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.
What is actually driving this surge right now? I have not been following things well, been in China the last month. Brilacidin 2b report is ~6 weeks away. RR is ~3 weeks away. IND for B-OM? Kevetrin cohort 8 should be anytime, but cohort completion here has never seemed to be a catalyst before? A mix of all the above and more? Lord forbid the market has woken up?
Any thoughts? Just seems to be a bit early..
That response from Leo was about 7 days after I sent it. Interesting for me was formulating Brilacidin? They may still be working on a formula for B-OM?
The update, on all in August??? I thought such an update perhaps would be at the RR conference in September????
Response from Leo:
Hi,
Yes we have registered to present at the conference and again yes, during the month of August there will be updates on all our programs. Right now we are focused on completing the phase 2 ABSSSI trial, and formulating Brilacidin for our planned projects.
Best wishes,
Leo Ehrlich
Hello Mr. Ehrlich, I am a long time investor and "fan" of your company. I know you must be extremely busy but I was hoping you could answer a few questions?
Do you plan on presenting at the Rodman & Renshaw Annual Global Investors Conference this September 2014?
Also do you have any updates on Brilacidin-OM status?
Any updates on Kevetrin?
Thanks for your time, Dave
The big 3 are all in play here for a PR. Kevetrin cohort 8, Prurisol crossover results and Brilacidin enrollment completion. Also B-OM, K BIDMC, K at U of B...and on, on, on..
Three weeks without a PR?? With all this news event potential at this given time and our CEO's proclivity to share all he can..something got to be cooking here!
Unfortunately, I recall making a similar post about 3 months ago, but its different this time right? =-)
Asta, Prurisol is a tough sell to me in the short-term. If it makes it past the cross-over it won't be much of a catalyst but if some reason it fails it will drive us down.
Yes! Well. Should be
Well, I don't know much but I am pretty sure Leo cannot go more than two weeks without a PR especially with all that is going on. Check your inbox tomorrow morning.
Hopefully when comes to partnering its only Brilacidin and not the whole defensin-mimetic platform. Brilacidin would be the only one properly vetted to equate a value. I think the platform is stronger than most realize and to lump in the whole platform with a B deal would be to under-value the rest.
On the science-side in regards to polymed compounds their big failure was the anti-coagulant Delparantang that was not part of this platform. Interestingly though if you look at the data on D interestingly it may have the same issue that B had in the 2a trial...Dosing. I would not be surprised if Cellceutix brings up Delparantang again in the future. Either/or reformulated or alter dosing strategy.
NR, IMO Aspire-effect.
They announced they were attending the RR conference last year on August 12th. http://cellceutix.com/cellceutix-clinical-study-on-its-anti-psoriasis-drug-prurisol-to-commence/#sthash.SvFItdlq.dpbs
Come on Leo give us that secret update on K at the RR! Wink, wink!
Easy Aspire, easy its win/win if you let this close in the green. So many shares bought over, well the last year at 1.65-1.70 I would not think retail is flipping this on a penny? With catalysts pending? Perhaps they will be out of shares for tomorrow with this surge =-)
Thanks INH, I assumed it was the Aspire broker went out for lunch. All green flags this thing has to snap sometime soon. I assume in anticipation of B 2b enrollment completion.
Either way this should be fun to watch this week.
Is it just me or did the volume completely drop off at east coast lunch-time then pick back up after lunch? I am looking at the delay on my cell phone and I'm not exactly tracking time that closely.
If so it seems like someone's job is to buy and/or sell CTIX stock?
If the company is doing any kind of formulation work for the B-OM IND it can take longer than expected. They generally under estimate as is their time lines.
Thanks Gov, that is what I thought then and still believe. I am sure you recall that right at the start of last year's RR Leo made the comment that the company plans on uplisting, "without a reverse split" now that is a meatball you don't put out there and not execute on perhaps a red flag for some. I think Leo was confident in the slides and the acquisition but misjudged market reaction to the PoC. Despite my feelings at the time, really a bit of disbelief, I was so impressed with that Kevetrin data, really the first we have ever seen, that I bought more shares as the stock was tanking. I felt comfortable I knew why. The stock has been flat every since. But it is all speculation on my part, of course.
