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I do hope that the company is willing to enter in to a partnership with Brilacidin ABSSSI sometime after the FDA meeting and before the start of any phase 3. They have a enviable problem in that their pipeline is too deep. A lot of money could be spent developing it all and I am sure financing it will not be a problem for them but it all comes at the price of dilution. Since they are not interested in marketing the drug after approval they might as well share some risk with a partner for a phase 3 and beyond. The initial cash from a partner could fund the company for a few years. Heck, Brilacidin is a powerful, novel antibiotic with 15 years of market rights they could be looking at 100 million or more upfront. I agree with Mr. NR too running a second arm for the 3 day dose seems attractive to me but one would have to see the costs involved. The 3 day would not only act as backup but also you hate to see 98.1% success rate go off the table.
On Kevetrin, I hope they don't turn the phase 1 in to phase 2 efficacy at Harvard. I work at a big university and efficient they are NOT(I cannot emphasis that enough)! I am for finishing up phase 1 at Harvard then go out to a CRO/public hospitals for the phase 2's. Kevetrin appears to be working so get it out of Harvard so it can start saving more lives. If it was me, and I am glad its not, I would walk away Dana Farber p1 results in hand even if they offered to sponsor some or all of the future work. IMO, IMO, IMO
SLC you and your brother rock! Thanks a million!
3 doses of Kevetrin to make a cancerous spleen lesion to disappear.
A CA 125 test measures the amount of the protein CA 125 (cancer antigen 125) in your blood. A CA 125 test may be used to monitor certain cancers during and after treatment. In some cases, a CA 125 test may be used to look for early signs of ovarian cancer in women with a very high risk of the disease.
Thought I was going to have to wrestle an Ipad from an elderly lady walking down the street but I made it back to my laptop!
Running!=P
Karin, did you get a meeting with him?
Don't remember a PR just before a conference inviting investors to attend before. Woot on 10th cohort at 450 mg/m2!
You were asleep
Thanks NR..great post
On to $5 biotech in 4 days.
Yep, CTIX performing very well given the crashing markets. It will nice for consumers to spend their money somewhere besides the gas pump. I am particularly enjoying Putin's Russia feeling the screws perhaps they will not be able to afford invading anymore nearby countries!
Congratulations All! Fantastic results on the primary end point. Looks like Brilacidin 0.8 mg/kg single-dose will be our phase 3 dose. Hopefully we get that "additional information" to the FDA there has to be a partner waiting for this one.
XOC, perhaps the update at the Biotech conference on Kevetrin..where exactly its at right now will let us know if it has a chance at getting anything in at ASCO at best it would have to be in the late breaking category. I would not be surprised if the company already is planning on Brilacidin-OM presentation there.
Here were my comments on that sad article:
Ben you shorted this just before the company Cellceutix is just about to give a comprehensive update on all their drug platforms at a Jan. 12 Biotech conference, not good Ben but then one can tell you really don't follow the company rather just shorted a stock that was moving up quickly.
Kevetrin: P53 reactivating drug could potentially treat over half the known cancers. Currently in late stage trial phase 1 at Harvard. This trial is already a success phase 2+ upcoming with proof of reactivation of p53 with elevated p21 at higher doses. Look for big break through here in pancreatic and colon cancers IMO.
Kevetrin: 1b/2 at University of Bologna for Leukemia at no cost to the company.
Kevetrin in renal cancer with Pfizer Sunitinib at Beth Israel Deaconess Medical Center where in preclinical work showed Kevetrin produced the first ever regression in resistant renal cancer. A SPORE grant will be paying for the human trials.
Brilacidin is part of a whole platform called defensin-mimetics which anti-infective drugs. Brilacidin just blew away top seller Daptomycin in a phase 2b trial where a one day dose of Brilacidin was comparable to a 7 day dose of Dapto in treatment of ABSSSI. This would be 100% patient compliance-HUGE! Brilacidin is a novel antibiotic of which none have been approved in the last 20 years! Brilacidin works by ripping off the plasma membrane of the bacteria....RESISTANCE will never have a chance to develop!
Brilacidin has just started a phase 2b trial for oral mucositis look for Break through status from the FDA here there is no other treatments for OM.
Cellceutix has made the compound stable at room temperature so they are now going after Diabetic foot infection $$$. Also planned trials for Brilacidin in otic and ocular applications. With the success in ABSSSI it bolds well for Brilacidin in all these other indications as well.
Oh, and there ~7 more compounds currently in the defensin-mimetics expect 2-3 trials to start here in 2015.
Oh yeah then there is Prurisol..but you probably already realized your mistake in shorting CTIX so I will let it end here.
