Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Oh-woo are we talking left or right? Keep in mind your kicking foot. And although I thought I saw that on the Mcdonalds menu may I suggest sticking to the 99-cent menu. =-)
What an amazing time-line we are looking at for the first half of the year for CTIX. Exact placement of many events is difficult to judge. Guess-estimates were made on the date of the PR and information in the PR. Sprinkle amongst this list continued updates from Kevetrin P1 at DF and BIDMC and a host of other unknown developments due to statements such as “ initial discussions with the National Cancer Institute and other university hospitals are underway”. Particularly difficult to place in a timeline is preclinical release/published data from BIDMC, University of Bologna etc. Things are heating up here over next 5 months. Here is my highly speculative chicken-scratch list:
February 2013
Announcement of SW cancer center sponsored studies in myeloma. From the 12/31 ” We have now signed a Non-Disclosure Agreement with the Cancer Center and are quickly moving forward with a Material Transfer Agreement. “
Announcement of an additional sponsored study at University of Bologna. A pure guess here but from the 12/31 PR The University has indicated they are interested in a second study of Kevetrin in combination with a compound of a major European pharmaceutical company. Stated before actual name of the University was disclosed. Remember disclosure of this co-operative effort was first announced in September 2012.
March 2013
Not sure how this will be dispensed to us but We are now looking forward to receiving data from the p21 biomarker studies which is expected in March 2013.” So let it be written so let it be said, potentially huge news here, IMO.
Late March to early April 2013
Prurisol PoC phase 2/3 in Europe starts! Second drug in to trials, huge news here IMO. Thanks Progressive
Late May early June 2013
ASCO! From 2/04 PR The ASCO meeting gives Cellceutix an opportunity to provide a comprehensive update on the latest data from the Kevetrin clinical trials to shareholders and leaders in the scientific community as well as time for interaction with others about possible future collaborations and studies. Again huge news here IMO.
Plus Splice these in to the First Half of 2013
Start of University of Bologna sponsored phase 1b trial “A Multi-Center, Open-Label, Phase 1B Study of Escalating Doses of Kevetrin (Thioureidobutyronitrile) Administered Intravenously, with Cytarabine Adminstered A) Subcutaneously, or B) Intravenously, in Patients with Acute Myelogenous Leukemia (AML).”
Start of BIDMC phase 2 Kevetrin and sunitinib in RCC
And then Results Prurisol phase 2/3 PoC
LOL, I get busted big-time on that one. I just clicked post on that heart-felt message about keeping your emotions in check, which I hope many of you will read, clicked on my email and saw the PR, went right back to the board and posted emotionally un-checked message. It all took less then a minute and here is another funny-kicker my lunch time is over!
In a attempt at salvation, I am going fishing this weekend! And thanks to your comment adding a new rule, no more checking stock price on the weekend! And remember "DO AS I SAY, NOT AS I DO" =-)
GO FISHING AND GO CTIX
ASCO! We got it!
Keep'in it cool is my new Rule. As a few have posted here about maintaining civility on the board, which I appreciate very much, I thought I would throw in my 2-cents.
Keeping your emotions in check when it comes to this company is difficult because the potential is so incredible, truly the sky is the limit. I tend to find myself in mini-break-downs on the subject roughly ever other week. On any given morning I could wake up, get my coffee, sit down in front of the computer, turn on the live-stream, drop my coffee and say OMG I am rich! Its not just the chance that it might happen but I have come to believe it will happen. We talk about 10 billion+ market caps, licensing and buyout deals, and although seldom if ever mentioned on this board but in the back of my mind a dam cure for many forms of cancers, OMG literally.
I am a long investor and I know how to go long but how did I ever give myself that title being the emotional-basket-case that I am now? I bought seattle genetics back in 2008 followed the majors events, took my base off when appropriate, took profits accordingly and am still holding a few shares. I bought CTIX 3 years ago, took my base off this last X-mas eve plus a small profit. Why am I so pent up? I am sitting on a free-ride with good grip of shares!
