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No - I mean in COMBO not stand alone. I meant what I said. K will be used in combo, as you and I have already discussed, though you may see o/w. And I was just trying to list a few of the potential combination therapies where we may see trials in the near future.
We already glimpse the future with AML (plus cytarabine) and renal cell ca(plus sunitinib) What I am saying is the most straightforward stuff in the world....
The world of cancer therapy need not wait for Bologna results, and it will not wait. K moving forward on many fronts simply awaits dosing decisions- so difficult because so far so well tolerated. Once there have been some more regimens for dosing, then we will see things unfold- BIDMC starts moving with sunitinib for renal cancer, then who knows what else. That is why I have been perseverating about preclinical studies for other tumors. Show the world what K looks like with mouse graft tumors for ovarian ca with cisplat, or how it looks for pancreatic CA with gemcitabine, or for small cell lung ca, or melanoma, or glioblastoma plus whatever other agent and let's get on board.
They have said there is efficacy with sunitinib for renal cell ca- I have never seen the data. Let's see some more data and start to line up K plus x and y and z...as long as it has some benefits.
Thanks for gumshoe updates from many people. I think the newsletter writer simply fails to get the potential of Brilacidin. Even if everything else fails, then Brilacidin, in all its current manifestations, will be worth much more than current share price.
Can anyone here summarize the gumshoe argument? Could not view it.
Why is it that the talk we most want to hear- or at least I most want to hear is not available? Gm- talk still not available...
Now that is funny! The profile you posted is quite the read. All true, or all made up, it is funny.
I contacted the DF trial contact person Mr Wolanski 2 d ago, as a personal matter( my sister in law has met panc ca) and as a shareholder and he said there was no p53 requirement.
your points are valid , and yet, when all is said and done my guess is that more than 50% will have the deletion.
I do not believe the final participants are only a coin toss for p53
And maybe we will get this info one day, and maybe we won't
sorry- I know what I wrote is the most obvious thing in the world but I thought I should respond
the clear reason it would deviate would be in favor of more pts with deletion, as you and your oncologist contemplate what to do next in a desperate situation. You would certainly be more likely to pick the K trial if you had the deletion-if you had the genetic info.
otherwise, there are a lot of trials, and you might pick something else
But hey, they said some, so that is more than one.
If they all had p53 deletions, I hate to say it, but I would like to see more. But that's just me, maybe.
One will not be enough for me, to be clear about it.
I suppose it depends on what you call "fantastic." Does it mean that K is really well tolerated? So much so that there is no MTD yet?
That is fantastic, BUT we already know that, and will only hear it again at ASCO.
How about the corporate update phrase some pts had stabilization of tumors? What is fanatastic here? 2 of 6 pts at 350/450? 5 of 6, with changes in biomarkers too?
That info we will find out shortly.
How many of the pts even had p53 deletions, where more benefit would be expected? We do not know this either, but will prob learn that also. One expects most of the pts would have such a deletion, or else why not pick another trial.
What about p21- we know it'll go up in later cohorts- they just said so- but we will get this info too. We don't know by how much. I would say the clinical data is more relevant.
My guess is that the ASCO presentation will leave us waiting for the next round of trials with new dosing regimens to get more info.
Continued watchful waiting.
Pretty funny I emailed him to ask about the gm-talk too, and he wrote back the same. How does he find the time?
You would expect that to be the case, since it makes sense for those pts to try K. Thanks.
This deserved a reply, as did your critique of my critique of corporate update. (Off last week, little time to write)
I am surprised that they are not recruiting only those with p53 deletions. It does make any conclusions about efficacy very difficult now.
I still believe CTIX knows if the pts have p53 deletions or not, and that the company would shout from the rooftops if they could about early efficacy, but time will tell.
New dosing, new cohorts, new data, all in the works....
Still wish for preclinical data about K plus other combo treatments-ovarian lung brain breast etc
Can you give a drug for an indication that it has not been approved for, is your question? If B approved for cellulitis, how can you give it for pneumonia?
MRSA is MRSA and if you have a great drug then it will be used. There may be more trials for pneumonia treatment, but the data are right there staring at you saying give it.
That is, when it is available.
Vancomycin is really only easy to give in one group of pts- dialysis/renal failure pts. They do not clear the drug so single dose often all that is needed.
Let's look at another classic pt I had yest: she had poor renal function and an ugly knee infection- old and frail. She got a dose of vancomycin 2 days before I saw her and I had to check a Vancomycin level before I knew if she needed another dose, or how much to give.
She has to come back to the ED and sit around for a long time because ED was swamped and then get a Vanco level (took over an hour to get test result....)and then get the drug- very slow to go in to avoid "red man syndrome" bright red flushing of the skin if too fast administration of Vancomycin- a common occurrence. That is a lot of time to lose to get your infection treated. She was here for 7 hours...
yet another candidate for Brilacidin!
