Way out here in south Alaska -Seattle we don't here much about this QB Manning much is it his brother that is good one? This one just seems to talk a lot at the line.

Actually, Sox's sticky above from Patrick Cox under "PolyMedix throws in the towel" gives better commentary on the subject. Apparently B 2a trial results were not well known, there was fear of a rare condition brought up in that trial and they just had a big trial failure with D. Burn'n cash and someone called in their debt and they folded.

If you look back at the posts from last September when the deal was announced there was a few people posting here on this board that were former PMXY shareholders. Generally, they were shocked that the company just collapsed so suddenly with apparently such a promising future/pipeline.

To me, the shock was not that PMXY went under but rather that CTIX was able to pick up the assets at such a price. But essentially with no one to answer to besides themselves Leo and Dr. M could "nimbly" maneuver themselves to get the assets.

Here is the Fierce Biotech quick summation: http://www.fiercebiotech.com/story/polymedix-defaults-and-hands-over-phii-antibiotic-bankruptcy-court/2013-04-02

I got your back TD, purchased $20 worth of mints from the girl scouts huddled outside of Fred Meyers this morning. The benefit was actually 3 fold..1 My 6 year old boy apparently "favored" one of the girl scouts, 2. I always buy some for support and 3. TD said so!

I gave my son $20 and told him to go buy some cookies but be sure to get some mints, my favorite. So he went, talked a lot to them and got 20 bucks worth of mints and a play date with a 12 year old girl..so he says???

Good times..thanks TD

Come on Leo with B p2b start!

Here is the Google patent search for Kevetrin minus Cellceutixs patents. Amgen, ?Global Bio Therapeutics , ?Infinity Pharmaceuticals, ?Pharmacyclics and various universities.

Mr. The Progressive who pioneered patent searches for Kevetrin =-) also listed Iris Pharma but I have not been able to find that one yet..

https://www.google.com/search?tbo=p&tbm=pts&hl=en&q=kevetrin+-Dr.+-Menon&num=10

Anyone curious here is the list of sub-investigators working on K p1 and their field. Is there anyone new to the list???


Sub-Investigator: James W Mier, MD Kidney Cancer and Cutaneous Oncology and Melanoma

Sub-Investigator: James Cleary, MD Early Drug Development Center
Gastrointestinal Cancer

Sub-Investigator: Sara Tolaney, MD Breast Oncology

Sub-Investigator: Nicole Chau, MD Head and Neck Cancer

Sub-Investigator: Leena Gandhi, MD Thoracic Oncology

Sub-Investigator: John Hilton, MD Early Drug Development Center

Sub-Investigator: Andrea Bullock, MD Gastrointestinal Malignancies

Sub-Investigator: James Butrynski, MD Sarcoma

Sub-Investigator: Jason Luke, MD Malignant Melanoma

And of course the big dog!

Investigator: Geoffrey Shapiro Director, Early Drug Development Center

Canes, if I recall correctly Dana-Farber Harvard pioneered cancer tumor mapping and is one of the reason that Cellceutix wanted the Kevetrin phase 1 study done there.

"Dana-Farber’s extensive tumor mapping technologies will help us pinpoint which patients will benefit the most from Kevetrin as we move towards defining the Maximum Tolerated Dose."

Link: http://cellceutix.com/cellceutix-presents-poster-at-asco-on-its-clinical-trial-of-anti-cancer-drug-kevetrin/

Gov and JB that is a valid point but I think the objective K p1 beyond MTD is to verify the method of action of Kevetrin. This makes K p1 more of a home run swing if Kevetrin is re-establishing the MDM2-TP53 pathway it should be effective in all the cancers that have this degraded pathway.

Leo also stated that they would use DF tumor mapping technology in the end to see where K would be most effective going forward. The blanket approach of K p1 probably means that K will be in numerous advanced trials if all goes well. Retinoblastoma in children is a nice target from the humanitarian side but also the orphan/fast track/approval scenario other cancer targets may well be dictated by big pharma in partnerships after p1.

