Apparition, I think this is a very good sign! Despite accelerated enrollment no one saw the need to move up the safety meeting. I am guessing the clinicians are seeing equally fine results across all patients, no interventions needed, no SAE's etc. Originally the studies Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure) it started February 2014. With out the accelerated enrollment the end of June would have been the halfway point in the study.


My past experiences with interim/safety meetings with other small biotechs have not gone well. One trial was stopped after the safety meeting because the cancer drug was somehow being outperformed by placebo, if I recall correctly it was sugar enhanced sgen35. The other co. had liver cancer drug that made it pastthe interim report but the drug ultimately failed miserably.

These events can be huge catalysts but like I said before here in CTIX-land who knows???

STICKY...I think that article should be a sticky. Thanks Amatuer. Leo would love to tell us..but he can't.

Apparition, Leo probably didn't know the exact date at that time but surmised it would be relatively soon. All double-blind studies have to have a independent safety committee. Perhaps at the halfway point but I am not sure its late here I believe because enrollment is ahead of schedule. You can't really have a experimental drug study with humans and not have anyone check in on it.

Me and Sox both brought this up when the PR that Sox posted (Confident in Formidable Antibiotic etc) was released. The 2b study will be unblinded to some extent for the committee to check for any safety concerns. I am not certain how much information (notes) Leo will have but if the safety committee allows the study to continue it will be a good sign.

So the big news from B safety committee meeting we want is that the trial may continue on. If B is not working or shows little efficacy they can stop the trial. I believe they always do this on double blind studies and probably should. If the timing of the meeting seems odd it probably only because enrollment is ahead of schedule and the meeting date was planned before the trial started(etc).

It will be interesting to see what notes the committee give to Leo I believe this independent safety group actually unblind the study to some extent to make sure its worth the effort. If they the say the study can continue it should be a big catalyst but in CTIX land it will probably mean the stock will tank...=-)

A few PR's back Leo actually told us about this interim report.

I think you don't go K cohort 6,7,8 if you don't have something promising when given the secondary objective of the trial is efficacy and its being measured. Harvard wouldn't waste their time on it, company doesn't dump the money on it and you sure as heck don't put terminally ill cancer patients through it if its a dud. This is Harvard after all not your typical CRO that you can pay bonus money to expedite the trial.

And I am sure promising is a understatement. If all that Kevetrin is doing is stabilizing terminally ill stage 4 cancer patients that are drug resistant to all other treatments for their particular type of cancer that is getting a close to a miracle as you can get. Duration of the trial is as amazing as it is frustrating. And all those patients doing multiple cycles..yep.

The only disbelief I have in the above is the companies crappy market cap. But does big money, investors and pharma, really care if they get in with a market cap. of 200M or a 1B or higher? I think not, retail can only take it so high and there will be plenty of room when all things are validated.

The only concern I have is if this soon to be rocket impacts the moon knocking it out of orbit or worst yet it shatters the moon and we all get pummeled to death by falling debris. The ultimate irony.. Murphy's Law of Curing Cancer!

Just Rant'n
Have a good night all!

DOH! Thanks KM! I am still angry though I shall have to go vent on a hapless employee =-)!

Alright, who was is it that tried to correct ~last month when I said B trial isn't truly blind because B is not placebo'd out to 7 days like Dapto?? Only 1 of the 3 arms has placebo till day 7 the low single dose, minus the comparator arm. The high single day dose and 3 day low dose do not have filler placebo to 7 days.

If the company say Brilacidin is doing well it because they know it! In case there is anyone out there in this trial if you had only a single or 3 day dose you were on Brilacidin and let me know how that went for you? No SAE's to date no information on intervention treatment??? All we have to do is land in a 10% margin. B is looking rock solid!


Experimental: Low Single Dose Brilacidin
0.6mg/kg Brilacidin IV (single dose) on Day 1, followed by placebo Daily Days 2-7

Experimental: High Single Dose Brilacidin
0.8mg/kg Brilacidin IV (single dose)

Experimental: 3-Day Regimen Brilacidin
0.6mg/kg Brilacidin IV on Day 1, followed by 0.3mg/kg Brilacidin IV on Days 2 & 3

Active Comparator: Standard dosing regimen Daptomycin 4mg/kg Daptomycin IV daily for 7 Days

https://clinicaltrials.gov/ct2/show/NCT02052388?term=cellceutix&rank=3

Oddone, I come up with 63 days left of enrollment so yeah ~early August. If only we can do such a thing... 1st patient treated ~Feb 25th at 60% on June 2 roughly 1.23 patients a day. They have primary completion in October listed on the gov site. The CRO for this eStudy will be a paid a bonus if they complete enrollment early. Looks like they will be handing out bonus checks!

