Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Dr. Jerry, Oregon (OR) is a beautiful state its easy to get distracted there.
The flipping swingers are going to start cracking me up here. You bought on the low during the dilution and sold today or over the next day or two (congratulations on the profits!) but when are you going to reload? Big catalysts coming soon, how are you going to pull this thing down for a proper reentry point? This is not going to test support again! I might buy more tomorrow just to mess with you all.
Happy Trading
This late selling pressure maybe a good thing to sweep away the flipping swingers that bought at the bottom.
Thanks Gov, I would think this type of information "i am looking forward to JP Morgan update for clarification on 8 participants in cohorts 4 & 5 instead of six. also cohort 6 took a longer time than usual." would be presented at JP.
Canes, your reading of that amendment resembles my own understanding of it.
Whoops scratch that last post BK, "efficacious levels" got it. Hard to think when you have 4 and 6 year old boys jumping on your back while reading.
Thanks BK, do you think there was evidence way back early on ~cohort 2-3 range when Leo made the statement that ultimately Kevetrin maybe dosed twice a week? Your explanation sounds rather reasonable because it excludes the "red spot" issue which should be a non-issue. If so, why didn't they amend the protocol way back then?
Glad you mentioned chemotherapy cycle I am trying to quantify in my mind ultimately how K will be administered. This was brought about from the following statement "filed an amendment to the trial protocol with the FDA to limit the dosing duration of Kevetrin to six hours." from the last PR and coupled with the fact that much earlier on in the trial Leo stated K at some point would likely administered twice weekly.
My thought here has changed some perhaps if the intent of amendment is to decrease the infusion rate by expanding to 6 hours instead of 1 hour its walking more towards the twice a week regime Leo mentioned early on. I believe when we first heard of this twice weekly dose theory it was around cohort 2 infamous reddening at injection site which seems like it would be a typical event for a injection but why would this lead to the safety board having to consider it a grade2ae event or any consideration. I am drifting here but we may be closer to a DLT than I previously thought if the amendment is to reduce the infusion rate over a longer period of time. The company did say they expected a DLT somewhere between cohort 6 and 9.
Just ranting
"Very true many drugs at one or two doses will not be toxic but when give weekly for months on end may become so. This is another good test of the safety of Kevetrin for dosing over long treatment cycles like 6-12 months that are typical of many chemotherapy protocols. Good thought."
RR conference presentation link to get us warmed up for JP. http://cellceutix.com/wp-content/uploads/2012/07/Cellceutix-Rodman-Renshaw-20131-1.pdf
May I recommend slide 9
Canes very excited about cumulative effects. On the company website there is a graph on some preclinical that shows just that even at lower doses, if I recall correctly. The effect has already shown up, from the RR conference:
Observed stabilization of disease by restaging in multiple types of cancer
• Evidence of stable disease by radiological examination in 6 cases, which includes head
and neck cancer, ovarian cancer, liposarcoma and clear cell carcinoma
• Disease progression occurred following stabilization of disease in some cases
• Subject 103 had 6 months of treatment and 2 successful restaging with stable disease
• Subject 202 completed 4 cycles of treatment
*Stabilization was achieved at low doses in terminal patients with relapsed tumors that were
resistant to current chemotherapies
JP conference should be very exciting these subjects are all low dose. Cohort 6 was at more than double the dose of the highest dose given here (50 cohort 3, cohort 6 110). Moreover, all these subjects are stage 4 terminally ill cancer patients that have no success with other treatments. Of all of the cancers Head and Neck and pancreatic cancers are two of the worst. You can see head and neck were one of the subjects. It would be nice to see a pancreatic subject in cohorts 4-6.
Not as exciting as stabilization or shrinkage but important information is the number of treatment cycles not only for cumulative effects but also how tolerable K is over a treatment cycle. Interesting play between cumulative effect and whatever MTD we get.
Buc I agree, I believe Leo gives us all he can and he would tell us more if he could. The NDA with DF and BIDMC should be held with upmost respect but what a weird setting..mums on the PRs but OK on the investors conference. I am guessing its a little more dynamic than that but that is how it appears.
Been invested here a long time Leo and Dr. M are very enthusiastic during slow periods in the past I used to joke to myself that Leo PR investors if he had a good meal somewhere (JOKE!!). If they could, they would, no doubts for me there.