BK listed a scenario I would love to see. If K p1 shows effective shrinkage in numerous tumor types they fast-track it up to a phase 4 solid tumor treating the same patient population eventually you will get an adequate sample size for each tumor type. BK forgive if I stated that wrong!

In short, I believe K p1 is not targeting any particular cancers but establishing the MOA. If the MOA is right OMG =-)

The longer the K trial goes the better. Worse case scenario now is DLT in C7 and we are back to 110 for MTD. With signs of shrinkage at 75 or less and combo therapy at lower doses we are being de-risked daily. But of course it does not look like anyone is expecting any kind of actual DLT soon. Wonder if the first patient in C7 has received a 165 dose yet? One would think if there was any issues with the 165 level it would show up early.

I am expecting a PR soon with the start up B p2b and a follow-up on P. Not following the price action too much now just following the story!




"Very exciting if they not reach MTD at 165 this phase too. Bundle of news could be released monday, this probably would be at 2.00 today if not for the overall market."

And Gov, we are about to get a lot of multicycle patients being treated at the 110 level..very exciting!

I like the fact that we have the higher dose single and the 3 day dose regime as backup, if you will. Cox did a great job in explaining how important a single dose antibiotic could be. In my own personal experience with antibiotics mainly amoxicillin for ear infections it is usually a 10 day course and only in days 8-10 does the antibiotic actually clear things up. A one day treatment especially given that it is administered via IV should be a significant market advantage.

Has anyone else got the feeling that there has been an acceleration in the number of treatment cycles from the RR to the Biotech conference?

From RR September 9, 2013:
Completed 4 cohorts
1 subject completed 7 cycles, 1 completed 4 cycles

Also for fun:
Evidence of stable disease by radiological examination in 6 cases.

From the last update Jan 15, 2014:
To date, six cohorts have completed enrollment.
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.

Also for fun:
Tumor shrinkage

We are limited by the lack of details from the RR conference on the total no# of cycles. I think Leo just gave the top two no# of cycles at that time.

There is a few things to poke at here:

The 7 cycle patient has not yet completed another cycle

The patient with 4 cycles and presumably had stable disease from RR has or has not completed another cycle but there is now 2 patients at 5 cycles and one at 4 cycles.

Most patients have had multiples cycles especially if you consider at least 3 patients form cohort 6 have not yet had a chance to take multiple cycles plus those that had to drop from the study ~2 or more.

This would roughly give us an average of 3 cycles per patient in a study where getting one cycle complete can be difficult.

Sorry for the rant, I am sitting out a flight delay back to Seattle and there is Starbucks right next to me so I got my buzz-on but that is impressive average of cycles. There is probably too many unknowns in this comparison between the two conferences but I think someone has been saying "More K Please!"

What I don't understand from some posters here is there disappoint in regards to updates for Kevetrin during Biotech showcase conference (conference + PR)?

They gave us:
All the patients and completed number of treatment cycles.
Informed us that there is now evidence of tumor shrinkage.
Explained in detail the reason for the protocol amendment.
Announced the start of cohort 7 along with dose.

The only thing missing was p21 but I will take tumor shrinkage in lieu of p21 for now. They actually PRd the list of patients and cycles! -NEW strategy? Shrinkage-New development! Since the company was able to publicly comment on these items now they maybe able to comment on them again in the future..ie DF disclosure issues...

The only reason I can think of that some people were disappointed is that Leo didn't come out announce all shareholders to be millionaires now!

What I posted contained little speculation and your right it does sound "peachy keen". I believe most people don't realize how early they are in investing in this stock, have too little patience for a young biotech and don't realize how long the clinical trial process takes. Having said that I would not be surprised if I woke up tomorrow and the stock is trading over 10. I think we are close to institutional investment, analyst coverage and higher share prices. But by close I mean months not days nor weeks.

