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That 205% increase did not come from the 750 patient because their cycle is not finished yet, not p21 tested yet. But yeah bring on Kevetrin 1500. Dang I wish we had a graph....dose dependent p21!
Wow, 205% increase in p21 presuming this is at a higher dose. More data please ;)
Who cares about the Russell index I have been waiting for years for this company to uplist. What the index would purchase 1.5-2 million??...meh. The Kevetrin trial is wrapping up, Brilacidin-OM p2 just started, Prurisol p2 within a month and phase 3 Brilacidin ABX. With all the development going on here inclusion in this index is irrelevant...IMO
Never been so excited to be invested in this company than I am right now! I have not posted in a while but have been following all the shorts SA articles and the garbage the flippers come up with on this board and I have to say I have never been more comfortable being overweight in this stock because the arguments against are so laughable. If they really want to freak me out tell me Leo doesn't look sharp in a gold tie.
I sold Jazz pharma at $7.00 because I had ethical issues with using the date-rape drug for sleep disorders its now at ~$172. Had Celldex at $5 and got inpatient and sold its now at ~$28. Cellceutix has more potential than both them combined.
We get uplisted and Wall Street realizes what we have here and sees the development going on and the sky is the limit!
PS.. Expect a company PR in the next day or so about ASCO poster presentation. All the other biotechs in my portfolio announced poster presentations this week so CTIX should be soon.
Yep strong wording.
ASCO abstracts May 13, next Wednesday. Come on Leo fire up that Prurisol trial.
I am not sure what I was just updated on...I know it is an update because it says it in the PR title. I would like to make a request for "additional information" =-)
My wild speculation on that PR is: p21 results are in hand, meeting with FDA for Brilacidin 2b ABSSSI is complete or just a day or two away and the additional board members suggests the comprehensive update will come on the first day we start trading on the NASDAQ.
And with my Carnac the Magnificent "I hold in my hand the envelopes. As a child of four can plainly see, these envelopes have been hermetically sealed. They've been kept in a #2 mayonnaise jar on Funk and Wagnall's back porch since noon today. No one knows the contents of these envelopes, but you, in your borderline divine and mystical way, will ascertain the answers having never before seen the questions."
Answer: With in 7 trading days
Question: When will CTIX be trading on the NASDAQ?
Odd PR. Kind of a mix of we have something really exciting to tell you but we don't have all the information yet but ranging to we are still here. Either way its a green light for the flippers sounds like we are days away from the update.
XOC, this makes sense to me.
BK do you really think that is viable that the company can present Kevetrin again as a work in progress because of a protocol change late in the trial? Mind you its also an upgrade from poster to presentation. Also we were initially informed/hinted of this in the same PR that presented the disappearing spleen lesion.
Dr. Sharpario is a big fish at ASCO is it possible that he got us in under the "holy shxx" category?
=-)
"...cover the protocol, changes to the protocol mid-trial, and rationale for the changes as a summary without breaching guidelines for outcomes and preliminary data for trials in progress. The presentation itself would then be able to include some early data supporting the reasoning for the protocol changes and the outcomes regarding those changes. This could all be done without presenting preliminary data for primary and secondary outcomes." Also, as mentioned in my reply response to TOB, generalities about correlations, but without getting into hard data of preliminary findings.
The good news for longs is that the weak share price should end soon. Leo activated the flippers with this PR:
Cellceutix intends to provide shareholders with a comprehensive update on all clinical trials and development of compounds in the pipeline following the end of the quarter.
- See more at: http://cellceutix.com/cellceutix-advancing-treatment-for-hidradenitis-suppurativa-pre-ind-meeting-request-to-food-and-drug-administration/#sthash.A7rihQ9s.dpuf
And then confirmed this date in the following PR:
The data on p21 are expected to be received in mid-April.
- See more at: http://cellceutix.com/tenth-cohort-completed-in-cellceutix-clinical-trial-of-anti-cancer-drug-kevetrin-no-adverse-events-reported/#sthash.kNufdQUm.dpuf
So in flippernese that means sell, wait for a drop and then buy just before mid-April. I would guess we are going to trade sideways for a few more days then start moving up towards the preset catalyst don't need fancy TA to see this one. Its all new driven flipper controlled.
I must say I am looking forward to mid-April.
Hopefully government grants even if it does someday compete with Brilacidin.
I suspect that comprehensive update will coincide with uplisting. Generally, when Leo uses the word "comprehensive" they announce something significant... to say Hello NASDAQ!
And here I was very impressed with the low dose p21 results. The 10% threshold they put on it removes natural variations one might see so what is raising p21 levels then? We are now dosing 8x the dose from the first p21 test. And mind you they will also test this on tumor types that may not even have mutated p53. All signs have looked very good...but then I am a fool I still think spleen lesion in a stage 4 cancer patient is very encouraging. Remember this is mainly a safety study and has already become a success we are moving on to multiple phase2's. As far as stock price and potential drops what is the company currently valued for??? My answer at these prices is how smashing Leo looks with a yellow tie!
