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BK, thanks for the big chuckle on your last sentence there. I needed that..how dare u make me wait that long =)
Thanks Etrade, its taken me about 8 months to fully appreciate the acquisition of Polymedix and overcome the "distrust" of their pipeline due to their bankruptcy. Polymedix ship went down in the perfect storm. First they pledge all of their assets to MidCap financial and promised to make lofty payments, biggest mistake. The anticoagulant drug Delparantag which had the potential to be a block-buster drug failed then people started looking Brilacidin 2a data with some SAE's and everyone bailed. All these events happened in short order too!
First off Delparantag is not in the defensin-mimetics platform the majority of the 16 compounds in the pipeline we have now are. The only problem with Brilacidin 2a data, IMO, is that polymedix didn't realize soon enough that B had such a long residual time in the body which is great if your not overdosing it. Brilacidin is powerful and it stays so in the body opposite of Kevetrin which appears to clear relatively quickly.
That last PR from CTIX was huge for me. Brilacidin is halfway through the trial with no SAE's which should be the only question/concern we should have for this p2b IMO, IMO.
Ironically, when this deal was announced several former polymedix shareholders started posting here on this board. The drug many of them liked from the poly portfolio was an antifungal drug that CTIX hasn't really mentioned yet, perhaps the best is to come!
Invesor, I think you definitely wait till after 2b for several reasons. First the 2b study is nearly complete. If you have stellar final data let the competition begin officially when the data is published you may attract potential partners you weren't talking to before. Next with completion of the study of Brilacidin will be de-risked even further demanding a higher price. Finally, it will give us time to see if congress passes the ADAPT act. If this passes it should raise the value of Brilacidin to any partner by reducing the cost of the partner to bring it to market. The ADAPT act on top of the GAIN act could lead to quick approval.
The company has put a little pressure on itself IMO on partnering B after the 2b study. A phase 3 for an antibiotic could be expensive because I believe they are typically large trials because antibiotics are used so broadly. Of course we are a small biotech and cash-strapped if there is only one interested party in partnering this could be leverage against us. Put the data out there for the world to see!
The thing I have been thinking of lately is do they partner out B just for ABSSSI or try to get someone to bid on the whole platform B-OM, ocular etc. Good news from the phase 2b ABSSSI also boosts Brilacidin in its other indications, secondary confirmation if you will. I suppose it all depends on if the "price is right" but also leads one to think (again) ultimately what the company wants to do; be bought out, make a run at being a major biotech, or somewhere in between. Frankly I would love to see them get a big chunk of cash from B and use it to create a spiders web of clinical trials for Kevetrin against every dam cancer there is =-)
Very exciting times from all indications B 2b is doing rather well with no SAE's and running along smoothly ahead of schedule! Although this is a double blind study, B is only 1 or 3 day treatment with Dapto at 7 days. The interesting thing is that B is not placebo'd out to 7 days. If you "look" close enough the study is not blinded at all. One thing that was lost some from the 2a study polymedix performed is that B appears to be a very powerful antibiotic with a long residual time which may have gotten in to some trouble at repeated high doses. CTIX has laid out a great plan of short course treatment that will reduce or eliminate SAE's and at the same time give it a massive market advantage.
Go CTIX
If I recall the story behind Prurisol correctly it was first brought to Dr. Menon from a University in India, of course strong ties there. Dr. Menon was not pleased with its performance so they tweeked it in to its present day form.
I am surely not a biochemist but when, where and under what conditions a molecule cleaves can make all the difference in the outcome. I think its too simplistic to ask how is prurisol different than the antiviral drug likely requiring the knowledge of a PHD biochemist to understand the difference. I think we all feel we know how Kevetrin works but if you get in to the details of how it really works few will understand.
If you look at the prurisol patent application there is one significant finding in the patent search from Europe from ~23 years ago from the original antiviral. This is likely to be first time that psoriasis is mentioned in the same context.
Have you read the prurisol patent yet?
Etrade, I completely agree with this. The active/ongoing dilution does the pps no good no matter how sweat the Aspire deal is. We are half way through B 2b with no SAE's the 10% non-inferior should not be a problem. A partnership here could set us free!