Right now the stock is still dominated by retail flipping swingers, the penny stock crowd that sell anything over 2 (currently) regardless of the news in fact I don't think they understand the news. This is indicative of how young this company is but these flippers will be swept away soon and go back to there penny stocks. This should only require patience.

SHHH, this is our little secret. Kevetrin that has the potential to treat more than 1/2 the known cancers is by all indications doing exactly what it did in animal models, actually from what we know it might be doing a little "better" than it did in animal models. If your not familiar with the tremendous success K had in every cancer it was tested in please look at the company website. In humans we started with tumor stabilization and signs of p21 at very low doses. Now we have tumor shrinkage again still at low doses. The dose is still increasing. And yes this is all going on with terminally ill stage 4 cancer patients that are drug resistant. The repeated cycles 7,5, etc is not only testament to the low-toxicity of K but at some point we are going to have to say its what been keeping them alive. In own experience with friends and family diagnosed with stage 4 cancers they only have 3-4 months to live, obvisously this varies. Seven cycles of treatments is at least 7 months of life.

I am personally excited for the start of the Kevetrin in combination with Cytarabine for Acute Myelogenous Leukemia at U of B. Leukemia is a different beast than solid tumors. K will be hitting/circulating in the bloodstream interacting with cancers cell in quick fashion presumably at higher doses than K did in solid tumors. I am particularly interested in the K alone arm of the study..we may not need Cytarabine.

The polymedix deal at ~$5 million was a absolute steal. Sixteen compounds but if you just look at Brilacidin and just in ABSSSI the short course treatment could be a huge market advantage in the intravenous application. We got the GAIN ACT and B-OM for orphan status and all the rest.

Prurisol has been a bit slow but should be in advanced trials 2/3 this year. The oral application of the drug should be beneficial.

There are billion dollar companies that have one promising drug that fails in comparison to all that CTIX has. With a market cap. of ~200 million THIS IS OUR LITTLE SECRET!

I enjoy reading this board. For the most part there is no where else to go online to talk about this company. But the constant "pissing and moaning" posts about share price is useless and frankly annoying. May I suggest getting a non-cyber shrink or better yet follow the story and not the price?

Just Rant'n

Thank you Mr.NR

Sounds like the Renal cancer study at BIDMC is a go!

First stability now regression, K is doing just fine. The audio replay is back up now if anyone wants to listen again.

What no Q&A time?

Sounds like they will post the slide show at some point. Talking about B in OM now.

That was emphasized perhaps literally they are "Staying Alive!" unfortunately probably not easy for drug resistant terminal cancer patients. If K can do this here imagine what it could do with non-terminal patients!

And he just said it again!

I would wait till after the actual conference before you flipping swingers start selling. Applicable to those of you that are flipping swingers.

Remain optimistic BK! If we can get some new investors here we can sweep out a lot of the trash and they can go back to their "penny stocks" flipping on the dime. Normally, I take my cans out to the curb on Friday mornings perhaps the garbage man will come early this week?

If it does not matter now, it will eventually.

Here is what I think. As investors we focus way to much on share price and expect things to be way more "leaky" then they really are for CTIX. All the years I have been invested here I cannot enumerate all the non-disclosure agreements but there has been a lot and I am comfortable in saying most with Kevetrin. We hear about most combination trials that are sponsored by Universities but at some point (MTD, higher dose) we are going to get a plethora of combination trials announced with big pharma and pharmas many of us have never heard of.

Investors are also underestimating how incredible it is that a p53 reactivating drug has successfully gone this far in dosing and apparent proof of the reestablishment of the MDM2/P53 pathway this will be a major medical breakthrough! This is/will be huge news..the p21 confirmation that we are about to get at the conference.

Thanks to the link Sox posted I found out that ~80% of all cancers have "issues" with the MDM2/P53 pathway. OMG... Kevetrin may eventually be the cancer drug for nearly all cancers. I also think p1 Kevetrin is going to come to a close soon. I think the amendment to the protocol is an attempt to "squeeze-out" the highest dose possible because they have already seen great success.