Last 10q stated the company planned on meeting with the FDA for B-ABSSSI in April.
And hopefully get some analyst coverage once uplisted because anyone in their right mind knows this one is greatly undervalued. If listed on the NASDAQ and started Brilacidin ABSSSI phase 3 we should have a mark. Cap. Of at least 1 billion for Brilacidin alone
With in a reasonable time frame I would not mind if Leo sat on some news till uplisting. Advancements are not likely to be fully appreciated on the OTC.
My take was it was recommendations for treatment for each mutant type for a particular patient not anyone currently any particular trial. In the one I read Kevetrin was suggested as a possible treatment.
I should note here that the blood cancers that MD Anderson and University of Bologna want to test Kevetrin against can spread quickly and to other parts of the body. Perhaps to give Kevetrin a "fair shake" at treating these blood cancers you need to know the highest possible dose. Too low of a dose and perhaps Kevetrin shows no effect against these cancers but with a slightly higher dose... all the difference in the world.
Something like this has been my theory for why U of B has not started yet and MD doesn't want to spend the money till that MTD is discovered...probably a good idea.
frrol, I noticed the same thing in the 10Q. Like the University of Bologna perhaps they are awaiting a higher dose/MAD/MTD??? Perhaps another similarity is that they are both interested in testing Kevetrin in blood cancers. What is dissimilar is that MD Anderson work would be preclinical while U of B would be a human trial.
When it comes to treating blood cancers it appears that the highest dose of Kevetrin is preferred?
We don't know what we don't know. The company could have received numerous offers to partner or more. Leo did mention this but he also wants to maximize shareholder value and what if he really, really mean this. In order to do that the only thing that is close to deal making is Brilacidin-ABSSSI but you cannot really do that till their FDA meeting is complete. You are not going to get fair value at this level for any of the possible indications for Kevetrin though this may change soon. Prurisol has to at least make it through one efficacy trial before any deal making can be done.
Kind of a funny thought, at least for me that the company could have politely turned down let say a 100 offers from everything B, K, P or perhaps anything in their entire pipeline from numerous large cap pharmas. Because striking on any offer at this particular point would not maximize shareholder value. It easy to see the under-valued stock price but it does not necessarily mean its an under-valued company.
Yep Gov. Leo has already mentioned it. Its hard to tell what will be appreciated on our current exchange. For some they will need to see the hard numbers which should be coming out soon- proof if you will. They got an incredible response of p21 at tiny doses and soon we will find out what happened after very exciting.
Really looking forward to that article presentation coming up and wonder if they can get that in to the late-breaking section at ASCO.
Be well
frrol, I absolutely disagree. They are not injecting Kevetrin directly in to cancer tumors its entering the blood and looking for them. Also to note here is that Kevetrin clears out fast too probably why the company is looking at dosing twice a week in future trials. There is ~100 billion cells in the human body. The 10% or better increase in p21 at low doses (think dilution) the highest of which may have only been 50mg/m2 for perspective we are now dosing at 450mg/m2 a 9x increase from the highest dose included in that 50% mark.
Part of the problem for me is that I don't know what normal levels of p21 are or perhaps more importantly how much it can vary in a individual without Kevetrin. But I am pretty certain that 10% increase threshold came from Dana Farber and know one would know better. That 10% mark removes any "natural" variability that might occur in p21. A little deceptive perhaps only in hindsight is that Kevetrin started dosing at very, very low levels perhaps more so for a chemo type drug but of course they followed protocol.
The smartest chap I know working in one of our research satellite labs here at the UW told me, after giving him all the details he has done p21 testing before, that we would probably see increases in p21 within the first 3 cohorts. And he was right, I posted this on this board some years ago. When asked how much of an increase one might expect to see he said maybe 2-3%.
To stick the bullet in the chamber and remove all doubt we need to see increasing p21 with increasing doses of Kevetrin.
"That p21 data is pretty important. Hopefully it shows higher response at higher K doses. The preliminary low-dose results were OK, not great. Anyone disagree?"
The interim safety report from any Brilacidin phase 3 trial might be a good spot to partner up. I agree, if they take all the risk on the phase 3 trial alone and complete it they might as well follow through with the NDA alone as well.
Nasdaq Capital Markets was not Leo's first choice if it was he could have made the move some time ago. The company aims high and wants to walk that way. Problem is after all that great news released in Dec.-Jan. period to see an already undervalued company price slide after fantastic Biotech conference then throw in the first short SA article that appeared to draw Leo in to releasing the Brilacidin-ABSSSI top-line stats?.....To state something to the affect of "we will be uplisting sometime this year" at the Biotech conference to only file the application a few weeks later something happened and I will go with frustration.
I think Leo and company got tired of the all BS of OTC/Pinks and said what the heck lets just do capital markets. So I am going with a whole lot of #2.
TD, I agree the hike is significant and Leo emphasis they cannot change protocol. Amazing stuff. Not too worried about the share price here and now both Brilacidin and Kevetrin are sailing over the fence.
My take on why "she" discontinued comes from Leo's statement in the PR...