In order to curb my situation I came up with a few rules: I will not post my emotional breakdowns on any board because they will often elicit emotional responses from others. I will only check stock price/boards 3 times a day: in the morning, lunch, and after work not when I am talking to others or walking down to the bathroom from my office, darn smart phones. This last one is very specific to me, I will start going fishing again because when I am fishing, I am fish'in!
Just saying, PEACE, Go Fishing and GO CTIX! =-)
Cellceutix's Kevetrin phase 1 DF open-label efficacy measures as a secondary outcome and Prurisol in phase 2/3 double blind but short duration, 60 days. This company is trying to tell/show us something in quick fashion.
I would assume Sunitinib alone would have been compared sunitinib+Kevetrin and a control. I am sure BIDC will publish a peer-reviewed article, perhaps at ASCO!, on the experiment especially because they are applying for a grant.
If you search the web there is a lot of theoretical research done trying to tackle drug-resistant 786 in RCC so we know its not easy. But we will get a "free" phase 2 human trial in combo.
We will all have to excitedly wait for the paper because they probably won't leak much until its published. We know that BIDMC is a leader in this fight so I will remain impressed by their comments.
In response to:
"How are the researchers and/or company attributing that Kevetrin has made a difference and that the observed shrinkage is not due to Sunitinib ? Is there a article to show that sunitinib is not effective in cell line 786 ?"
Leo has me spoiled I will be disappointed if we don't get Friday AH or weekend PR update on DF p1. I would like to hear what the status of the cohorts is, safety committee cohort 2, cohort 3? And although cohort 1 is benefiting from Kevetrin at the original dose it would be nice if permissible to move them up to the double dose of cohort 2. Any PR of course will contain a comment from Dr. Menon that we can analyze for the next week and beyond.
Right, I was so happy when I read that I was probably jumping up and down screaming It Works! And I probably did the same when I read:
"As we await the lab reports, it’s very encouraging that we have not seen any of the toxic side effects that are commonly associated with chemotherapy at this point. Many new drugs demonstrate toxicity immediately, so I interpret the information on Kevetrin™ with a great deal of optimism."
Perhaps my epiphanies are a result of a bad-memory. Thanks Gov and TOB for the re-enlightenment. Wait just one more epiphany why do we have such a crappy market-cap.?
EPIPHANY! Okay that is crystal clear now. Sorry you went though all that work to get it through my thick-head. The significances is that cohort 1 is CONTINUING to be dosed so the dose is known to be tolerated already then why continue unless their was a benefit! My wife is right I don't listen.
Wait a minute...and...another epiphany YE-HAA!
That is amazingly good news!
CTIX does not have an after-hour market (OTC). What you see there is the last trades of the day that were recorded late.
Forgive me if I am wrong, but I think DocF mentioned that the initial dose on cohort 1 is below the dose (in mass) of what it took for the marker to show up in mice? I believe, again please forgive for miss stating, he also said that the dose overall though was rather large compared to other drugs at similar levels of development.
This is a chemo-drug in order to get the correct level of interaction between the drug and the target I would think that you would have to dose it at a fairly high levels? If you just think about "chance encounters" you have to dose high enough so that it encounters a cancer cell before the drug expires. I have no idea what Kevetrins affinity is towards cancer but I don't believe it has a positive feedback reaction/loop. For example, Kevetrin interacts with a cancer cell and "cures it" then that cell goes onto interact with another cancer cell and cures it. In fact, from what we know it does not do this rather it encounters a cancer cell and kills it.
My gist here is that Kevetrin may well have to be dosed at relatively high levels to get a proper level of interaction with cancer cells.
That doesn't make sense to me reading the protocol that anyone would word it in such a way. If you just look at the dose schedule for the cohorts it is double each time for the first 3 cohorts then quartered there after. My perception of this is that they suspect MTD will come sometime after the 3rd cohort.