IMO this was worst move the company has made but they turned around and perhaps made the greatest move I have ever seen in a small biotech. Not only the purchasing Polymed assets and a understanding of what they were purchasing but bringing Brilacidin back in to trials so quickly. Truly amazing "break-neck" speed.
Amazed..from RR 2013 to RR 2014 they took Brilacidin out of the closet and will have nearly completed a phase 2b...in ONE Year!
I am just happy to see some people posting! There was only like 4 posts today! What am I supposed to do when I am waiting for my slow barista to hand me my coffee? Call my wife? Ouch! =-)
Sox, I am sure you remember last year RR conference when cancellation of the PoC was announced. The slides for the presentation were leaked out onto the internet a day earlier. If I recall correctly nowhere on the RR slides did they state the PoC was cancelled link below. Before the presentation the stock was surging ~2.20-2.32 somewhere around there on the information on the slides about Kevetrin and to some extent Brilacidin. Not long after Leo spoke the words that Prurisol PoC was cancelled "we are a much larger company now" the stock tanked.... as soon as he said it and it closed down for the day.
Not only did they remove a near-term catalyst in scrapping the PoC moreover to me at the time the company seemed to be wreckless scrapping a trial right before its start. Also this came with long delays already with Prurisol causing me to believe there is a issue here. Were they fighting against the need for a crossover study in Europe too?? The polymed deal sounded great. Getting all that for 5 million seemed to be win/win.
I think obviously the crossover study in the US cost less than the Prurisol PoC in Europe. But if you factor in what the move may have done to the companies market cap. especially with Aspire financing we may have lost money. Also the crossover study does not tell us if Prurisol works the European PoC would have. Now we pay for crossover and the PoC.
The information on the slides alone could have gotten us up listed!
Not bashing here but the move was my least favorite!
My new B-Big-Bang Theory! So I have been wondering for a long time now why this company is so undervalued! Under the radar..sure this is true some extent. Lopsided share structure concerning some..perhaps. But I believe the real problem is that of a question of integrity? And here is why from our little company..
(please note comical nature here)
Prurisol
The cure psoriasis (my words not theirs) really? From the website:
Prurisol (10 mg/kg PO twice/ day x 21 days) » 84% reduction in lesion appearance, » 99% reduction in lesions based on histology,
» 96% reduction in serum PRINS, » 87% reduction in serum IL-20,
» No reoccurrence of lesions within 180 days,
Oh...it is also an oral drug that is well tolerated-yikes!
Brilacidin
A novel antibiotic, well here from the website:
Brilacidin has the following attributes:
– potent and broad spectrum activity.
– demonstrated activity against drug-resistant bacteria, including methicillin-resistant S. aureus (MRSA) and vancomycin-resistant —-enterococcus (VRE).
– concentration-dependent killing, long half-life and post-antibiotic effect allow for shorter therapeutic regimens than conventional antibiotics.
– rapidly bactericidal, killing bacteria in a matter of minutes, which minimizes bacterial mutation.
– selective for bacterial cells versus mammalian cells.
– stationary phase activity aids in eliminating persistent organisms.
– bacterial resistance has not been observed in serial passage studies.
PS We have 16 other compounds in the defensin-mimetic platform. And we are going to see if we can do a l-day 1-dose treatment with Brilacidin in ABSSSI. And there is billions of dollars more waiting once we start sticking Brilacidin in your ears, eyes and on your feet!
Kevetrin here is the craziest one yet from the company website.
"Kevetrin’s primary mechanism of action has been shown to induce activation of p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. p53 is a tumor suppressor protein that is encoded by the TP53 gene in humans and has been widely regarded as possibly holding a key to the future of cancer therapies." "Kevetrin has demonstrated potent anti-tumor efficacy against various carcinoma xenograft models: lung, breast, colon, prostate and squamous cell carcinoma, and in a leukemia tumor model. In drug-resistant cell lines, Kevetrin has shown excellent activity, galvanizing the Company to focus on Kevetrin’s development potential in this area."