Mr. NR two months has been the average through out this trial except for maybe cohort 1. Another way to look at it is would Harvard be wasting 2 years on a dud? The delay for the most part IMO is from the terminally ill stage 4 cancer patients not blaming here stage 4 cancer is brutal.
Ten years ago my father had lung and liver cancer diagnosed at stage 4 there would have been no way I could have motivated him in his condition to go to weekly for 6 hours infusions. I might have been able to get him to go one week but he surely would have not gone the next. He was actually in Terceva study but never finished it.
The prurisol trial is right on schedule, set to be completed next month. Its common on this board for posters to jump ahead based on what Leo PRs. If the Leo states on March 17th that cohort 7 is underway people assume the needle is pricking the patients arm that same day. Rather it just might mean that they are starting to recruit and no one is getting poked for a week or two.
I know what you mean its frustrating to wait..Gov talked me out of a emotional break down just the other day and I officially fired Harvard 2 months ago =-)
Delaying the p21 news is an excellent idea. If they would have announced positives results 6 months with nothing else to back it up, all gains in market cap. would have been lost quickly. I believe its completely strategic at this point. Announce it when you can back it up with other results.
My reasoning is..sure the test are expensive but your going to do them anyways and I doubt there is a bulk discount for running all the tests at once. Looking at the p21 data from the first three cohorts at low, low doses and its already there of course you have it at 165 but please Leo let them blood samples sit in the freezer!
A Harvard farce?
Thought someone posted a block of 450k on bid with a excellent broker to boot.
Thank you Gov! I feel better now....can I have ice-cream for dinner tonight??? =-)
Gov, your bumming me out =-) On the other-side of possibilities is that safety is becoming a real concern perhaps multiple Grade2ae events and we are approaching DLT and the MTD cohort?
From April 14th PR
"Phase 1 trial of Kevetrin for solid tumors is progressing with no SAE events presently in the seventh cohort of the trial" with the start of cohort 7 ~March 19. So we are approaching the 2 month average for a cohort maybe its business as usual? With K clearance time one might think if the patients could handle 165 the first time they should be able to handle it the second and third time?
Just hoping we can make it in to cohort 8 now. Wait, scratch that I believe they are getting the paperwork together for FDA Breakthough! Geez, I am becoming an emotional wreck! =-) Is it good, bad or fantastic?
What was Prurisol dose level were we hoping for in the advanced P trials was 200 or 300?
Just Rant'n
a slow cohort 7 might also mean that what before was a minimal (grade 1) side effect becomes a more severe (grade 2 oe 3) side effect. this in turn would cause longer recovery time for such nuisances as vomitting etc from one week to two. i think they went for the shorter infusion time in order to preserve the twice per week dose option. i am only musing here. this could also mean more excessive caution from the IRB board.
by now the P trial cohort 2 group has been dosed and samples taken - also leo knows if that stuff turns into abacavir. only maximum dose needs to be tested but we have to wait for washout period. if not converting i believe they would stop trial and not waste money.
IF P converts on to proving cure.
A slow cohort 7 might be a good thing. Instead of just simply looking at the next dose increase perhaps they are looking at something else???
So we are going to get a halftime report on B vs D in the coming weeks (soon/forthcoming)? I like the vegas line on this will spot B 10 points and D 4 to 6 days.
I too suffer from DFSS and I am not ashamed to admit it! When K p1 results finally come out that DF check mark on the paper better be worth it..
ETL, I was not referring to you as a flipping swinger. I don't even recall reading any of your posts this morning. You seem to be sufficiently mad enough to be a long =-)
PS Thank you for taking care of my box of puppies this weekend! They are my pride and joy and I am sure they will be safe IN your hands. =-)
How close is Brilacidin to market if the ADAPT act is passed? I like to thank all the posters that brought this up. The bill is H.R. 3742 sponsored by Phil Gingrey. The bill has support from both sides and seems to be a lock for passage if they get around to a vote. Looking at the links below if the ADAPT act is passed could we go for limited FDA approval at the end of phase 2b?
http://beta.congress.gov/bill/113th-congress/house-bill/3742
http://www.fiercebiotech.com/story/bill-would-fast-track-promising-antibiotics-fda-approval/2013-12-13
Just the flipping swingers seeing if they can get this to drop anymore before they reload. The pattern continues.
