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JnJ was first company of thought of when implanted devices were brought up mainly due to DePuy which JnJ acquired back in 1998. I have some of their parts in my knee now.
Wow, the company has so much going on its hard to keep track of it all. This is not indicative with a company with just over a 300 million market cap something has to change there. Hopefully, Leo has more than one cell phone.
The prophylactic use of Brilacidin is something I have been hoping for ever since I heard about polycide. I am guessing its the same big pharma that the company gave the presentation to a few months back. Kevetrin cohort 10 I wasn't expecting that till next year.
So many catalysts in December and going in to next year amazing! Big one for me is probably the FDA meeting about Brilacidin p2b in the near term. Need to get a feel for the FDA response to Brilacidin, fast-track etc before we start partnering talks.
Have fun all!
Yep, 3 for 3 so far. Brilacidin a very successful p 2b. Kevetrin p1 great! Prurisol looks good in the crossover. All with future trials in the hopper. The day to day pps is irrelevant to me at this point.
"Shorts=Flippers" I don't think CTIX has much short interest. Leo just doesn't want to offend his "base" investors too much... =-)
Thanks 58, you too.
58, to each his own.
Oh wow, thanks Gov I have been wondering about that for awhile now.
BK, possible preliminary report on K? Take it easy on me now I might have a heart condition =-) Ya never know.
I always wondered who knew about the Polymed bankruptcy that allowed CTIX to purchase it 4.8 million? Dr. M and Leo are smart fellows but I don't believe they have a background in antibiotics and were perhaps unaware of Polymed? If they didn't already know about the company I would guess I would go with either Dr. M or Leo's sons since they have their own company in antibiotic research. What a steal!
58 I was invested in seattle genetics when the company didn't a private placement with the Baker Bros. at $16 a share and were given a board seat. Its not selling out its just good business. SGEN has a 4.5 billion market cap. and having either one the Bakers on your board enhances your BoD their experience is worth it. IMO
ETL, I am very excited about uplisting. Are the big boys there and waiting and perhaps more important to what degree? I personally have friends that will not invest in any OTC. I feel I am jumping up and down in front of them like a 5 year old boy with a sugar high telling them about company developments and they are sitting their calmly telling me not until the company grows up or perhaps they are saying not until you grow up either way just buy the darn stock already! I have came to the conclusion they would rather buy it at $10+ on a senior exchange than $3 on the OTC.
Hey Chem, safety for Brilacidin was already established in phase 1 trial. Brilacidin and Brilacidin-OM are the same drug. All the future Brilacidin trials should also start out in phase 2 where dose optimization is the objective.
Gov I am torn between lets see what we got and lets get another dose increase in K p1. Would love to see the graph of dose versus p21 levels. The slope of line in particular, is it just getting started on a sharp rise or starting to flatten out at higher doses etc. It will be what it will be but that big dose increase between cohorts 8 and 9 with now one DLT in 9. Management and Harvard are tops I am sure they will get it right.
Just very happy to see the company PRing some news on Kevetrin!
Over the next six weeks we have:
Start of the B-OM trial at MD Anderson
Start of K in AML at UofB
Bottom line B 2b results with FDA comments which could be huge!!
Prurisol FDA meeting
And just because of the last PR perhaps even more information on Kevetrin solid tumors p1????
Uplisting???
Anything else? Not sure what the share price will be but the entertainment value is going off the charts for me.
For the Bakers, private placement sell of 10-20 million shares at current market prices of course and a seat on the board.
I like the plan for the company to hold B 2b ABSSSI results till after they meet with the FDA with in the next 6 weeks. Announce great results with breakthrough/fast-track designation from the FDA it could be Da'Bomb we have been looking for. This and other catalysts we have coming up should keep the buying pressure on from here to there.
The company may not want to have any serious talks with potential partners until that FDA meeting so hold the data.
Sox, I was hoping for a tidbit on AML UofB as well. I cannot complain though a lot information released today including Kevetrin! If we excluded the lower dose p21 tests I wonder what the percentage would be?
Did anyone take a whack at the meaning of this "We believe we are nearing the conclusion of this first Kevetrin trial, but we still have some decisions to make, which could include another cohort to confirm our findings on Kevetrin and assist in planning for future studies."
Sounds like we might be seeking some pancreatic and perhaps ovarian cancer patients?
Good times...I will try to catch up all the posts today
- See more at: http://cellceutix.com/patient-enrollment-in-cellceutix-phase-2-clinical-trial-of-brilacidin-om-for-oral-mucositis-targeted-to-begin-in-december-2014/#sthash.XesKuASW.CxrSkNvo.dpuf
Thanks everyone for the great comments today. I am just now finding time to actually read the PR, 10q and golly an amended s-3.