Lets face it this is all crazy talk! Three block buster drug from a sub 200 million company that was trading for pennies just a few years ago. Dr. Menon and Leo you must be full of shXt! But now to my B-Big-Bang, its the B-Big-Bang theory not P-Big-Bang because the cross-over success wouldn't be a catalyst. If Brilacidin in any of the arms the 1's or the 3 day 2b study are comparable to Daptomycin people have to say "Hey these guys are not crazy/full of shXt". We will not only get the added value of Brilacidin success but also added in value from K and P because people will have to say maybe these two other crazy stories (K and P) are not so crazy after all! And Brilacidin is coming soon!
If Dr. Menon and Leo aren't crazy that should make me slightly less crazy for believing in them!
Just Rant'n
Funny thing about today's PR. Its hard to get too excited about a solution to a problem if you didn't realize there was a problem in the first place. Having said that it is impressive that they were able to tweak the formulation.
It feels like momentum is building in the stock price but is seems a bit premature. I thought we were still a couple of weeks away from an upward push.
Go CTIX
And 30-60 days from the dose escalation phase of K p1 IMO
TD I hope it does too but if you throw in the length of cohort 7, I mean come on how long does it take a nurse to change the infusion rate on a perastalic pump? And Dr. M just this Monday changing the primary completion date to September normally I ignore these dates because they are so...well "random" but with the wording in the last PR it sounded like Leo was not even sure there would be a cohort 8.
Why we DLT soon and perhaps its just not what I think but what the company is telling us. Look at the following:
Cohort 5 75 mg/m2 9/2013
"Regarding Kevetrin, Cellceutix would like to inform shareholders that the fifth cohort has been completed and we anticipate the dosing will be increased for the next cohort."
50% increase C5 to C6
Cohort 6 110 mg/m2 12/2013
Kevetrin: "The sixth cohort has completed dosing in the Phase 1 clinical trial of the Company’s anti-cancer drug Kevetrin being hosted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. The safety committee is scheduled to meet in mid-December to define the increased dose for the seventh cohort."
50% increase C6 to C7
Cohort 7 165 mg/m2 3/19/2014
"We are excited that the seventh cohort is underway as we feel that we are drawing closer to achieving MTD, which represents a milestone for our Company,” commented Leo Ehrlich, Chief Executive Officer"
33% increase C7 to C8
Cohort 8 215 6/14/2014
"Cellceutix anticipates that dosing will be increased by about 33 percent, or approximately 215 mg/m2, but there are no assurances as any dosing increases are at the sole discretion of the safety committee."
Not only did dosing increase drop to 33% look at the comments given at the time each new dose was announced. Dose increases are determined by the number of Grade2ae events and clinical trials follow these protocols. They went from confident of a dose increases C5 and C6 to close to MTD in C7 to "there are no assurances" of a dose increase for C8. Folks, I believe we are very near the end of this trial, very exciting.
I would hope we could make it through 8 and have the MTD at 215 mg/m2 above efficacious range but we might end up 165 mg/m2 which maybe a sweet spot as well.
Biohedge, nicely said my perspective as well
Hey Bobby, isn't that the name of that new Chinese car that they want to start selling in the US? Not much of a flipping stock here perhaps try something with more volume. Too many of us darn longs here=D
Tom, its most likely Aspire selling. IMO
Sox, I think your estimate of enrollment completion for B is more rationale then mine. I am a big fan of irony having enrollment completed around the same time as the interim report is right up my alley. Win, win we are way ahead of schedule regardless. I am amazed at how quickly this B 2b trial has moved along!
Come on 1 day treatment and a quick FDA approval!
BK your welcome. Great read, sounds like confirmation of B destablizing cell walls, having a fast reaction time and no signs of resistance. Unfortunately, I cannot copy and paste from the report.