"That’s an everyday practice in oncology, especially when a drug regimen, such as the strict protocol with the Kevetrin trial where dosing levels and intervals absolutely cannot be changed. - See more at: http://cellceutix.com/cellceutix-reports-spleen-lesion-disappears-in-patient-with-metastatic-stage-4-ovarian-cancer-in-clinical-trial-of-anti-cancer-drug-kevetrin/#sthash.L9R5xAAo.dpuf"
It sounds like she wanted to accelerate her Kevetrin dosing cycle to me. She was in the trials for 3 cycles, perhaps starting at the 150 dose that is more than 3 months. She probably got frustrated as many of us do with Dana Farbers pace etc. If Kevetrin can clinically stabilize a stage 4 ovarian cancer patient i.e. prolonged her life for 3 months that should be FDA orphan/fast track designation alone not even considering spleen lesion disappearing. She is still a stage 4 cancer patient perhaps Kevetrin stabilized her enough to go back to quicker traditional therapy.
When my father was at stage 4 liver cancer it would have been a miracle if he could have gone in for 3 treatments of a an experimental drug and then be able to go for a walk with me. I would have liked that very much. I think some people under estimate how sick stage 4 is..to me the patient is bedridden. Also remember this is primarily a dose escalation safety study it is not optimized for treatment. Due to the quick clearance, last I heard, the company would move to twice a week dose.
Harvard's Dana Farber allowed the Cellceutix to share this information..that in of itself is very significant.
Thanks Sox, for the Cox report.
Gov, the European conference is for Brilacidin ABSSSI.
Ultimate, the heptagonist was Delparantag which the company is now looking at as treatment for COPD Chronic Obstructive Pulmonary Disease its the 3rd leading killer in humans in the US.
At bottom of link: http://cellceutix.com/cellceutix-provides-update-to-shareholders/#sthash.1wbV6WmE.dpbs
Brilacidin sales=Daptomycin+Vancomycin market penetration will be 100% for Brilacidin for those doctors that know of it. Brilacidin surpasses efficacy of both especially Vancomycin and beats both in dosing duration. One day dose provided by Brilacidin will save millions for hospitals and insurance companies. They should not have a hard time accepting this. The only way Brilacidin does not capture all of Vancomycin market in ABSSSI too is if it is priced out of it which maybe difficult to do when you price in multiple hospital visits required for Vancomycin and of course Daptomycin too.
One cannot even get a 1 day antibiotic for an ear ache! The only thing we got to watch out for here for is Polymedix syndrome caused by acute exposure to Brilacidin and the development of extreme arrogance it eventually leads one to try signing the checks to creditors with the signature "amazing drug". =-) IMO
Here is a summary evaluation report from Roth Capital for Polymedix back in 2010. Apologies if this has already been posted.
http://www.investorsinsight.com/blogs/steve_cook_on_disciplined_investing/pages/more-bs-from-obama-monday-morning-chartology-update-on-polymedix-10-bagger.aspx
Well the company is ready to uplist the science behind its drugs, their progression and results to date are all ready to uplist. But too many of its investors are not.
I think Leo should bite the bullet and shot for the NASDAQ Global Markets and see if we can shake off some of this trash.
WANTED: Quality Investors... Do you have the ability to hold a stock for more than 30 days? Do your actions follow your words? Any kind of integrity? If so, I would like to invite you to the investment opportunity of a lifetime here at the Cellceutix corporation!
Other desired qualifications: a full-time job outside of the stock market realm and little to no desire to study stock charts on a daily or weekly basis.
TD, can we get one addition to your statement
"Folks that think this is dead money for 8 months or whatever are going to be surpised. I say let them go. I just wish when they do sell they would go quietly and not make announcements about it."
OR BUY BACK IN AT A LATER DATE
Also is surpised a typo for surprised or sure pissed?
=-)
Can we get a stickie for the Biotech Showcase power point slides?
http://cellceutix.com/wp-content/uploads/2014/06/Cellceutix-Slide-Deck-BioTech-Showcase-12-Jan-2015-B.pdf
My understanding too was the $4 bid not the close to reduce manipulation. Far as I know the clock is still ticking on the 90 days but I don't believe this will be the pathway to uplisting. I am guessing its going to be the upfront cash from partnering Brilacidin ABSSSI that will provide the equity needed to uplist the deal will also bring stability after uplisting.
3 doses I believe, she completed one cycle in one of the cohorts. Given the timing she was in cohort 7 or 8
Its kind of amazing how much information they have on the patients in the Kevetrin trial. The 59 year old women for example going for walks with her family, feeling better, by dose 2 stable spleen lesion but concern for a rising CA. This level of information I assume is known for all ~39 patients that are or have been in the trial. Makes an investor realize how little we know.
I will say this though if management says that Kevetrin is performing as expected..WOW! One need only go back to the preclinical work. They didn't overplay Brilacidin ABSSSI top line data which IMO came in over expectations so now consider that scenario for Kevetrin.
ETL I will give you that one for the extra commentary.