DF needs to publish and probably doesn't want to do so until they have a complete data set.

The company PRd their thoughts on B's competition on April 1st. Advantage B. B is administer via IV. But I don't see need to elaborate on a subject that Jerry brought up does anyone else?

Shin, the most interesting part to me is that reward is for a phase 2 trial. Regardless of the particular company. How would this fit with a antifungal that likely preclinical still?

Nice find Shin, a lot matches between your links

Wild that is a good one. Foxworthy used to go on the road with a fellow comedian Ron White. I went to see Ron live here in Seattle let met tell you that was some of the most raunchy and vulgar jokes I ever heard. He really had to "Disney" himself up when he was on the blue-collar tour.

In the words of Jeff Foxworthy..If you didn't like today's PR you might be a flipping swinger. Along those lines, why do all of my salad bowls say Cool Whip on it?

Perceived benefit we have that and it has nothing to do with dose-escalation. The brave souls that have undergone multiple cycles have to have a perceived benefit. If not their job is done. K at whatever dose they were at initially, is safe...job done right..wrong most have gone on to undergo multiple cycles, why?! And yep they are stage 4 terminally ill patients resistant to all other treatment they undertook thus far. This group is also our greatest clue to what is going on: From Jan. 15th (wish Leo would give us an update on this)

To date, one patient has competed 7 dosing cycles; 2 patients have completed 5 dosing cycles; 1 patient has completed 4 dosing cycles; 1 patient has completed 3 dosing cycles; 8 patients have completed 2 dosing cycles; and 7 patients have completed 1 dosing cycle. A dosing cycle is 28 days. - See more at: http://cellceutix.com/cellceutix-provides-updates-on-clinical-trials-and-developments-of-its-anti-cancer-anti-psoriasis-and-antibiotic-compounds/#sthash.GSpTXAhx.dpuf

That is 13/20 which would actually be 13/17 because the last cohort would not have had a chance yet to even start a new cycle, the data was at the close of cohort 6. So 13/17 patient have had a perceived benefit...pretty good!

It "feels" like a DLT will come soon here and 165 will be our MTD.

AND IMO TO ALL OF THAT

A lot of patents list kevetrin as a HDAC2 inhibitor. Celgene is one of many...
https://www.google.com/?tbm=pts&hl=en#hl=en&q=hdac2+inhibitors+kevetrin&safe=active&tbm=pts

If we go by head counts here Infinity Pharmaceuticals is our new partner =-)

I agree George, I think its a good idea for Leo and Dr. Menon to attend ASCO ...to stay in the mix.

Thanks ETL, I am glad they are not presenting at ASCO this year. It would be like putting a black box in side a black box.

Thanks Sox, I didn't know B-OM was presented before. I would rather have Leo spending his time with big pharma as well given the circumstances.

I didn't get a response from Leo on my email. I posted the email I sent but that didn't include the title which was "WHAT THE HXLL HAPPENED TO COHORT 7!" regrets there =-)





"B-OM was presented by PolyMedix at the 2012 ASCO, so there is really nothing new for CTIX to present this year. I would rather Leo use the time to present at another big pharma next week LOL."

I thought the only reason to pay attention to ASCO this year was on the remote chance of some big pharma announcing a combination trial with Kevetrin?

I don't know much but if CTIX was presenting I am sure Leo would have PR'd that long ago. They don't even have anything to present because they already did "trial in progress" I don't believe there is a category for "trial still in progress". The only other option would be B-OM but like I said Leo would have made us aware of it.

The thought did cross my mind that the company might have some good news to PR after ASCO since they weren't able to present at ASCO, if if if they had something good-great to PR Monday might be a good time to do it.

Just rant'n

Here is the email I just sent....

Hello Mr. Leo Ehrlich, my name is David a long time shareholder and fan of your company. First off I would like to thank you and the team for all your hard work. Its truly amazing how quickly you turned around the Polymedix assets I can't believe we are half way through Brilacidin 2b already.

But I was curious about the seemingly extended time that Kevetrin cohort 7 is taking. Can you make any comments to shareholders on this subject? Are patients still dosing in cohort 7?