CTIX just cannot win for many of our current investors. All the preliminary data we have seen from the Kevetrin phase 1 trial has looked great to me. But a lot of investors just don't recognize it unless the stock goes surging up. They don't seem to be able to interrupt the news themselves and only recognize it as a success or failure based on the pps movement. To me the chance of a miracle gets brighter with every tidbit we get to them the light diminishes everyday.
I am still flipping my lid over Brilacidin 1-day treatment for ABSSSI. I have been on a lot of antibiotics in my 39 years. Never has it been for just one day and never has it been for something as serious as ABSSSI. Truly a game changer in progress and while the stock doubled in 2 months some investors say is that all? Or their must be something wrong with the numbers? And sell.
The company announces a shelf offering and I think "Welcome to the Big Leagues" and others say its a curse word and sell. In their view while they were vested in CTIX wouldn't the Aspire deal equal pure blasphemy.
Right now we are dominated retail flippers studying charts instead of interrupting news and low-brow MM's that work the OTC. That is why I am very excited about uplisting and drawing the attention of those how can interrupt the information other than the stock chart.
And all of that of course is IMO
Fanfoiz, we were sitting at a ~$1.70 and drove all the way up to ~3.40 first on anticipation and finally getting top line results. The bottom line report is due anytime. So we doubled in quick order and the interesting news on B 2b is still yet to come. After a doubling the share price I think a small pullback is in order. All in all I don't think the company will spend too many trading days in the 2's. IMO
Apparition, we will turn green tomorrow. Swingers can't lay off the possibility of a Monday PR, especially, one that might include B 2b results.
Well said Ro
Don't let them fool you. Bottom line results on a game changing antibiotic anytime. This one can just as easily go over $4 as it has under $3. Flipper hypertension shall wane.
Sold a rental last month funds are in at the broker I am a buyer on my next work break. Feeling kind of lucky on this pullback here.
EAT YOUR BROCCOLI! Were moving up.
Anyone want to weigh in on efficacy with Brilacidin 2b bottom line results and its effect on the price per share? Looking at the phase 2a (link below) I am guesstimating that the better of the two 1 day treatments will be in the low 90's for 28 day sustained response. I think 90-93% will be par for the course and confirmation of results will drive us up to $4.00. Anything in the 94-96% range being above expectations pushing us closer to $5 and anything over 96% being well beyond expectations taking us to???
I don't believe any of Brilacidins short treatments will reach Dapto at ~98% nor does need to. We will get the bottom line data in the coming weeks but I was curious what others are expecting...market expectations perhaps not so much on pps but on efficacy?
EAT YOUR BROCCOLI!
http://files.shareholder.com/downloads/ABEA-4ITCYZ/1997024712x0x611205/FEA66C67-D02F-4FF2-B230-AA711F46ED7F/PMX-30063_Antibiotic_Fact_Sheet_Nov_2012_.pdf
Lousy Engineer, the 75 million is just a number they are not going to dump all those shares on to the market at one time and I doubt they will have to dilute that far. Its just gives them room. They don't have anything budgeted out for that amount.
So this secondary is essentially timed to the release of B 2b bottom line data release which is very standard practice for small biotechs which is to raise funds when you can. This should give Leo more control over the stock price controlling when and how much dilution occurs. Rather than giving discounts and not controlling when the shares enter the market..aka Aspire financing.
Should be less dilution...more control..sounds good
Bottom line results on B 2b in a few weeks according to s-3. Many apologies I didn't take note on what page that was on. I believe their is something more to this shelf offering than just simply raising funds. Unless they just simply did not like the Aspire deal, which seemed likes a very good deal. They still have a lot of room to raise funds under their current agreement with Aspire perhaps even enough room to already run a B phase 3 especially if they reach some type of arrangement with the FDA.
Top Ten deadliest cancers
http://www.nbcnews.com/id/39102353/ns/health-cancer/t/top-deadliest-cancers-why-theres-no-cure/#.VFGnlvnF9qU
If Kevetrin can get any kind of traction on these in phase 1 in stage 4 patients! I always heard pancreatic and colon were the worst if you got them.
So much potential news here now a days. Who knows we might get a partnership with K before B. Be bought out etc. I am still waiting for the former PolyCide Antimicrobial line of products to be announced! We just need a new name for the product?
JUST, I am probably the worst person to take a swing at this but swing I will...
Uplisting: will bring us up over 5.00 expecting that to happen with in 3 months. We should start moving up to 4.00 soon here after we clear out the trash. Kevetrin at UofB will help here.
