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I thought so too, and yet..
C'mon release something about B-UP with a teaser about B-OM efficacy.....
It is less fun following the stock and the board when the share price goes down
So much for the notion that the rise would be followed by news.
8/7/14 first part of prurisol study establishes bioequivalence of abacavir acatate(prurisol) vs sulfate(ziagen)
next bit about to be reported, a noncrossover trial with 25 patients each group, one group placebo, one 50 mg, one group 100 mg and one group 100 mg BID. Observed for just 3 months(84 days)
There was suppression of CD4 (less so CD8)counts with prurisol in mice but less than was seen with a comparison -imab
Have yet to look up all the new antibody treatments to see their effect on CD4 counts- or Otzela for example
it means they have not figured out how to add anti pseudomonas activity to 1807 yet
I am glad to see the tape but still do not see any gates, flood gates or otherwise, being opened by an article about safety
I hope you are right and that I am wrong, and of course, we will have a chance to see for ourselves, eventually
When I keep reading posts about what a big and happy day it will be when the K article appears in the journal of successful phase 1 trials I am compelled to respond.
And your question, rightly so, is why? Hysterical, fixated? really, what is it? Is it too much coffee? Is it global warming?
sorry- it was a post I shouldna written
your posts are valuable-
Is once a day enough for the summary posts?
Maybe twice daily? Or how about hourly like the chimes of a clock? How about hourly, then?
i respect your measured wisdom and persistence, but....
And the orderly replies :
1)Even orderlies are now called techs in hospitals
2)If there were really big news to release do you think Shapiro and Menon et al would not have booked a spot at ASCO? There would be hoopla. In fact there would already be hoopla. Leo has released whatever he can about the p1 K trial - if it were anything BIG do you believe we would not know? Oh yes, the DF muzzle- it has not stopped any number of PR's about K.
3) As I have prev written- the paper will say that we have given escalating doses of a very short half life drug to patients with end stage solid tumors and it has proven safe. It is a great accomplishment, to develop a drug. But guess what- we are already beyond that grand huzzah. Those of you waiting for this paper to appear in some not so important journal, expecting more than I just wrote- well, good luck. It ain't happening.
4)All that counts now for k is the phase 2's and we need to start them, not talk about starting them.
no- do not believe manipulation I am sure we all think there is news we do not yet know
surreal
steady climb still no news
so present at ASCO and then have paper come out
If they do not present at ASCO already tells you nothing big new to reveal about rest of trial- they could make a much bigger splash at a well-attended well-covered conference
if you are right that none of that is known then there is a lot of info for a paper.However: Leo's style has been to release what he can despite the fallout over his disclosure of spleen lesion PR. One example would be his release of newer p21 data
That is why I believe nothing exciting will come out.
Why couldn't they do a paper and ASCO? Of course they could.
I agree they have made a huge amnt of progress
If prurisol and B-OM(interim) positive results announced it will be sensational-
I think new data would have been released already.
in reverse order, K: potential is only that, potential. Who doesn't appreciate potential? We need the trials to start already. What does it tell you that mayo /ctix are sitting around around waiting for a possible grant, who knows what chances? It tells you they have NO MONEY for a trial which would be a big deal if it can get off the ground. We do not need Leo to say they are applying for a grant with Mayo we need him to say they are starting a phase 2! This is BOGUS however promising. Yes and meanwhile we wait on ovarian p2 news...Why the wait. Guess what, people are dying, and CTIX cannot start its phase 2's. Of course you are right about the dosing issue as I have been harping on ad nauseum, and who knows how long it'll take to find the sweet spot as you call it. Wouldn't it be nicer to have experience with 3 or 4 or 5 patients iwth ovarian and pancreatic and renal cell CA at the proposed 3x weekly doses? You betcha. But no, not in the cards apparently. Also: Karen- why would a paper saying what we already know about K be big deal? It won't be- no new data.
B: Interesting comment about the dosing. I am a bit surprised too. Maybe they have other data? Very likely a success as we all expect. My very strong belief, now that they have freeze dried the stuff- infectious disease specialists convene to discuss antibiotic stewardship which keeps the drug off the market for the time being, in a negotiated agreement with Cellceutix. Would love to have some real ID experts weigh in on this, as the time comes. Your thoughts?
