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12/15 first shareholder meeting. What possible value in attending, even though I live less than an hour away? Any chance any important question would be answered? I doubt it.
Maybe we could get hats?
I would imagine, if I had psoriasis, bad enough to qualify for one of the IV biologics, I would be thrilled to try a pill and not lose the time to go get an infusion, even though it is infrequent. There must be lots of patients who will want to give it a try- if it works
The Guardian Friday Nov 20; short piece about antibiotic resistance by a scientist Richard James, who says he was very pessimistic about the the threat of resistance until attending a conference in China about bacteriocins and future antibiotics. By bacteriocin he means bacterial proteins that kill other bacteria, so I am guessing he is referring to peptides like Brilacidin and other HDPs- he uses different words.
Now here we have a drug with a new mode of action ready to enter phase 3.
Now would be the time to see article in the New York Times or NEJM about Brilacidin and its development!
Eventually the story will break, before after during phase 3. I am sure we all expect phase 3 to succeed, but it is a long wait.
Starting to see more about the competition- Oritavancin ads now appearing in various forums(journals, etc) for MDs
Future Brilacidin patient vignette: Oh yeah- enough already?
A 70 yo man who has lost multiple toes already(though not diabetic) with recent MRSA osteomyelitis of his left foot/toes. Comes to ED with red and painful left foot, spreading up his leg.
I do not know his actual allergy to Vancomycin but listed as an allergy and recently treated with both Daptomycin and linezolid-last about 10 days ago.
Otherwise in pretty good shape- not horribly ill with low blood pressure etc
Here is a guy that you could just line up for Brilacidin and let go home with visiting nurse and MD followup, rather than readmit/IV Daptomycin, which is what we did.
Phase 3 bring it on.
Please.
A bit of reading about ovarian ca. My knowledge of this is restricted to reading- I do not pretend to know the ins and outs of decisions about chemo, but I looked over the UP to Date (most commmonly used source of info for MDs)article about platinum resistant treatment options .
In short, there are a lot of options and nothing has any great efficacy. The recommendations are for paclitaxel, and doxorubicin, and others, incl gemcitabine. Also if BRCA + then olaparib. Other therapies mentioned are an angiogennesis -umab(long to write out), hormonal therapies(letrozole etc)
Docetaxel is mentioned, along with its significant toxicites, esp hematologic and nausea and vomiting(of course dose related).
Presumably CTIX tested K with all of these drugs and came up with docetaxel as most efficacious? Much is made of side effects in terms of choice of agent as next drug, for example, in the discussion of PLD(Doxorubicin)- given infrequently, few side effects etc. Would be nice for the company to say more about its choice, since the article does not list Docetaxel as one of the first few options .
The side effect discussion is of course a distant second to efficacy if efficacy can be shown with K.
The article is discussing a group of patients who are in a difficult spot- not responding to typical platinum regimens, with a relentless cancer, so side effects have real relevance.
Kevetrin has a real opportunity here, since current therapy has bleak prospects, and K thus far little in the way of side effects.
NEJM 11/19: genetic mutation assoc with cancer in 1120 pediatric pts. Most common was TP53(though only in 50 pts)
wonder about pump infusion, as you brought up in a prior post, given such a short half life
they must be wondering about this too(Menon Shapiro etc)
There are no good treatments for blepharitis, an issue prev addressed in this space.
With respect to conjunctivitis, very crowded space for drugs, so many quinolone options. I will ask local ophthalmologists if MRSA adequately covered currently and how big a concern.
Good work Farrell
Cell Host and Microbe(I know, a typical coffee table staple) article now making some headlines (see Google news) about MRSA getting worse if initially treated with a beta lactam antibiotic.
Unsure how valid the study is- but if there is any truth to it a clear benefit for Brilacidin.
This would mean that you might make a patient worse if you choose to treat an MRSA infection with the usual first line cephalosporin drugs such as cephalexin etc. That would make you want to start out in a different direction, different class of meds- if this study turns out to be valid
now you can go back to that very helpful article we were talking about earlier, p53 an Oncogene in Disguise, an article published earlier this year Cell Death and Differentiation. So much detail about the oncogene stuff.
Hard to wrap one's head around, all the p53 action
Jay Bradner, subject of prior post, who works at Dana Farber , soon to be chief of Novartis research arm based here in Cambridge- Profile in the Globe today mentions that his father died of pancreatic cancer.