Be well, Dave

Dare I say it...Email campaign! If you want to know what happened to cohort 7... ask the Leo. If you want to know what happened to cohort 7... ask the Leo. If your curious and you know it your face will surely show it. If you want to know what happened to cohort 7 ask the Leo, ....ask the Leo!

I am going to fire off an email to Leo with the before mentioned subject. Any other brave souls want to follow me in to Battle!

And clap your hands =-)

LOL, my phone is absolute worse with the auto-correct and my giant monster-like hands only exasperate it. That why most of my posts don't make any sense but darn it I spent 5 minutes typing it out so I am going to post it anyways!

Wow Alex, I am getting a little jacked up now that updated and used bold print! I believe Dr. Ready's is actually Dr. Reddy's. Thanks!

Apparition, LOL me too there is no way I am going to try to read that thing after midnight.

BK, I should mentioned how big that list was but yeah kind of neat that MIT knows of Kevetrin.

Here is patent from MIT published just this month that includes Kevetrin in search. Now there is a lot of big fancy words in there that I don't understand and I hardly read any of it but apparently it wants to patent Kevetrin and many other compounds with virus-specific T cells. The T cells could deliver (payload) Kevetrin to specific locations in the body.

https://www.google.com/patents/WO2014074952A1?cl=en&dq=kevetrin+-cellceutix&hl=en&sa=X&ei=ysiGU9GDG83YoATx8IGoBw&ved=0CDwQ6AEwAQ

Ultimate I remember a few years back where there was one day of ~3500 volume and the next day ~0. I bought the 3500 and was going to buy more the next day but got too busy. =-)

NR, I think that fact will start to get interesting if only we string along a few days of similar action (or non-action).

I am liking thiss volume right now. Holding for news? Aspire is off the clock. I think when we get cohort 7 news it seem mundane compared to some of the hype lately but making it in to cohort 8 will be huge. Aguranteed dose of 165 or better.

Aspire hasn't had to file S3 yet. Aspire is selling IMO

Great PR this morning! The CTIX team went off to give a formal "sales pitch" to one of the biggest pharma. The odds of us having a partner after B 2b just increased and it sounds like the whole platform could go! I am a bit surprised that the rest of the old Poly pipeline is drawing such attention.

New Jersey that sounds like Princeton! I believe they do a lot of work for the NIH and likely have a big influence on them.

Its remote but possible IMO

Well this is how we get to 65,000+ posts..endless speculation about what is going on..Celgene partner-sure, PFE buyout-great, cohort 7 started when?, Brilacidin cures baldness-then, prurisol POC, trial results trump all, swingers kick'in footballs.."its the end of the world as we know it... and I feel'in fine!"

No one is right and no one is wrong at least not yet. Speculate away I say.. I am personally working on crazy theory 2xx it involves Dr. Menon and some nude mice, were talking scandal that will light the fire on this rocket..

=-)

Well if you pretreat with k perhaps they won't be resistant? That PR opens many options IMO..nice find I didn't recognize the other name. Was that intentional by the company?

So Dr.Jerry that is the insider information from MD Anderson? I see celgene is presenting at ASCO on your favorite compound do you think they will be revealing any of this info there?

If you feel like your losing a a little faith in Kevetrin due to the duration of cohort 7 it might help to go back and listen to the presentation given at the Biotech Showcase this last January when cohort 6 had just finished. I highly recommend the audio clip from 4 to 7 minutes or the whole thing.

http://cellceutix.com/events/#sthash.Dkoc5Yem.JcCSmuQf.dpbs

KEEP THE FAITH!

Whoops I looked at the price and volume today. Looks like we are filling out new bottom. Flipping swingers activate "form of a" buyer. Pennies await you!

MD Anderson and they are doing preclinical work on kevetrin right now.

My crazy theory #1xx is for pooh-poohers of PRs like the one we had today. You know the PR's that announce yet another possible indication for Brilacidin. What if CTIX is exploring Brilacidin so intensely; OM, ocular, otic, DFI and whatever else because they hope to partner-out Brilacidin (after ABSSSI) for all indications? If your going to do this you need to know what all is possible/what the drug is possibly worth?

Glad to hear where B-OM is at...and my joke for the day is..we might get a update on Kevetrin cohort 1 AML UofB p1b before we get a update on cohort 7 Kevetrin p1 solid tumors....hahaha....wait...ouch