I mention this just to point out how small the first dose was...And to say in advance that if Kevetrin does not perform a miracle, which to me it would be, in improving or stabilizing this Patient Population (near death) the trial will not proceed beyond the first cohort. Its not a matter of spending money on a dud, its a matter of common sense.
I would have dumped my shares if would have read that phrase in the protocol the way I read it now. It would say if Kevetrin doesn't perform a miracle on the first dose its over...who would invest in that? Maybe the loophole here is the use of the word "scan" if scans are done, but how would rely on the act of ignorance to sustain a trial.
As always, just my opinion
ps...I hope we did have 3 miracles in the first cohort
So your saying we can go to The Big Show! Thanks a lot Doc, know that's the spirit!
Thanks and while they cannot present results phase 1 DF.
They still can present!
In the past he has done ASCO presentations on phase 1 trials!
Holy Cow! Our second favorite Doc Geoffrey Shapiro, MD PhD favorite pass-time is apparently presenting at ASCO! Google his name and ASCO and he is all over the place. He had 10 ASCO abstracts last year!
Here is just a few links
ASCO 2012
10 abstacts
http://meetinglibrary.asco.org/speaker/Geoffrey%20Shapiro
ASCO 2011
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=80274
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=76604
ASCO 2010
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=74&abstractID=53257
ASCO 2009
http://exelixis.com/sites/default/files/pdf/XL147-001_ASCO-2009.pdf
4 abstracts 2009
http://meetinglibrary.asco.org/speaker/Geoffrey%20I.%20Shapiro
If I get time I will try to look up Dr.Shapiro's record to see if he has a propensity to present at ASCO, see if he/she has done it before.
Our best shot at ASCO might be the preclinical work at BIDMC or perhaps other preclincal work. It would be interesting to see though if Shapiro has something abstract-worthy to say about the first cohort of which I am sure the data has been well digested.
Dr. Menon's comments were around the time of last years ASCO and there has been delays in DF phase 1. But, I would love to see a abstract there. I know its tight but blood analysis/scans cohort 2 could be in play??? Even the preclinical data from BIDMC on renal cancer, which was huge news, could be presented. There is so many articles written about ASCO plays to investors on a National Level! It is the super bowl of biotech stage.
We have a week to find out if we are going to the "BIG SHOW"!
Plus it will be fun to see how many of our IHUB board readers are active/swing traders and start buying in tomorrow tradings.
LOL, I know there is a lot of swing traders on this board. Imagine CTIX story on a national platform!
Here is CTIX ASCO 2013 comment.
"Dr. Krishna Menon, Chief Scientific Officer at Cellceutix commented, “I will be attending the American Society of Clinical Oncology (“ASCO”) Meeting in June to continue discussions regarding Kevetrin™. We anticipate that next year we will be presenting data from this year’s planned clinical trials.”
Link to whole story
http://cellceutix.com/cellceutix-files-amended-ind-with-fda-for-its-novel-p53-guardian-angel-anti-cancer-drug/
Could you imagine the sustain upward push of pps of CTIX if they PR'd that the team at Harvard was going to present at this years ASCO! ASCO is in May imagine the ride we would go on from now till then.
ASCO 2013 abstract submission deadline February 5th. I cannot find the PR right now buy I swear Leo said they will be presenting.
I guess the gist of that whole thing is that Kevetrin re-activates wt p53 bringing normality to a cancer cell. Now this normality could flat out kill the cancer cell or just normalize it enough to make other cancer drugs effective against the cell.
Thanks for mention there. When I started thinking about combination therapies for Kevetrin, Micromet came to mind. Micromet which was bought out early by Amigen for 1.16 billion last year had a drug that was essentially designed for combination therapy. If I remember this right, cancerous cells plasma membranes (outer layer of the cell) get modified making it difficult for cancer-fighting drugs to permeate the cell. The cell would essentially loose the ability to communicate with the outside environment. Micromets drug normalized the plasma membrane of cancerous cells allowing them to be susceptible to cancer drugs from the outside. Pretty neat technology because it has the potential to work on numerous cancers.