Good point Gov. The timing of this conference couldn't be better. My thought was Leo has something to tell us and wants to do so before ASCO deadlines muzzle him. But also it puts a big catalyst at the start of the year to insure that there is no monkey business like last year at this time.
I did some selling in my stock accounts recently for tax purposes (of course not CTIX) just like last year if someone tries to go monkey on us..I WILL STOP THEM =-) I gave them a hell of a fight last year and the cherry on top is that I have more funds this year.
I just hope Leo buts the JP conference Kevetrin update in a PR afterwords. I think he might this time because he is framing it up as a year end update. The great information given about K at the RR conference was never PR'd, would be investors would have to go look for it in the slide show hence no articles written, SA or otherwise.
Getting really stoked for the JP conference. Take K trial cohorts 1-3 and multiply for the dose increases of cohorts 4-6 and disclose this information RR conference style at the biggest/most noteworthy investors conference you ever presented at and >>>Kaaboom! Plus p21 conformation! Probably the biggest catalyst the company will have to date.
Leo is also setting a trend here with these investors conferences in that is he is showing he is now going to attend/present more frequently. In years past he only did RR investor conferences. Probably a natural development because he now has something to report.
BK I think you will hit this one perfectly. A lot flippers started posting near the bottom which means they were looking to buy with the dilution off but it was too early for jp catalyst. Looks like a mini dip for early next week but reloading before potential Friday catalyst. This should be the last dip before JP. Should be over 2 preconference.
Agree 100% they will eventually miss the boar though.
My fun range is 0.19 to 1.99 over a 3.5 year period. Will buy more if warranted.
Right! Thanks Gov....GO DR.HERBERT!
Great post Orion! And don't go back down the rabbit hole! I don't recall anyone bringing up the heat shock proteins before and HSP90 pathway to tumor growth. You should try sending an email to Leo he might be able to answers some questions here. But
2 Things
First, if we were in college together would you do my homework for me?
Second, I think TruthbyThought and Ardhee are the same person.
Keep posting please!
GO MOLECULAR TESTING LAB AT HARVARD! Is that the correct name Gov? At this point I think we should be cheering for them so Leo can give us a fair update at the conference.
I think K is going to get us uplisted soon and perhaps our first partner.
Cabel I like those numbers if its only for K if B starts up on time I would add a 0.25 post conference. Too many variables and background noise but great news from cohort 4-6 we can go much higher.
Its crazy to guessitimate pps but fun to do
The dilution is off and big catalysts for January. Its X-mas already in CTIX land.
The news flow for Kevetrin is actually looking pretty good now if we get a comprehensive update including cohorts 4-6 at JPMorgan. ASCO submissions are early February which I believe calls for somewhat of a news blackout period although Leo should be able to let us know cohort progression during that time and if there is any DLTs. If we can get up to date in mid-January there may not be any significant news on K to report, other than those mentioned till ASCO. I believe ASCO abstracts can be updated after the submission deadline in February?? If so, ASCO could present us with news on cohorts 7,8, and hopefully 9.
Yepee
Great post Orion. Thanks
Thanks Wild, great info there!
I would think healthy patients
They are just looking at mechanics.
Thanks BK, here is the wording between the two PR's
From October
"The study documents the ester bond in Prurisol™ (a prodrug) is readily cleaved and converted as expected. This study was requested by the Food and Drug Administration to be included in the Investigational New Drug (“IND”) application with the FDA under a 505(b)(2) designation."
http://cellceutix.com/cellceutix-completes-final-study-to-file-ind-application-for-new-psoriasis-drug-prurisol/
Today
"Because Prurisol is an ester of abacavir, the FDA has requested that Cellceutix conduct a short Phase 1 crossover study to demonstrate that Prurisol converts into abacavir in humans before initiating a larger-scale Phase 2/3 trial."
"IF" they performed the PoC in Europe they would have known this =-)
Good to hear the FDA is more concerned with patients in clinical trials than the EU is..
What all seem to be missing is that for Prurisol to begin trials in January, even a small Phase 1, CTIX must file the INDA before end of December, or sooner. Get ready for the PR announcing the filing of the INDA. Many on this board have been touting that as an expected benchmark and a make or break milestone for end of year share price; well, it's coming, and right soon.