Brilacidin seems to share some of differing strong points of both Dapto and LL16.
Thanks again!
Thanks BK! It worked for me.
I have no doubt that Jerry is out on reconnaissance collecting super top secret information that he can share with the board. Shh, the rumor is that he already spoke to cousin timmy and uncle tom. Its either going to be super fantastic news for CTIX or something really bad. But no doubt it will be certain as long as he does not mix up his handles we might be able to understand it.
Anyone else think we will get news of enrollment completion along with B 2b intermin report? It is plausible.
Darn Pfizer, ruin it for the rest of us.
Ovidius, my experience with large pharma running trials is you don't hear much of anything until the trial is over..good, bad or ugly. Leo has already given us more information on the K trial then I thought I would ever get till it was over. And I do assume he is not lying in his presentations as far as poster posting emails from Leo on this board..I take them with a BIG grain of salt and if I could emphasis this last part more, I would. BIG GRAIN OF SALT
The big number from the preclinical work with K is 200 mg/kg we are just now starting the first cohort at this level (215). We had some stabilization at 75 mg/kg or less then first case of regression 75-110 mg/kg. VERY EXCITING TIMES. And with B incoming in a week or two then P conversion. Lordy, Lordy look at that the RR conference in the first week of September where Leo notoriously always spill the beans!
Well I am excited I don't give a shxt if anyone else is..but you should be.
P.S. I had my emotional breakdown with CTIX last month Gov helped me through it all perhaps she can help others too.. Thanks Gov!
Just rant'n
Tick-tock, tick-tock, tick-tock
Ovidius, how could you tell if it was or was not turning heads?
"when the reality is Kevetrin is not turning heads in the Pharma world"
The company has signed a lot of NDA's and has combo trials lined up. Its still in phase 1! Until we have some concrete facts it would be unwise for the company to start selling off parts of the ship before they leave the dock. I would hope they would not complete any deals with big pharma till p1 is over. The value to us only goes up. My understanding was that Leo in terms of K would only be looking for partnerships with universities and the likes for essentially free trials but these types of partners take time.
LOL, some of you are trying to pull this down before what should be the biggest catalyst of the companies history to date...a interim report on B. If there is no significant difference between arms we might actually get some numbers.
The K trial is going swimmingly. I posted this last month and will so again..Harvard would not take this K trial to cohort 8 if there was nothing there. They surely wouldn't put patients stage 4 terminally ill patients with no other treatment options through all that nor waste their own time on it. K already passed its interim report. Look at all these patients that have done multiple cycles..what for the fun of it?
Their is no leaks because this is Harvard and patients that have had their terminal cancer stabilized by Kevetrin are not going to do anything to jeopardize their treatment. This includes informing share holders of their wonderful success story.
The trials length is its success and Leo shouldn't say much until the trial is over. If he was actually giving many of the details so many want I would be nervous that he is covering something up. This is just how clinical trials go....IMO Leo's silence is golden
Staggered start, new or business as usual? Thanks Wild! I wonder if the staggered start in cohort 8 is due to increasing expectations that a SAE can happen at any time and perhaps this started back at cohort 7? It would make sense at the dosage that they may treat one patient one week and start another the following week etc. This can partly explain the length of cohort 7. If your expecting a SAE perhaps you don't start 3 new patients up at that dose at relatively the same time.
Or perhaps its more of the mechanics of things.. random and meaningless. It makes sense too that it would be difficult with this patient population to get 3 patients to start up on a new dose all with in the same week. This might explain every cohort since the very first one.
Even crazier speculation on my part is that with what know there is ample patients waiting to get on board, but perhaps DF is starting to target certain tumor types creating a longer screen time that naturally staggers the start of any cohort.
Just ranting speculation!
But I am fairly certain our pps will start to move up in a week or so in anticipation of B 2p interim report. I see no reason why the content of such would be any different than the interim report from B 2a.
A MONTH OR TWO! Thanks BK
BK, you are referring to PMS (post marketing surveillance) with a phase 4 how do you see play out with a partner?