Chem, increased infusion rate and dose we should be good for cohort 8

Ben, K p1 started 10/22/2012. What year is it? If K is all we hope it is it needs come off a solid p1. Patience grasshopper.

Hey NR, that's cool that your mom posts on here too!

As I remember Leo made the suggestion of biweekly treatment back around ~cohort 3? I wonder what they were seeing way back then that would suggest this, perhaps just confirmation of the clearance times in humans?

Thanks BK! I thought I was getting too excited there.

Gov. could they do that? Take whatever the MTD dose is and give that dose twice a week? I thought they would be conservative and split the MTD dose in half for biweekly treatment. We know Kevetrin has great clearance and if we are getting shrinkage the contents of the tumor would have to be dumped back in to the bloodstream which I assume you would want to be done somewhat slowly and biweekly dose would help with that. But the current trial at DF trial will establish a safe weekly dose? Could the company and Harvard submit paperwork showing the FDA that it would be safe to treat double MTD dose weekly for the advanced trials?

In general terms, I believe terminal diag. is for 6 months or less to live. My father was diag. with terminal liver cancer and he held on for 11 months. My grandfather was diag. with terminal lung cancer and died within 2 months. Yep, here to hoping K kicks some C axx!

Hey VIP, whats the life expectancy of a terminal cancer patient? It depends on the cancer of course and the age of the patient but general definition I believe is 6 months or less.

Since B-OM didn't qualify for OD will they still be able to achieve
"The company is planning a U.S.-based Phase II trial of Brilacidin-OM for this indication and plans an IRB submission at the end of 1Q 2014."

Do they have to re-work the protocol now before IRB submission or just a minor tweek?

Anyone theories on why our 7 cycle patient has not had any further doses from early Sept. 2013 till mid-january? Its suspected that this is the ~82 year old female with clear cell and acheived stability in Sept.

http://cellceutix.com/cellceutix-provides-updates-on-clinical-trials-and-developments-of-its-anti-cancer-anti-psoriasis-and-antibiotic-compounds/


http://cellceutix.com/wp-content/uploads/2012/07/Cellceutix-Rodman-Renshaw-20131-1.pdf

Exactly, how much time do u have with any cancer at stage 4? The number multiple treatments has blasted off from ASCO till September and September till January. K at higher doses appears to be popular!

I would just like to say that I let GOV do all my ongoing DD.

Thanks Gov, that is a good article with lots of links to Big pharma. We don't know what we don't know. Do you have a running count of how many non-disclosure agreements we have?

You would think with the clearance time of K if cohort 7 has had a couple of doses already that a DLT for 7 is unlikely. Bring on 8!

58 thanks for the link!

The B-OM phase 2 IND now is not going to state its just not for Head and Neck cancer patients and that opens the door for all cancer related oral mucositis that occurs. But wouldn't the antibiotic treatment be reserved for the most severe cases, not 2 million patients. Using a antibiotic in the mouth should not be taken likely in fragile patients it could kill off the good with the bad and open your mouth to host of newcomers.

I was reading this article http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1531648/ there is a lot treatments that can be tried before an oral antibiotic is administered.

I am trying to find a number for severe OM cases where an antibiotic rinse maybe applied but no luck and I got to get back to work. If the market for B-OM is what some think it is the company made a mistake in pursuing OD then?

P.S. If the B-OM market is bigger than the B-ABSSSI market I am fine with that...

This is also why I believe Cubist will have to swallow some pride and team up with CTIX for the phase3 trial. Brilacidin is messing with their flagship antibiotic.

CUBICIN Achieves Blockbuster Status with 2013 Worldwide Sales of over $1 Billion.

http://www.cubist.com/news/120-cubist_announces_fourth_quarter_full-year_2013_revenues_provides_pipeline_update

How in the world would B-OM reach these sales? It just barely missed qualifying for OD..small market of head neck cancer patients. There is no competition if B ABSSSI passes 1 or 3 day treatment.

How would a "mouth wash" advance faster than a IV treatment for the skin? Its not easier to measure lesion in the mouth than it is on the skin of your leg?

THERE'S ONE..BURN THE WITCH!...whoops didn't see your smiley there at first. The hunt continues... =-)

TD, I think your onto something there. I think I have enough shares and if I had no life, I am fairly certain I could manipulate the price here. Low volume, 100 share buys and sells a lot of retail low-ball bids and get a feel for the Aspire action..I think it can be done. The April Fools Day joke of changing Investors Hub to Traders Hub is no fools but the truth.

BK, I suppose you have commented on this a million times but looking at the first graph lung carcinoma the tumor volume doesn't seem to decrease much but tumor volume is delayed greatly. Is theory that with multiple cycles lets say at 200 mg/kg that red line is going to laid down flat, it appear to be heading that way?

Three PR's this week? You would think that Leo would have a follow-up on Prurisol, perhaps save it for Monday.

Kind of a unique PR today. Addressing the competition and the shareholders of the distinct advantage Brilacidin may have over two newly approved antibiotics. Also, because B is in a later stage trial it is clear that the company has in mind bringing B to the market.