They aren't asking for proof showing Prurisol converts to Abacavir; they are asking to show that as a salt of Abacavir it converts in a similar way. That is why it is a short duration, small study. This is the bridge part of the study, that the much expanded PoC cancelled end of summer, bridging Acabavir processing and elimination to Prurisol's.
Contract research organization the folks that will be running the B trial.
Looking forward to January. Is the conference broadcasted on the web?
Great PR..my take on it...
They finally address the P scenario. Further proof required to show Prurisol converts into abacavir. This may be why it took Dr. Reddy's so long on the manufacturing side, hopefully it worked out. I don't expect P trial to be up and running till mid-year. But...
B is starting soon. I believe they are using the same CRO as B2a so getting everything through the IRB should be good. They might be able to hit their timeline here. Here is the link to the 2a study in case anyone is interested http://clinicaltrials.gov/ct2/show/NCT01211470?term=PMX-30063&rank=1
The elephant in the room, cohort 7 K with increased dose! The amendment may help reduce delays with some patients -making sure cycles get complete. Also, it may speak to the fact that they are not seeing a DLT soon from PK data.
Two confidentiality agreements “Since last month’s Elsevier conference" sounds like someone is interested in B or at least perhaps something in the old Polymedix pipeline. The wording hear makes me think Leo is giving us a hint at that. Phase 3 for antibiotics are usually rather large due to widespread use of antibiotics. Glad to hear there is a chance that someone will be covering p3 for us after 2b.
JP Morgan conference maybe the big news. Science likes to do things in 3's with cohort 6 wrapped up we could get a RR conference style update for K cohorts 3-6 soon! Plus update on carryover patients! Gov. dare we dream here?
Couldn't be happier with the update. Some may point to the P situation but I am just glad they let us know what the delay was about.
Just Ranting!
Gov. I am glad they finally spoke to us of Prurisol. Over the last year I got the feeling there was something wrong and finally they speak of it. What I don't understand now is what happened to the bridge study they had done by an outside CRO...that was just last month they announced the completion of that and there was no cleavage concerns???
Thanks, this may speed things up by allowing patients to complete their cycle. I assume they made the change due to some patients not complete in 1 hour.
Thanks Pete, where did you hear current dosing is only 1 hr? The wording is not clear in the PR to me limit to, versus expand to. If they are expanding I agree that is a good idea.
I wonder if some of the delays in completing some patients in the cohorts is due to them not being to complete the dosing in just 1 hour. They may be challenging for some stage 4 cancer patients. If this is so it may speed things up in terms of patients completing their cycles.
Great PR. Looks like they are trying to speed up the K trial some by limiting the dose time? Anybody else read it that way? Or at least remove a scenario that may cause delays.
FDA to CTIX run the darn P PoC =-). Glad to finally hear what is up with P on the upside B is starting sooner than originally thought.
Gov I think a lot of investors should be grumpy. When I stated after the RR conference "why would you do this to your longs" I meant it. And while some here where critical of me while they were selling off holdings, it was true IMO. If I was a smart man I should have sold too. I think we have perhaps only temporarily lost some of our longs and replaced them with a lot of swing traders =-(. We should be through our rough patch if we get a cohort update and a P IND. The P scenario has been weighing on this stock all year.
The company needs to appoint a BOD not just for the purpose of uplisting but rather for guidance.
Gov you know I am big admirer of yours not just because your in here rolling the dice with a OTC but also your the only poster I am sure is saying exactly what you think... Kudos to you!
Even IF it shows half the potential it did in preclinical work. I find funny when ppl mock others price EST. Of $100-150/share it could be so much higher
Gov. where are you? I get the feeling you have been a little grumpy with CTIX lately? Is today any better? If your going to try to go two days without posting I am going to start missing my Feisty/Spirited Ladies posts!
Grizz, Leo used do to all the PR's after Friday close...he gets weekly updates on K on Fridays.
Tails thanks for staying in the here and now...KKKKKK cohort 6 should be wrapping up at a therapeutic dose at 110 which is particularly exciting because K seems to have some effect at lower doses already! In my view the value of K goes up exponentially with each cohort now..will it be a stand-alone drug for many cancers or used more frequently in combo treatment???? Also waiting on confirmation of p21 increase. Very exciting that we have carry-over patients from earlier cohorts because K seems to have a strong cumulative effect as well.
Come on Leo..tells us something about K!