People have been posting warnings about not getting to over excited about the upcoming conference in fear of disappointment. Long is long, if I am disappointed its ok I will not freak out and sale, its fun to get excited!

Just ranting here of course, but don't let our current market cap. fool ya

Did anyone think about why Leo is giving us a comprehensive update at the time of the conference? Why not give it to us at the end of the year, like usual? The pps goes green tomorrow and I think you a fool if u know of this company and are not fully invested at this point and time.

RR-style, very exciting!

Not a terrific PR. Prurisol crossover p1 will not be starting in January and overall will be taking long than thought. Would need IRB approval than at least 30 days for IND.

Good news is that Leo said "Cellceutix will be providing a comprehensive update on all of its pipeline developments at the Biotech Showcase 2014 conference being held in San Francisco, California, January 13-15."

COMPREHENSIVE!

Gov, if you look at the wording from that PR especially Leo's use of "furthermore" it does sound to me that cohort 7 dosing is not dependent on any amendment to the FDA. If so, a lack of a PR stating the start of cohort 7 and its dose level is a bit odd if the committee met in mid-December, excerpt below.

One thing I was thinking about is that the amendment to the protocol might compel the FDA to review information on Kevetrin to date. The FDA I am sure is busy and has not been "poking their heads" in to the Kevetrin trial until the protocol amendment was made.


"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. Maximum tolerated dose of Kevetrin has not yet been reached. Further, Cellceutix has filed an amendment to the trial protocol with the FDA to limit the dosing duration of Kevetrin to six hours. Cellceutix filed the amendment to keep the dosing time frame within a reasonable number of hours as the dosing level increases as the trial progresses."

Wow Sox, that 2nd video you linked should be a sticky. Thanks for posting that!

Thanks all for the update on the conference!

On the conference did anyone find any clarity on exactly what conference it is? For the JP Morgan 32nd San Fran. website it still says TBA. The other website that list Cellceutix it doesn't appear to be JP Morgan? I was thinking maybe the company that has the website with CTIX listed might be the ones that are hosting the conference for JP??

Moreover, does anyone know if the conference will be presented online?

Sorry missed a lot posts over the holidays..

To anyone who is looking for treatment options for triple negative breast cancer I would encourage them to take a look at Celldex's cdx-011 see link below. This is a targeted antibody based on Seattle Genetics technology. The same technology that produced Adcetris which has been an absolute wonder drug for the cd30 lymphomas.

http://www.marketwatch.com/story/celldex-therapeutics-initiates-metric-an-accelerated-approval-study-of-glembatumumab-vedotin-in-patients-with-triple-negative-breast-cancer-2013-12-02

Not sure your going to get that much of a pull back.

Gov, you are spot with your CE..conformity European
Another possibility to the foreign tax maybe UofB???

LOL, someone might be doing a little fishing this morning. It will be 2.40 not 1.40 in a week.

I hear ya. The first few post I read about this subject had me concerned/confused in many ways. But once I learned it was the children of Leo and Dr. M and has nothing to do with PMXY antibiotic pipeline, I was good. I will have this new company on my watch list and we do need new antibiotics, even with B on the rise, this given the pedigree of the founders might be a interesting company at some point.

Polka it might help if you think more like a parent. Kard is privately held by Dr. M. Apparently his son and Leo's have been working in the lab (at Kard) on antibiotics..their own project if you will. CTIX was never interested in antibiotics as a company until a incredible opportunity came their way in PMXY bankruptcy. These are the children of Leo and Dr. M. I am sure Leo and Dr. M have been mentoring their children in their efforts to create a new antibiotic(s) but as a company CTIX they were not interested until PMXY came along. Makes one wonder if Leo and Dr. M actually heard of PMXY and perhaps even the opportunity there from their children. I think its kind of cool!

Thanks Ovidius for clearing that up!