Maybe its me but I liked the "tone" of this PR.

Soap Opera y'all

Angel, you crack me up. You bash on a company that has 3 drugs in trial. Two that are completely novel with one being studied at Harvard that may become the new base of cancer treatment and a robust pipeline. You bash here while pumping a scam company SB?M. I hope your investment success follows your logic.

Vlady, IMO that is the proper attitude. I simply do not follow the pps, well not directly, unfortunately I check posts here enough and see the pps in the headline of too many posts daily. But generally shrug that off and follow the story here. I am sure you follow the company close enough to know what they have now and what they have before them. All I see is the plot thickening. What the MM's and flipping swingers do now mean little to me they will miss out for the most part when this makes it move.

Weeeeee we are in 3 trials way to go Leo! Three trials in 3 separate fields.

Prurisol start link http://cellceutix.com/cellceutix-initiates-clinical-trial-of-prurisol-as-new-treatment-for-psoriasis/

Sox, my thoughts exactly. It appears to be all about Kevetrin at this point. Prurisol, due to the delays has been a laggard on pps. The market appears to be completely confused about the bankruptcy and assets purchase of Polymedx. CTIX will not credit for the whole thing till Brilacidin 2b is complete and the results correspond to 2a IMO.

LOL, especially if the CRO is near a university/college or a freeway overpass recruitment go be quick.

Sarge, your awesome!

Right so no excuses there

A note on my comments last night. I do not blame CTIX management for all the BS at Harvard. The company handed off this project to Dr. Sharpiro and much like the B trial they have limited interface on the project. If you have read all the PR's and emails its easy, at least for me, to note the growing frustration CTIX is having with them.

I work with research PI's like Sharpiro everyday. If they are interested in a project its full steam ahead they assign their best post-docs to the project and follow it closely. In my view Dr. Sharpiro is not closely following this project, Kevetrin p1 or has too many projects to follow any of them too closely.

Also, their was some comments about money might being an issue here, I don't see. This is the companies flagship compound if their is issues you pull back on the other projects not this one.

HARVARD....YOUR FIRED. If only such a thing can be done with a ongoing trial.

From Dec 09, 2013
"The sixth cohort has completed dosing in the Phase 1 clinical trial" " Further, Cellceutix has filed an amendment to the trial protocol with the FDA to limit the dosing duration of Kevetrin to six hours."
http://cellceutix.com/cellceutix-updates-on-current-status-of-programs/

At an infusion rate of 30 mg/m^2 dosing 165 should not take more than 6 hours. Why stop the trial to wait for FDA approval especially since this is not a safety issue. Why not start cohort 7 back in early December?

From Jan 15, 2014
"To date, six cohorts have completed enrollment, with the sixth cohort receiving infusions at 110 mg/m2. Maximum Tolerated Dose (“MTD”) has still not been reached."
"As disclosed in December (See press release dated December 9, 2013), the Company had filed an amendment with the U.S. Food and Drug Administration (“FDA”) to modify the trial protocol to limit the dosing infusion timeframe to a maximum of six hours, versus the current protocol of 30 mg/m2 without a maximum infusion timeframe."
"The FDA approval now allows for enrollment to begin of the seventh cohort under the amended protocol."
http://cellceutix.com/cellceutix-provides-updates-on-clinical-trials-and-developments-of-its-anti-cancer-anti-psoriasis-and-antibiotic-compounds/

First off, looking at the last quote what logical person would not think cohort 7 started in January? If is was so clear to you in hindsight why weren't posting the last few months "when do you think they will be able to start cohort 7"? For those who made those comments earlier "what you thought it started"...of course most of us did, we were told so. Just because your temporarily long a stock it should not preclude you from logic too.

From today
BEVERLY, MA–(Marketwired – Mar 19, 2014)- Cellceutix Corporation (OTCQB:CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, announces today that the seventh cohort is now in progress in the Company’s ongoing Phase 1 clinical trial of Kevetrin™

Harvard must have freaked out for a few months, thinking OMG we have to do math now! Two months to think about it, really?

If you go back to last year red spot issue. I know safety is job one here and didn't see what they saw. But really red spot at the injection site??? Haven't any of these clinicians had a flu shot before. The delay here was cumulative because it halved our dose for the next cohort.

Then sadly the head of the Harvard molecular testing lab died, sorry to hear this but I tell you what he was not the guy filling the test tubes and performing the tests for p21. While his passing is tragic it should not have been a set back on testing.

HARVARD...YOUR FIRED. To Dr. Sharpiro I am sure you are a busy guy but please start paying attention to Kevetrin phase 1 solid tumors..oh wait your FIRED TOO!

Really? frustrating PR

A couple of days of weak demand/low volume and the MM know they can play some. No worries

Thanks Ovi!

I can go for a little K UofB update.

I'm thinking enrollment update B p2b Monday with a K and P update following.

Woot! Go Gov.!