I think that any extra bit of antimicrobial activity is helpful, and I have looked at the gm- coverage for Brilacidin a month or 2 back. It does well against EColi, but not so well against others, as I recall. And yes, that is why it is not mentioned, in part. BUT, also: they do not have to talk about gm- at all with B for the trials because for most patients with cellulitis and abscesses because those problems are caused by gm+ bugs. Just look at the isolates of bacteria for the phase 2 data.
Who gets gm- cellulitis/abscess? Almost no one- IV drug users sometimes, and diabetics sometimes.
The company mentions diabetic foot infections, and I wonder if they intend Brilacidin for this as well, but typically anaerobic coverage is also required, plus some gm- too.
What I find fascinating about the whole thing is the other indications for using Brilacidin, if they pan out. Immunomodulator activity. The mucositis data looks pretty good, right? And wouldn't we like to know what they have to show the FDA about ulcerative colitis? That is a BIG market, esp if they can expand it to all of the colon and not just the last bit of it. Really interesting stuff.
Of course I was referring to what you or I learned from the talks, and not what someone who knew nothing about any of it might learn
one response to your question, and welcome others .
How to get at this depending on your background? Much has already been posted on the board.
The answer depends a lot on what you know and when you know it.
To start: someone feels ill, usu develops a fever as evidence of infection, and toughs it out at home, or ends up seeing doctor somewhere. Initial question is- does the person have an infection, or an adverse drug reaction, or fever related to a tumor, an inflammatory condition(lupus, for example). Sometimes this is easy and sometimes not.
Let's say it is decided that this pt(patient) has an infectious cause of a fever. Then what is the source? Maybe easy to tell- bad cough as a symptom, or diarrhea, or skin infection/cellulitis/abscess. Maybe not so easy- nothing tells you the source of infection and you have to work and search and ponder.
Who is the pt? Immunosuppressed on steroids or chemo or immune therapy(rheumatoid arthritis etc)
Diabetic? Elderly? It goes on and on, but comes down to how much you need to worry about any given pt- do they fit into categories where they are likely to do well, or likely to get into trouble.
If you know the source of infection then you target your therapy to most likely causes. Not so sick pt with a cough and runny nose most likely viral- wait it out, symptomatic treatment(Acetominophen, cough med etc). But take a sicker pt- older diabetic smoker with decreased oxygen level, high temperature with a cough, and the x ray shows pneumonia.You are left to choose an antibiotic based on the most likely pathogens, and there is a lot of data about pathogens, and there are consensus recommendations about treatment of pneumonia for outpatients, for inpatients(those needing hospitalization), inpts who came from facilities with likely resistant bugs, and for inpts on ventilators, etc. Current recommendations say to always treat for Strep pneumonia and then to add treatment for MRSA sometimes, double cover for PsA(Pseudomonas) sometimes, cover for Legionella, etc.
In other words it depends on who the pt is and how sick they are and what the source of infection is. if it is diverticulitis you cover for gm- and for anaerobes especially, similar for cholecystitis(gall bladder/gallstone blockage). Or for cellulitis must cover for Staph and Strep. And on it goes, with many guides out there to tell you most likely pathogen for any given infection-UTI, sore throat, meningitis....
Once you have defined the infection- grown the bug in the lab-you will have the data on sensitivity and know exactly what drug will work and what will not. But this takes time and very often you never know. You treat based on probabilities.
So for a sick pt with a known source you cover with antibiotics for likely bacterial sources until you know the exact bug, and then you narrow coverage.
Or you do not know a source, you just know someone is quite ill with a fever, and blood pressure is low, and the stakes are quite high, and your loved one is in danger. Then you cover broadly. You give multiple big gun drugs to try to cover all the bad bases.
A good gm- drug would kill the most likely pathogens for any given pt, then, until or if you ever know exactly what the bacterial infection is actually caused by. Broad gm- coverage includes EColi, and Klebsiella and PsA as examples and that is why the charts always tell you how well the drugs do against these bacteria. Because PsA is a feared pathogen and a real killer ,it tends to be covered at the start for many types of febrile illness, until you can narrow things down. It is not always a likely pathogen, though, for example, in diverticulitis, or other GI problems,or UTI, less likely to be a problem.
To switch to gm+:
This is why Brilacidin is such a beauty. A sick person who develops pneumonia while in the hospital (or at a nursing center or rehab center) may well have MRSA and must have MRSA coverage when admitted. The hospital team will absolutely give a drug for MRSA in those situations and Brilacidin looks to be much nicer than Vancomycin, the usual go to drug. It would be given right away( increased sales) while also saving lives.