Brilacidin bottom line data ~4 months will bring us up to 6.00-8.00
Followed shortly by partnership announcement that will take us to 9.00-12.00 or higher depending on the deal.
The company has so much going on that developments could rise at any time to get us there quicker. But I will go with March 23 and will be battling in the double digits.
I am absolutely certain this will be wrong =-)
TP53 gene encodes (makes) p53 mind you we are talking about an individual cell here. Without the gene there is no way for that cell to make p53 in the cell. If Kevetrin is only restoring the pathway from the gene to production of p53 that would mean the gene was never mutated and just blocked. Just restoring the pathway would not be sufficient to produce p53 if the gene is mutated it would have to know how to make it. I would consider restoration of the pathway to a functional gene to be gene therapy as well because it would be literally turning the gene on and off at least in terms of p53 production.
The effect of p53 has to be localized for efficient tumor cell suppression. Big pharma a decade or so ago tried flushing cancer patients with the p53 protein but it quickly became to toxic without much in the way of tumor suppression the attempt here is to get the individual cells to produce p53. I mention this Just in case Kevetrin is simulating p53 itself.
The FDA's definition of Gene therapy: Gene therapy is a medical intervention based on modification of the genetic material of living cells.
Genetic material: The genetic material of a cell or an organism refers to those materials found in the nucleus, mitochondria and cytoplasm, which play a fundamental role in determining the structure and nature of cell substances, and capable of self-propagating and variation.
The TP53 gene, the MDM2 pathway and p53 protein are in the nucleus, through the nuclear envelope and in to the cytoplasm.
I don't care to nit-pick about what Gene therapy is...but I would caution you about announcing that you know the method of action (MOA) of Kevetrin. I am not even sure Dr. Menon knows all those details yet.
Kevetrin doesn't really activate the TP53 gene, rather the gene product p53 (protein of 53 kDa size), via multiple mechanisms. We are not modifying any genes.
Gene therapy would be, as you said, insertion or knockout of genes, or modification of (mutated) genes. Human clinical trials for gene therapy have to go through additional precautions, such as staggered starts, the recombinant DNA advisory committee, and other.
http://osp.od.nih.gov/office-biotechnology-activities/biomedical-technology-assessment/hgt/rac
Gene therapy companies include: SGMO, BLUE, KITE, etc... but not CTIX. Here is a list of all the Gene Therapy trials that have occurred in the US:
http://osp.od.nih.gov/sites/default/files/resources/PROTOCOL_0.pdf
Thanks BK, the bear is in the details of the MOA. If the p53 protein is being produced because of the reactivation of the TP53 gene its gene therapy in my book. If the MOA is as the company describes its gene therapy. I think some might be put off by this because the company has not used the phrase to describe Kevetrin and associate gene therapy as being highly experimental or controversial even if in vitro.
The staggered administration is in part due to first in human but its potential to be genotoxic has to be a factor too...
On the genotoxic part I wanted to ask you this... the pk/pd data may or may not be able to cover all safety concerns that come with a drug that is potentially genotoxic??
Thanks!
KMBJN, the point was first in human for the staggered administration. Interesting thought though is reactivation of the TP53 gene is not gene therapy? I suppose the trendy/futuristic thought would limit gene therapy to insertion/addition of genes to prevent disease. Or perhaps knocking out a gene that is mutated. I am just happy Kevetrin doesn't appear to be genotoxic.
Please elaborate more on why the reactivation of a gene is not gene therapy? Just curious..
The Nasdaq requires "$3/share price — for at least five consecutive business days prior to approval, the security has a minimum closing price of at least $3 per" I would assume the other markets are similar.
Where do you find the pps must be over $3.0 for 60 days? For NYSE?
NASDAQ article link
http://www.theventurealley.com/post/
Staggering Administration, all the cohorts in K p1 will take at least 7 weeks then add in the safety review and the timing of when the company informs us. Two months is about as quick as it can go per cohort. First in human rules for cellular and gene therapy.
"When there is no previous human experience with a specific dose, treating several subjects simultaneously with that dose may represent an unreasonable risk. To address this issue, most first-in-human trials of CGT products include staggered treatment to limit the number of subjects who might be exposed to an unanticipated safety risk."
On page 12 here:
http://www.fda.gov/downloads/Biologi.../UCM359073.pdf
Excellent point, FM
Doug, this is the type of OM related to treatment of head and neck cancer patients. Very severe ulcerations with few treatment options that is why the company is using placebo in the trial. Its not your typical OM.
With the success of B ABSSSI everything B is starting to take on a gold tint! BK's numbers on the whole B platform might come in to play in partnering talks.
Y'all have a great weekend
If there is no other effective treatment for oral mucositis one could perhaps charge whatever they wanted.