A 1 to 3 dose regime with B will be patient, doctor and insurance preferred if approved B should immediately start eating in to Dapto market share. Its foolish to compare 98 to 95% response rate between B and Dapto once approved it will be irrelevant. If you have a infected wound on your leg do you really want to be dragged in to the doctors office 7 days in a row and be hooked up to a IV bag versus 1 or 3 days?

The short course treatment will also help B with resistance because of limited exposure to the drug and the fact that more patients are more likely to finish a 1 to 3 day treatment opposed to 7 day. Oh and don't forget B has innate quality called defensin-mimetics the drug is not ingested by the bacteria rather the drug rips off the plasma membrane from the outside also reducing (greatly) bacterial resistance which is great because under the GAIN act they will get extended patent coverage, which I believe is 15 years total.

After this 2b study if Cubicin is not the partner announced for the phase 3 study their management is smoking something a little better than what I can get here in Seattle.

The DF lockbox is driving me crazy well crazier

Finally something we can keep track of! =]

Curious to see what type of pace Leo will put on the enrollment PRs. I'm down for weekly updates so I can read more posts about people complaining about the fluff :-]

Leo is going to love the B p2B because virtually at anytime he can PR updated enrollment numbers and he does enjoy keeping shareholders updated. Unlike some that think that every PR should make them rich i just appreciate knowing how things are going.

Surprisingly, not in every arm of the study goes 7 days from the gov site

Experimental: Low Single Dose Brilacidin
0.6mg/kg Brilacidin IV (single dose) on Day 1, followed by placebo Daily Days 2-7

Experimental: High Single Dose Brilacidin
0.8mg/kg Brilacidin IV (single dose)
Drug: Brilacidin

Experimental: 3-Day Regimen Brilacidin
0.6mg/kg Brilacidin IV on Day 1, followed by 0.3mg/kg Brilacidin IV on Days 2 & 3
Drug: Brilacidin

Active Comparator: Standard dosing regimen Daptomycin
4mg/kg Daptomycin IV daily for 7 Days
Drug: Daptomycin
Active Comparator
Other Name: Cubicin

The low single dose matches nicely, one day B the rest filled with placebo to day 7 to match Dapto. But on the single high dose they only list one day with no placebo fill-in and on the 3 day regime they do not list 4 days of placebo.

On the double blind neither the patient nor the clinician know what drug is being administered, all they will have is a number on the IV bag or vial from which it was made. For example, patient #7 was given vial #11. Only when the study is unblinded at the end of the study can they see that vial #11 for example is Dapto. In the end they go back and match up all the numbers.

The clinician and patient will be able to see that the wound is healing but will have no idea what antibiotic was used.

ASCO?? Did someone hear that the company would be presenting at ASCO? If so, what would they be presenting? The abstract deadline has passed and the company has not PR'd anything about presenting.

They did Kevetrin p1 solid tumors last year as a "work in progress" I wouldn't they would be able to present again this year in the same category unless they move up to a "work still in progress".

The only subjects left would be Kevetrin preclinical work or perhaps B-OM?

14 patients in 9 days in B 2pb that is a pretty good clip and they expect the rate to escalate. With out any additional acceleration that is 1.55 patients/day and about 133 days to 200 patients.

Nice find Mike, my take on it is that certain gene mutations respond poorly to current therapy. For example triple negative breast cancer with a gene mutation in TP53 (p53) will respond poorly to current treatment but here is a list of drugs that can potentially be "gene therapy" for these bad cancers...and Kevetrin made the list for p53. Pretty cool the author knew of K!

Where do you get that efficacy was all over the place from that presentation? I don't really think u can state that unless you have the individual data? The data looks like the p2b study is perfectly designed. There is always risk

Bring on cohort 8 and DLT! Lets see what we got.

Nice all 4 B p2b sites are now open.

BARDA is seeking additional proposals, it would be nice to get some funds for the preclinical pipeline.

We could also see a update on UofB K p1b/2 or BIDMC SPORE grant for renal.

HERE, HERE! Well in my particular case not by the standards of Washington State Law. The FEDS might swoop in and get me soon, but I am a free man as we speak!

Bought before George Evans

LOL, and here we are together! And all we have to do is wait...which apperently for some is very difficult to do.