P- who knows. Appreciate that acetate and sulfate are different salts for abacavir.
B- OM. Sure, it'll be sensational if it works. I guess my own thought is that the run up is a prelude to news about B-OM and B-UP. But maybe that is too optimistic
Agree that it is a big deal and I was off base rambling on again about p2
But wouldn't it be nice if CTIX would actually start a phase 2?
agree- have said since first posts here a year ago that combo treatments will be the way to go-but it is obvious and requires no crystal ball.
Again I would note that no mention last p2 ovarian PR about monotherapy as one arm in treatment.
Sure, maybe they will do several different doses/intervals of K with docetaxel
agreed on this point, at least
You mean, for K, accurate for once a week dosing as opposed to 3x week, not yet tested in patients, never tried before, ever?
We all already know K was fine at tried and true doses
That is old news- good news yes, but old.
How about safety going forward? Nobody knows
Unless Leo has access to data already, he does not know- and nor do we- which patients with clear skin got the drug and which got placebo
Just look at Otzela- 6 to 7% of their control plaque psoriasis patients had PASI 75 responses
3 v diff drugs : or maybe he coulda said: PMX did most of the work with brilacidin, and P was a drug with a very long history of safety already, and K has NEVER been tested in humans at the dosing intervals we plan to give shortly and therefore(duh) its safety at these intervals is not yet known.
That might have been more accurate.
part of the reason for the accelerated path forward for prurisol was the fact that it is basically the same as abacavir/ziagen, a drug with a long history, with few serious side effects(except as we all know the hypersensitivity issue)
I think Leo and the science people did not expect serious probs- certainly I did not. It is part of the reason they were interested in prurisol from the beginning- clear path to approval IF efficacy due to very long history of use of abacavir
Look at the trial data for Otzela, as I just did. Response rates PASI 75 in just less than 1/3 of patients. This is for plaque psoriasis. I did not look through the data for psoriatic arthritis since Prurisol trial is for plaque psoriasis
Significant warning about depressed patients though small risk of depression.
30% response- lots of room for another oral agent
Re: the biologics- we have been over that
Too bad it was not helpful news, just a rehash of sorts
We need the news release that B-UP will start and that B-OM early data is promising.
We are waiting for that one, patiently, hopeful....
of course agree that the grants are no way to fund trials- it is competitive and no great hope that K will win out.
We should be funding the P2 trial outright...
sad state of affairs and part of the reason for CTIX invisibility
Could not agree more about wondering about how much company is currently limited by funding in progress with trials. Seriously- we are waiting to see if we get a grant to move forward with Mayo Clinic on a pancreatic cancer trial? An open competition grant that all kinds of other groups may well win instead of CTIX? It is a real problem I think- and it hurts us shareholders
On the way into work NPR had a story about health care costs, and they said, to my surprise, that the health care costs for those with RA and psoriasis are $89 annually for everyone who has health insurance. That is a large number for diseases which harm but rarely kill and is directly related to the high costs of all of those drugs which Prurisol might partly replace
Unsure how much to get hopes up about results, and unsure how far share price falls even if CTIX future does not depend on its success. Will Leo try to merge positive news with bad? If there is PR about starting B-UP that was supposed to come this month, hope it does not get pushed back into May to counter any probs with P trial data.
No article, my own rambling
Just putting down the thoughts of all of us I suspect
Also trying to console myself for buying so many shares at 2 and 3x current value....
Cellceutix and dark matter.
What a weird stock: unsure how often there has ever been such a stock.
In development currently, about to start phase 2 studies, is a potentially revolutionary cancer drug that could be in widespread use around the world for many cancers. There is a game changing mostly gram pos antibacterial that has already proven that it works as well as the best potential alternative, but with much greater ease of administration.(And without resistance!??!??) And this same antibiotic appears to have antiinflammatory properties that might work against mucositis(certainly some hints we will hear good news with B-OM).
Not only that, CTIX has a potentially very useful treatment for large numbers of psoriasis patients.