I was wondering if Kevetrin may have a similar action. By normalizing cell pathways allowing wild-type p53 to dominate, it could also normalize the plasma membrane or just normalize the cell in general. The interactions inside the body are extremely complex, mind-numbing so, but if you could imagine Kevetrin moving through the body. The cancerous cells it comes upon could result numerous outcomes. It could, as advertised, knock out the dominate mutant p53 allowing wt p53 to dominate leading to cell death, reactivate wt p53 without leading to cell death, do nothing at all or create some kind of co-dominance between wt p53 and mutated p53 etc?
The MTD and DLT of Kevetrin is very important. If the MTD is high enough you could drive the equation, the flow if you will, towards cell death? It was found a long time ago that antibodies by themselves were tumor suppressors but you would have to flood the human body with toxic levels to get effective tumor suppression. Seattle Genetics work here is impressive, but a long road to broad application due to specificity.
Kevetrin is a broad drug in that it will be simply circulating in the blood system with little specificity/non-targeted relying on chance encounter with a cancer cell with the odds of which depending on the dose (MTD), but honestly I have no idea how much affinity Kevetrin may have towards cancer cells.
So if Kevetrin cannot be dosed in humans to totally drive the equation to 100% cell death a 100% of the time. Dose it at lower level where it takes out some cancer cells directly, normalizes others or otherwise modify the cell and allow perhaps a more specific drug take out the stragglers.
If some of this is true Kevetrin would be vastly superior to Micomet's drug because Kevetrin itself is a direct cancer killer and better than Seattle Genetics technology because it is not specific. Of course, Kevetrin alone may have enough affinity be stand-alone treatment for many cancers and for the others it can be enhanced in combination therapies? If we look at the combination trials planned for Kevetrin it is going up against some of the worst cancers known and we all could use a helping hand at times.
This little rant here is brought to you by my:
Wild speculation
Bad science
and the boredom of a Sunday evening.
Go CTIX!
Thanks a lot Dr.F. That response is crystal clear to me.
A interesting thought about the current DF trial and when you consider the potential of combination therapy. We don't necessarily need to have incredible tumor reduction rates coming out of this p1 trial rather signs of activity and low-toxicity.
I have a question for DrF too! The combination study at BIDC with an approved FDA drug is allowed to use the MTD from the DF study couldn't all further combination studies with approved FDA drugs start out at a advanced stage? The European study is starting out at phase 1b (which will be using the MTD from DF??) but if they find strong preclinical results couldn't they too could switch from phase 1b to 2?
Kind of a exciting thought if we can have Kevetrin in combination therapies with approved FDA drugs in numerous phase 2 trials in relatively short-order, well as far as clinical trials go. And if shown these studies provide great benefit to the patients with little toxicity we could have FDA approvals after phase 2!
I believe seattle genetics got approval for Adcetris after a phase 2 trials with 85% patient benefit. Kevetrin in combination phase 2 studies could well hit or exceed that number.
Always fun to speculate.
Thank you, nice find, interesting article. I always curious about the companies use of the term "reactivates P53". Looking at this article the method of action of kevetrin maybe removing the dominant-negative (DN) effect of the mutant p53 gene over the wild-type p53 hence reactivating it.
Also Kevetrin alone in preclinical tests was such a powerful tumor suppressor now we can couple Kevetrin with a host of cancer drugs perhaps drugs that are more specific (targeted) to a certain type of cancer and WOW.
I was 100% certain Cellceutix was a buyout by the end of the year, now somehow I am 101% certain. What large pharma would not want to couple their cancer drugs with Kevetrin and repatent it in combination therapy?
Wouldn't you agree that to some degree its the companies job to promote itself just not have its faithful retail investors do it. Of course and let me say that again, of course their main objective is to get these drugs through trials. But in the years of holding this stock I only know of one investors conference for example.