A gm- drug with broader coverage, including PsA, would be given more frequently, up front, when gm- coverage indicated by likely source of infection. This does not mean a drug has to cover everything gm-, not any any means, to be successful. But a better broader drug would be given much more frequently while attempting to narrow down antibiotic coverage, by determining the source of infection and exact bacterial source if possible.
That is a start of an explanation, anyway.
Agreed that Hancock talk is worth a listen.
Loved the antibiotic abacus chart.
The gm- talk still listed as of 10 seconds ago as not available because presenter/author did not grant permission. Wrote to CTIX to make it available.
The other two talks were mostly rehashing of already known info. The gm- talk had the most new info
Still trying to find a way to listen to the gm- talk- should be worthwhile for sure
No. 2020 is for earliest gm- to market.
Somehow thread has gone awry- we'll leave it
Oh- I did not mean hitting the market by then. I meant them even FINDING one to present on a poster similar to CC1807, as an over under. Market one? 2020 at very very best
After B will not be on the market for a long time even.
Look for fun we can make it an over / under. What shall we say? One year, the clock starts now? I would say over, for sure. Prob over for 2 years too
I will listen with interest. We shall see.
My guess would be the opposite- a long time or never. Polymedix was screening drugs for years and if the currrent candidates do not have broader gm- coverage it is for a very good reason- it ain't easy
Thanks for summary, esp BP stuff. Wonder how to listen to the gm-talk
tweaking...who knows how many years that will take.
agreed. what I said.
Final poster, what's new? Brilacidin info strong as expected
Re: adverse events. 17% increased SBP to more than 160 for the .8 dosing. I wonder what the starting pressures were?
I doubt this will prove any problem.
sorry- just do not know the answer without a lot of looking up. There are drug combos for sure. Not many examples from antibiotics that I know of. First that comes to mind is old drugs, erythromycin and sulfa, put together as pediazole, usu for kids.
There is constant use of antibiotics together- pick most illnesses. Let's just say meningitis, since I had a bad case recently. You use Cetriaxone esp for Meningococcus and Strep and Vanco for resistant Strep and just in case Staph Aureus and sometimes even Ampicillin for Listeria. Until you know what the bug is, and then you focus your therapy. BTW these choices are for an average adult, and might change depending on the patient.
But the approval process for putting together a couple of HDPs I don't know a thing about
Excellent post. It sounds more like a threesome found on a golf course rather than directors for a potentially big-time company.
Brief reprise of you say proctitis, I say colitis. Hey guess what: in the corporate update colitis now appears right beside proctitis in the header announcing B for UC. In the section proctosigmoiditis is described as a form of ulcerative colitis. CTIX joins the mainstream....
1400, since you are keeping track of my gaffes you can score this one for me
I will say again that there is much to like about the data from the Gm- poster.
I suppose it is all about expectations. I will admit that my hopes were very high, maybe too high, for this presentation. I was hoping for the gm- equivalent of Brilacidin, and no such drug was unveiled. B has such blockbuster potential, and I say this as a shareholder and a clinician.
I do not think one drug has to rule them all-CRE , Acinetobacter, Pseudomonas, etc. I do not think that is reasonable, and that was never my expectation.
As a shareholder I want a drug that would be front line, big sales. Having a CRE drug is wonderful but those infections are rare and the value of such a drug is less than the value of a drug that covers Pseudomonas, if you had to pick
You mention Invanz as an example of a drug that is good for gm- but not active against Pseudomonas. What I am sure you know, and I know, is how critical the anaerobic coverage is for that drug in its use. The board will not know this at all, and that is important to understand its value added for Ertapenem(Invanz). I have not seen data for 1807 etc for anaerobes. (Also Ertapenem has quirks like good drug for bad cat and dog bite infections(Pasteurella)
I did not say it was not a good drug. It is(if it works in people). But the Pseudomonas issue is real, not made up.
Look- the positive data are there for all to read. Should I just repeat them,like Biodoc, or can any of you actually read? Is it a post when you simply repeat what the slides say?
I wanted to add some perspective that you may not have. Others who actually treat patients feel free to chime in
When you cover gm - bugs you cover broadly to start, and you MUST cover Pseudomonas.
That does not mean that you cannot call in 1807 for your resistant Klebsiella superbug, but it does mean that it'll be more of a niche drug- based on what they have said.
How often do you hear discussions of the need to cover for Pseudomonas, or the need for double coverage for Pseudomonas? In a hospital setting it comes up constantly and it will be a real problem for 1807. That is why they took the trouble to talk about modifying the drug.
Sigh. Why do YOU think the speaker said that Pseudomanas coverage was a problem, then?