This inventory does not include a potential gm negative drug, or other possible uses for Brilacidin for proctitis or external otitis or conjunctivitis.
And while all of this is true, you can reach into your pocket, and pull out some change and buy a share, and the stock is traded in oblivion, and its products have all the visibility of dark matter. It languishes in obscurity in the pink sheets at just over a dollar as of early spring 2016.
Where will we be in 2020? What a story. What potential.
More recent PR- playbook plus one other- do not mention monotherapy
Here's hoping that our attempts at dosing do not take too much time to sort out- but, as discussed, Aprea just took 2 years on such a project. I really wish CTIX would proceed with some extra dosing of many solid tumors- but I have ranted about this for a while. They could gain such valuable info, that could inform p2 ovarian dosing certainly.
There has been no mention of K monotherapy in the last couple of ovarian p2 pr's, and I wonder if it has been scrapped. If so, that does not bother me as I see our future in combo anyway.
I will reread results page- I could only see the CA125 results for 2 patients as of the October results but they may have announced more
Spending a bit more time this morning looking at the PISARRO results from Oct. Aprea just spent 2 years on getting dosing decided for apr246 after their initial p1. they have published little about results- 3 patients showed decreases in tumor size- one impressive, the other 2 good not great. They report data for only 2 patients with CA125, with very impressive results- normalization of ca125. Yes I know that what count is survival and that these data do not mean the drug will prove out
Once again I express my doubt that ctix will be able to establish dosing that will be optimal without multiple different trial arms that will take time.
I am encouraged by the fact that both drugs are about to enter randomized p2 - but aprea has way more data on different doses at this point and has been able to show at least some response.
Caveats are that apr246 might still fail and that if K works better none of this will matter
I hope you are wrong
My guess is that we will get a PR suggesting B-OM going well and B-UP to start and then we head up.
Since a B-UP announcement was mentioned for March. I hope they stick to this time frame
Surprised does not begin to cover it.
How that email exchange can possibly be true is shocking. I suppose it can only mean that Leo is much further away from the science than I would have thought.
How can he not know about another p53 drug in a trial for ovarian CA? To email him info about apr246 strikes me as ludicrous, and he should know all about it- then he says thanks for the info?
Bizarre
helpful links. There are the straightforward details of one current competitor- 6 hour dosing 4x week 4 days a week. The patients will certainly wish they had a pump option , even if they are binge watching House of Cards. Where apr-246 has an edge is that the drug has already been given in different doses as part of the p1b, whereas K dosing prob not dialed in- that would be my guess only, and those trial pharmacologists may know better.
None of this matters except efficacy of course. Prob both drugs will be available here in Boston soon, but as noted , for different groups of patients- relapsed, but platinum sensitive for apr246 /carboplatin versus platinum resistant for K/docetaxel
VRSA- ever heard of it? Ladies and gentlemen, an item of interest. Flipping through the pages of this month's annals of emergency medicine one finds , on pages 386 and following , a brief discussion of Vancomycin Resistant Staph Aureus, or VRSA. Yes of course we all have heard of MRSA but VRSA was new to me. The article was reporting on the 14th known case of this infection in the US, from a dialysis patient with a diabetic foot infection, in Delaware, in 2014, with the isolate characterized at the CDC in 2015. The article comes from the MMWR but is in this month's emergency medicine as noted with a very nice background discussion of staph infections. Penicillin routinely killed these bugs until the 1970's when MRSA emerged.
The paper mention 14 cases now known of VRSA starting in 2002- only a handful of course, but stay tuned. MRSA of course now a MAJOR problem not just for skin but for hospital acquired pneumonia as well, just to name one example. But of course this is old news. VRSA might be old news in a generation too
VRSA resistance was plasmid mediated with transfer from a VRE- vancomycin resistant enterococcus, which is much more common.
What does this portend? Obv that a drug like Brilacidin will have more importance if there is spread of VRSA and that is likely.
Just thought you might want to know - for me this was all new info.
sorry no internet skills to post link. try google aprea ab and business wire Stockholm Aprea AB closes 46 million Euro.... and that should get you the article