It makes me think of how few investors know of this company when the main support is "in house" buying. We are all exciting with these PR's but we signed up for them. I only hear of CTIX on the outside because I have them in my Yahoo and Google portfolio etc. The "active traders" to me are too satisfied with small profits here. Truly, sad that New York Times article got botched.
I am sure their are some investors/MM that cannot buy in yet but know of the company and other side-liners. We are under-exposed to the investment community, but could you imagine how much this stock would soar if the company announced they were presenting at a investment seminar in 2 weeks?
Problem here is that longs would probably add more and I am guessing many of us, including me, are already over-exposed. I base this on the apparent hyper-sensitivity some longs have on this board to anything being posted that they perceive as negative or sometimes just even neutral. I have not seen a relevant point brought up by our CTIX bashers on this board but everyone responds to them dragging their posts to the top of the board.
As always IMO
Go CTIX
For the life of me I cannot figure out why people are selling at this level.
My take on the PR is simple. They will continue with the phase 1b as planned, but are already planning for phase 2, hopefully on grant money which I am certain they will get for this indication. No, they do not plant tumors in humans preclinical or clinical to see if they can cure it.
Although sunitinib is already approved they will have to look dosing, safety, drug interaction etc in humans. I pasted some definitions for phase 1, 1b, and 2 below. Great news here on several levels including some fun speculation on how well tolerated Kevetrin is doing in the 2nd cohort at DF.
As always just my opinion.
Go CTIX
Phase 1
A clinical trial that usually tests a new treatment in a small number of patients in order to determine the safety and appropriate dose of the new treatment.
Phase 1b
A clinical trial that usually tests a new treatment in a small number of patients in order to determine the safety and appropriate dose of the new treatment. Phase 1b trials may also test the treatment in combination with other drugs or agents.
Phase 2
A clinical trial that usually tests a new treatment in a small number of patients who have the illness that the drug is designed to treat. Phase 2 trials measure efficacy as well as safety.
That was nice work..with volume too
Since ctix is on the OTC market where there is no AH its probably the last trade of the day or the close but it didn't get recorded in time so they list it as AH.
Why is that funny?
After hours trade
Link to CTIX buyout prediction article from a highly questionable source at best but as always nice to hear.
http://sierraworldequityreview.blogspot.com/2013/01/still-waters-run-deepkevetrin-producing.html
So at best cohort 2 is in the 3rd week of treatment now with next week off and then the safety review board? If so, my disappointment would be that the 1st cohort likely will not have the opportunity to take the double dose of the 2nd cohort because it would have not been cleared by review of the 2nd cohort before they start their next cycle?
I am not disappointed that the 2nd cohort had a delayed start just confused that it was stated that they would start Dec. 16th. That means the second dose of the 2nd cohort would have been done around Christmas. I can only guess at my mind-state if I was a terminally ill cancer patient, but what would I rather do, spend what should be my last x-mas with my family or be strapped to a IV bag for 8 hours getting poked with needles and on a experimental drug. Hands down, I would be with my family. Just a personal opinion.
Thank you The Progressive for the best SA article I have read about our company. Well done indeed. The other SA article released today was okay, but I got the feeling the whole thing was a "cut and paste" job.
I was not attempting to scare anyone, purely hypothetical, and I am patient, been holding this one for years. I concur with others that a RS is highly unlikely, though I personally wouldn't be opposed to it if straight forward and got us to a decent exchange (some exchanges require a certain PPS). A up-listing could bring in a slew of new investors and remove some of the blatant manipulation. Most people won't touch "stinky pinks" except you, me and the swindlers. Management may not even be interested because the drug(s) will be worth what they will be worth on any exchange?
I believe this company will be bought-out before the end of the year. Uplisting and appreciating the market cap. is important when it comes to the buyout price. I don't think big pharma is going to give us $100/share when the current price is a shaky $2. Given what we know of this company right now our market cap. should be over 500 million so what is holding us back? I say don't worry about rs, it won't happen, but "Leo please upgrade our exchange".