Yes I know that all of big pharma has an eye on CTIX Kevetrin etc but am predicting again that if Kevetrin works then Novartis will end up the buyer.
yes asco 2013 Kevetrin poster shows PARP and PARP 3 cleavage as a target, among others
It is interesting to see how many targets Kevetrin has for cell cycle repair/growth/death, and how many ways it can impact p53.
Thanks for the link to the video. On youtube there is another video that comes up with the one you cited- it shows how PARP is involved with BRCA1 and 2 in some detail. I had never grasped that the BRCA genes were part of the whole repair process, hadn't ever looked at their mechanism in breast cancer despite their fame.
Pretty amazing that Kevetrin is smack dab in the middle of so much action
I thought we could all agree on the Breaking Bad character of the PRs and that might warrant a ....wry inner smile? No?
Pounds and purity. It is good stuff.
Breaking Bad PR almost!
Glad that some on the board find the Brilacidin PRs helpful.
Maybe there is more to come, more about the freeze drying, and how many pounds there are of Brilacidin, and its purity, etc
Maybe an update when it is 99.3% pure, or 99.5%?
or is 99% good enough?
I was looking forward to hearing how many pounds of the stuff they have now, since it has been a week or two since we heard last. Right?
The PRs are taking on a bit of a Breaking Bad quality- i do like that twist, i will admit
yet another no real news brilacidin news update?
It just seems desperate.
Much better than the shareholder letter to Joe which seemed like a school assignment of possible Ehrlich children, a real shocker
good find re p53 and advanced prostate. The study chose to mention the mutations their drug might help- so far as I can understand it
Excellent find/post fr nejm. Just out hrs ago! Only p53 not mentioned at all in the prostate article- that I saw, looking through quickly
Thanks captain obvious- I love this, I really do : I was faced with this moniker as I was called out by a poster earlier today(private message no less ooh la la)
It's so gratifying to know that the board is familiar with WBC production rates and neutrophil lifespans. It is almost embarrassing to admit that I had to look up this info, so that to think that the board had already carefully thought through potential bone marrow toxicity as it applies to Kevetrin half life and varying dosing intervals- well, it is such a relief.
I would not dare mention the lifespans of RBCs and platelets. I mean, it's just too...umm... obvious
Ok class dismissed. By captain obvious.
CTIX has to be sure about safety and hope to demonstrate some efficacy and the extension is prob seen as essential by DF and CTIX. O/w as you say move straight into phase 2s.
my point was that safety has yet to be established(not to mention efficacy) with new intervals
So do me a favor and explain the fallacies of my last post.
Why will Dana Farber and CTIX bother with testing new dosing regimens, about to begin any minute now, unless they really needed the information? This info applies to side effects as well as efficacy.
It is very simple. Recall that the MDM2 drugs got into trouble for immune suppression. Just review hematopoesis. How long does a neutrophil live? Days. The bone marrow produces billions of WBCs every day. If you give Kevetrin with a very short half life-HOURS- once a week then you gain some info about side effects but what about giving the same drug many times a week? Will there be any impact on WBC? Of course i do not know, but Dana Farber and Menon and Leo do not know either.
that is why of course that the additional dosing regimens were announced- to answer the question of side effects that might develop under different dose intervals.
Critical info. Clear?
CTIX announces that now- AFTER 3 YEARS-it will start to test Kevetrin as it should be given.
Really? Did it really take this long to consider multi week dosing in a drug with a half life of a couple of hours? After months of no toxicity at ever higher doses?
It feels like the newer doing strategies are a year behind where they should be. I still wonder what toxicity might be evident with the new dosing. Is this when we see neutropenia?
Those with more pharmacology background feel free to criticize this line of thought, but the company seems slow to move forward with diffferent regimens. At this point they have established that the drug is safe when it is given as they do not wish to give it.
We have said phase 1 is all about safety.
After 3 years of testing safety is NOT established at the doses that are needed- consider that as we move forward
Instead of shareholder meeting how about a candlelight vigil?
my guess is that the announcement will include the offer for 10 free shares of CTIX for all those who attend the meeting. By December maybe they will be able to offer 20, unless the share price rallies.
Oh yes. And a hat, as prev suggested.
woops- not calling for help from only one poster. Anybody else please chime right in.