I have been in biotechs where just reaching enrollment or just reaching it early have been major catalysts, of course when favorable outcomes are expected. Never know with CTIX though

The Brilacidin p2b should be enrolling about ~1 patient/day if the estimated primary completion is October. Leo should be able to give us updated enrollment numbers from time to time. I wouldn't expect anymore than that in this double-blind study.

The short course treatment if proven out should be huge, doctor preferred and cut in to Dapto market rather quickly..exciting opportunities! Oh and thanks to the GAIN act, 15 years on patent and a minimized chance of bacterial resistance.

Couldn't argue with that when they finally release the final data there will be cocktails at my place. It "feels" like we are coming to the end but hopefully they can squeeze out one more cohort.

I have been reading the gov.trial site for B p2b its kind of amazing how much they have "handicapped" B versus Dapto. One and 3 days regimes plus placebos versus Dapto 7 day regime.

Has anyone else been concerned with re-infection at no fault of B other than the short-course treatment and the human inability to keep a band aid on?

Well the dose increase is dependent on the no# of grade 2 AE events so their is rules written out. It will be what it will be =-)

Whoops scratch that its only 215 patients not 300.

Leo should be able to keep us up to date on B p2b by periodically giving us enrollment milestones 10,50,100 patients etc it will be a nice change of pace from the slow moving cohorts in K. We hit 300 wait ~30 days and the data is complete. Fun stuff.

Thanks BK, woot B is going live!

Someone help me out with the word "recruitment" does this mean looking for patients to treat or ready to treat patients?

With ABSSSI I assume recruiting would have to be a bit on the fly such as people just coming out of the ER.

Great PR, the plot thickens in our CTIX novel.

Thanks Gov, do you know if they actually examine the MRIs or just file them away for later evaluation?

Its a bit much to hope for but K cohort 7 could be going to the safety board this coming week? Grade2AEs or no grade2AEs going forward it would be nice to see only ~33% dose increases. Either way 33 or 50% increase will put us over 200, ~220 vs 250.

I know Leo said they expected a efficacious dose to be between 100-200 mg/m2 and they expected a DLT between cohorts 6-9 but does anyone from prior company comments or perhaps back to the preclinical work have a number or range for DLT?

WHAT! The swingers are turning their hats around? I am shocked!

We don't need a SA article to counter a SA article that indirectly affected our stock price. Pump and dump, pump and dump where does it all end?

What CTIX needs to do to move the share price is present facts on progress and results. A nice hard-core fact that should be announced at any time is the start of B p2b we should move up then. Cohort progression in the K trial should move us up but often doesn't but it is a factual item as was the polymedix deal.

The company has released few facts on K trial. The tumor stability at RR conference and a whisper of shrinkage at the last conference are not proven facts..we need numbers and a official declaration of these items before they get priced in and also IMO institutional buying.

All we need is patience and the facts, facts, facts will come!

ps glad to see so many swing traders have left the CTIX stock! Hang in there NR!

BK, any thoughts on why the reformulation of K is needed for the UofB trial? Perhaps feedback from UofB during their preclinical work?

Leo on the road, wonder if this is the site initiation for ABSSSI? One of the sites for B p2a was Ukraine. In India Dr. Reddy to formulate B-OM? Do we know the original manufacturer for B?

Patience Bunny, its all you need.

The only problem we have here is that NNVC was "ripe" for a bear attack after the RS and overvalued given its level of development (IMO). Some people are taking SA rip on NNVC as gospel but actually know that it is a baseless hit piece. Flipping swingers cannot make money without volatility. I don't know why SA publishes this crap.

So this indirectly affects CTIX. All I have to say to those selling today because of that hit piece is... Goodbye! We are better off with out you and as a personal favor to me please don't buy back in when you "think" we have hit bottom =-).

B phase 2b starting anytime now and I think we will get and hold over 2 once it commences.

The submission date for ASCO abstracts has passed, February 4th. Perhaps for the better avoiding ASCO news black outs.

Yep, bring on K p1 cohort 8 solid tumors, K p1b/2 renal, K p1b/2 leukemia, B p2b ABSSSI, P p1 psoriasis. At some point soon the news stream from all of this will make this rather exciting!

ASCO..yes or no should find soon.