Grizz I have been banking/betting on that since cohort 1!
Flippers won't pass up on the nearly 20% gain.
Integrity-Tom if you want to run with the big dog flippers here your going to have to get ahead of those bar-charts your looking at americanbulls.com
The flipping-swinger sell sign was ~5 trading days ago on diminishing volume and a fading green light. Need to get up off the porch here or they big dogs will eat'ya up.
I will order off the value menu =)
Will see. A lot of flipping swingers on this board. Their comments are negative or positive depending on where we are at in the trading channel or if they are holding or not holding.shares.
He has been saying that for as long time.
I wouldn't mind a serving of UofB or BIDMC renal too. Last I heard UofB was slated to start in the first half of 2014
Can we stop on Mars temporarily? I would love to dig a hole there.
If there is something to it you got to think K and not B or at least I do. But then if the price is right...but then there is truly numerous options outside both of them too.
Exciting times!
Leo is oddly silent.
Platforms..I am liking this description for Kevetrin and Brilacidin. The platform description of "defensin mimetic" is now being validated with CTIX 1278. With all this antibiotic resistance CTIX is sitting on numerous preclinical compounds developed under defensin mimetic platform and could perhaps produce more. Wonder how many more of these compounds the government funded colleges and universities would like to take a look at? Our draft selection of Dr. J from old polymed is going to payoff big time!
People invest in drug platforms for obvious reasons. Two of my greatest biotech picks Seattle Genetics and Micromet had platform technologies. I had SGEN go from $8 to $38 and Amigen bought out Micromet early. But my greatest investment will be the little company that had two very good and very big platforms.
Don't let the current pps fool'ya we have a company that has a cancer platform and a antibiotic platform with a bipolar market cap. of ~200 million something going to give here soon. I am flat-out afraid not to be holding every share I can.
Just Rant'n
Thanks Echo for posting that it would nice to see a run on drug companies that are actually working on producing new antibiotics especially novel ones such as Brilacidin that can offer short-course treatment to compensate for human inability to stay on a prolonged treatment....
"concentration-dependent killing, long half-life and post-antibiotic effect allow for shorter therapeutic regimens than conventional antibiotics". - See more at: http://cellceutix.com/brilacidin/#sthash.nMHN9I3V.dpuf
Heck we get pigs dying and pork prices soar but if we run out of effective antibiotics the creators of new effective ones don't get much love. Whats more important pigs or people? The markets will wake up any day now.
Your a gem Gov..thank you
Hello Gov! Is there just one article SA from last Friday? I am working out in the field today with limited WiFi. I have not been able to read any articles. Thanks
I hear that one3 times a day but I do have young children.
BK any young kids? Perhaps Cellceutix is in a "Whole New World" dam I love that song too
Perhaps cohort 8 is a go? It can't just be that the market has come to its senses?
Too much volume for just a SA article? And it seemed like our flippers were already fully loaded or should have been
Perhaps there is something here that wasn't before...Dang I got to stop watching Disney movies I think that is from Beauty and the Beast
On Prurisol from the last PR "patient screening is ongoing in the Phase 1 trial of Prurisol for psoriasis" is this the screening for the hypersensitivity to abacavir sulfate? Or other exclusion criteria "interviewing"? Or is screening ongoing in reference to the 18 patients under treatment? I assuming its not the latter and that recruiting is over.
I am sure the company considers that having to do the crossover study is a setback, darn FDA, so I wasn't sure how detailed the news stream would be from the trial. We might just get a PR a couple of months from now stating the trial is over. It doesn't sound like something Leo would do, but...I am trying to gauge where its at right now.
I think the word that is throwing me off is "patient" or perhaps its "patience".
What we need is a RR style conference that is not featuring Brilacidin. So Leo can update us on K without Harvard knowing it.
TD your a gem!
TD, you need to put a "all" in post your between about and tumor and we are golden.
BK, this makes perfect sense and they are not going to have sample size in any one tumor type because the trial is spread amongst so many types, as it should be.
Hello Gov, no AE's in B 2b with 30% enrolled! Lets partner this one and use the cash to advance K in different indicatios like retinoblastoma! Charge!