing has yet to be determined- let alone proving that the drug actually works in a real clinical trial- caution is essential. Dr Menon, who has no doubt seen MANY promising drugs fail in clinical trials, would tell you the same.

I have explained who I am and why I started reading up on CTIX. I am neither a basher nor a short. I am just as interested in you as seeing the clinical trial results, and agree that the stock has amazing potential. I would think there would be more tolerance of other opinions.

Any oncologists that would care to speak up here?

About this patient: prob followed for a while at Dana Farber- but of course I do not know this for sure. Therefore likely many checks of her CA-125 level, so there would have been some track record.

Let's ask the first 3 oncologists to respond- in widely metastatic ovarian cancer, in a patient with previously followed CA 125 levels, what is the most likely cause of a rise in biomarker? (Assuming no radiation- I think the article would have mentioned that)

I will ask people here at work the same thing.

Glad to admit ignorance if they think otherwise.

I would be more than happy to hear how I am missing the boat. My "valuation" was not meant to be precise, just a rough approximation of shares x price.

Research suggesting things are promising are only that- plenty of promising drugs fail all the time in clinical trials .As you all know.

CA125 going up when treated usually means the tumor burden increases- ask any oncologist. Does it always mean it, every single time? I doubt it. Nothing is absolute. Generally speaking it is bad news. My guess is that the information was included in the article because the company wanted to be up front, which is good.

The oncologists on the board can step in here, anytime.

As for B and P: as I said I find it hard to know how much more than $500 million they will be worth, and the stock already has a high valuation. For those who feel that billions in revenue are already in the bag with those 2 drugs, you may be right.

CTIX has the very high valuation for good reasons-if things pan out early investors stand to do very well.

Caution required on Kevetrin certainly. At this point just searching for correct dosing,with hope to go on, some science, but mostly hopes. It is still so early.

Let's take the last published report about the vanishing spleen lesion. Lower in the article it says the patient's CA125(tumor marker) continued to rise, suggesting that change in ascites and spleen lesion was telling only part of the story.

Many here are gambling that there will be a payoff, and the stock has risen for quite a while.It is surely a gamble though.

Take away Kevetrin and how much will B and Prurisol be worth? Hard to be sure.

Having read a bit more a big question is whether increasing the MTD will in fact increase p21 levels. The company clearly sees this as a measure of success, and the initial info- 50% of patients with a 10% increase-is not great.

Knowing the next set of numbers is critical- if the trend is for increasing p21 with increasing MTD, as expected, calling it good news would be an understatement.

Look: coming across a stock OTC that might have a startling new drug for many types of cancer AND a number of revolutionary antibiotics, it seems too good to be true, really. And yet the more I read CTIX appears to be the real deal. Time will tell.

Sam.

Tom- I edited my post and you are responding to the early edition.

Those who immediately called me out on Daptomycin vs Brilacidin are exactly right. I thought the longer Brilacidin dosing was necessary and was comparing it to a longer Daptomycin regimen. I read it wrong.

As someone who sees - and admits to hospitals- patients with cellulitis very frequently I think a one time dosing is almost too good to be true. But the results from the trial look convincing.

Sam.

Hello again.
Don't mind getting off to a bad start- I expected it. I am just here to learn about the stock, and it takes some effort.

OK: I work in emergency departments where we see many many skin infections OF course there is an advantage of one time treatment. I read the trial results wrong- the higher one day dose beats(barely) the 7 days Daptomycin- and I agree with you, that is a game changer. We physicians would have to get out of the habit of admitting many patients with skin infections, since you could confidently expect them to get better. My mistake.

Of course my profile was created today- I asked on Yahoo if anyone knew where there was more discussion about CTIX and this site was suggested, just this afternoon. I follow no other stocks here and own few stocks individually. I just found out about the company a couple of days ago. I was not working today, and in between doing shoveling outside due to these repeated snowstorms in the Northeast, I thought I might learn more about this potential investment.

I live in the Boston area, and have worked at the Brigham- sister hospital to Dana Farber, where some of the trials are, as you all know- many moons ago.

I am not a sophisticated investor or p53 expert. However, I am able and willing to learn, and that is how and why I ended up here. Yes I read some of the Seeking Alpha stuff and I understand there is a general skepticism of bashers, but that ain't me.

Just trying to get up to speed.

Sam

Greetings. Uncertain of the level of knowledge here-all I can claim is a desire to learn more about the stock and p53 therapeutics generally. This is based on general interest as a physician and an investor, and a personal interest- my wife's sister has pancreatic CA, a potential p53 target tumor based on her genetic analysis. Came across CTIX and found some stuff on Yahoo and was directed here and will start learning.

Just for starters- Why did you choose CTIX to invest in? How to know if this company really has something special, or if other p53 efforts are better? A quick internet search turns up Aprea in Scandinavia, also in trials, one with AML staring and one with ovarian CA. I need to try to look through the science to understand whether it might be better or not. Aprea is a private company.

Brilacidin- won't it lose out as Daptomycin becomes generic and gets a price cut advantage? Trial suggests slightly better, not loads better, than Daptomycin.

Thanks for any thoughts. I will of course try to catch up on my own, though I wonder about how much some of you may alrey know about these issues.

Sam