Hey KMBJN respond if you wanna: new report out about nilotinib and parkinson's patients, and the use of a low dose tyrosine kinase drug to promote autophagy of alpha-synuclein tangles in the brain- as opposed to much higher doses stopping growth of WBCs Report on Saturday of a dozen patients(no controls) at a big neuroscience convention about apparently striking results. Study from Georgetown group. I know you have a background in neuroscience. I wonder if kevetrin might play some role in brain cell autophagy too, and how p53 might fit in with parkinsons and lewy body dementia- if at all.
You may well be right.
Hard to know about value of a shareholder meeting when we know basically the company has very little to say that is new- I would think. No way phase 1 done in 2 months, no news on Prurisol or B OM either in that time frame.
Could they be holding back anything given recent share price debacle? Something to share in december meeting? Not likely.
I suppose they might give out hats though...
would rather hear him talk about Kevetrin and where its headed and when. As I wrote yest timing of new trials not clear to me
I suppose we can ask questions in december
What do we call the new dosing protocols? I do not know. Post phase 1? pre 2? Certainly one cannot assume safety if given much more frequently. The MDM2 drugs got into trouble with immune suppression. Every day bone marrow puts out zillions of WBCs, which live days. Giving K 3-5 x a week will certainly mean it might have different side effects than current dosing.
I know nothing about the actual answers to these issues, but would like to. I posed the questions because they are the next obvious big issue with K that I can see
It will be good when ph 1 finally ends of course.
What about the next problem? The new protocols. Giving the drug 3-4 -5 x week at whatever dose? To what extent will safety have to be shown again?
We all hope that efficacy will be shown then, at more frequent doses, but will Kevetrin still have the same apparent lack of side effects? Will the new protocols require a much longer wait to prove safety, before the beginning of an ovarian ca trial, as one example, or can a trial start soon?
I do not know if Bologna and ovarian ca trials, and maybe pancreatic ca trials might see a start in 2016 or it'll be more like 2017/2018
Certainly will go if able, but December is very short notice , we can all agree
I cannot wait to hear more about lyophilization....
Very odd coincidence: note in advance: not writing this to solicit of bunch of sorry for your loss responses
just back from London after the funeral of my sister in law who survived longer than many with pancreatic cancer metastatic at presentation. As I have prev mentioned she had a p53 mutation.
Upon return, after being away from the web, I find quite a PR from CTIX. So different from so many recent PR's, this simply stated that the company is going after orphan drug status for pancreatic cancer(among a few other tidbits) while providing links for the elephant and cancer research.
Prev support for the ovarian ca application included info earlier in the phase 1 trial about tumor stabilization at 3 and 6 months. There must of course be some data behind this application.
Sorry to say this yet again but of course it is a key question: what will we get with better dosing, multiple doses per week? This waiting period is so difficult.
I have also written prev about that difficult transition as AIDS became a manageable disease. Patients whose health and lives were destroyed one year became survivors the next, still with us as new medical regimens transformed lives.
Are we seeing the final years of pancreatic cancer patients dying very difficult and certain deaths? Will Kevetrin be part of such a transition? That would be momentous. I remain excited about being a shareholder here as the story unfolds, and I am glad to think that CTIX has pancreatic cancer in its sights. As you all know, there are some cancers that you should not get. Kevetrin may provide some hope - who knows how much hope.
market goes up, and CTIX slumps again
how ugly can you get
oh yeah- I forget: it's a buying opportunity
as if we all haven't bought enough already
sigh risky biotech longer sigh inherent risk
30 pounds of Brilacidin produced? That is a PR? Sigh
Bigger than big news, if signicant efficacy, and not just a smidge
He has done well- he just got his MD in 2002! Just finished his residency at the Brigham in 2005.
You are bound to be right that large pharma is watching K and B, maybe P too.
That is what I find so hard to get about where we are now. A tiny company with amazing potential flounders...for the moment.
How long will it take for us to hear about the multi weekly high dose trials of K? Until we know if it really works?
Small impact on renal cell cancer gets a headline in the NYT for Nivolamab. Will we ever see those headlines for Kevetrin?
FWIW I have no insider info of anything at all. (I am a lowly ED doc and these are of course weighty matters) My posts are often snide or jokes but this is serious, obv
A Dana Farber researcher taking over Novartis research is a real opportunity for K /CTIX.
Oh yeah, as said prev
if it works.