Here is what I would like to have a update on from Nov. 11 2014:
"The trial is currently enrolling patients in the ninth cohort. Preliminary data show that 50 percent of patients treated with Kevetrin through the eighth cohort demonstrated enhancement in p21 expression in peripheral blood cells, and that these observations appeared dose-related. The biomarker p21 is tightly controlled by the tumor suppressor protein p53, which is often referred to as the “Guardian Angel Gene” because of its crucial role in controlling cell mutations. Initial comparisons between early and latter cohorts support Cellceutix’s expectations that p53 activation is dependent on extent of exposure to Kevetrin. These results support the hypothesis that Kevetrin has pharmacological activity in patients.
Kevetrin continues to be generally well-tolerated with no evidence of hematologic toxicity. One patient who received the highest dose of Kevetrin administered (350 mg/m2) experienced a dose-limiting toxicity (DLT). At the request of the patient and approval by the physician, the patient continues on the study, but at a reduced Kevetrin dose with no further DLT events. A maximum tolerated dose (MTD) has not been determined in this trial, to date"
- 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.s96mUYHF.dpuf
With dose-related p21 levels we should be able to crack the 50% enhancement in p21 levels at higher cohorts especially given the 10% threshold they put on p21 levels. I have been hoping for dose-related p21 levels statements for years now!
Familyman, I like your theory. A partnership perhaps with options A, B, C.... depending on the outcome of the FDA meeting. The company should have no problems partnering Brilacidin in ABSSSI one would think there would be a line.
Thanks for correcting the CSO's and CMO's. I am the CMJTO..Chief of Misinterpret Job Titles Officer the pay sucks but the job lets me crack in to my creative side =-).
I am thrilled with the addition of Dr. Jorgensen but what of our current CMO Dr. Menon?
Agreed Smitter, I think we move mostly sideways for a few more trading days then start to test $5 as we approach the Biotech conference.
Not many trading days till the Biotech conference. For those new to CTIX, investors conferences are a forum in which historically the company discloses more detailed information about their trials that they do not typically put in a PR. Of great interest among other things maybe Kevetrin!
Brilacidin for blood stream infections and others? If the FDA wants additional information on the MITT population??? Perhaps we can have a phase 3 for bacteremia patients with severe pneumonia, meningitis, diabetes etc. Daptomycin is approved in some of these:
Demonstrated clinical success as a first-line agent against MRSA and MSSA bacteremia, including right-sided endocarditis1
Clinical study included high-risk patient populations with diabetes, SIRS, injection-drug use, preexisting valvular heart disease, or recent surgery
CUBICIN (daptomycin for injection) is not indicated for the treatment of left-sided infective endocarditis due to S. aureus
Exhibits rapid bactericidal activity in vitro2,a
Sustains greater than 99.9% S. aureus isolate susceptibility in vitro3,a
More than 2.2 million patients treated3"
http://cubicin.com/?cid=ppc:google:cubicin:-
Brilacidin should be able to capture not only Daptomycin 1 billion annual market for ABSSSI but Vanomycin as well. One day treatment with a higher cure rate should be able to trump a generic. With a MOA of ripping off the plasma membrane of the bacteria, not ingested, broad usage of Brilacidin should be accepted because as the Borg 7 of 9 stated "resistance is futile".
The company does not control when their meeting is with the FDA and the FDA cares scrap about scheduling the meeting so Leo can issue a PR in a timely fashion to make all their investors rich. What I am sure of is that it is a set date that the company has known about for sometime so when Leo says he will update us in December then that is what I expect. I am also fairly certain that Leo may trip over himself trying to convey the information to investors ASAP.
Not into conspiracy theories..cold fusion is impossible.
Happy Holidays!
Long is long if your a flipper complaining about price action become a better flipper. The price isn't much of a concern now I am just following the news not the price action not the TA. Results will trump all!
Hound you know what they say "You can hear rumors. But you can't know them." Perhaps someday when Polyheist goes from 5 million to 5 billion or more Leo will elucidate on that....some day maybe soon.
I should say I too believe a buyout is possible at anytime. The buyer would IMO have to pay for so many drugs in development and the timing is not sync'd well with Brilacidin and Kevetrin development. Prefer partnering with Brilacidin ABSSSI to right the ship if you will and start sailing.
Yep, getting goose pumps for next week. Numerous items on the agenda PR-wise hopefully Leo does his end of the year detailed PR as well.
Hound curious why is it relevant who told the company about Polymed bankruptcy? Are you dropping a Thank You note?
The FDA meeting either has occurred or will occur in next few business days. My kids are going into winter break soon. PR early next week IMO.
Rolling, rolling, rolling
Cabel, I am connecting the two PRs. I think it's the same big pharma in both. A division of a big pharma wouldn't even have the right to test B if it were not the same big pharma that they already had a agreement with. Same big pharma in both PRs.
Cabel, the big pharma meeting a few months back I believe brought us the deal for the prophylactic use for B a few weeks ago. "A division of one of the largest U.S. pharmaceutical companies" if so they liked what they saw. I think we are really just waiting in the comments from the FDA before the deal can be struck.
Well we got to love all the big pharma love now for anitbiotics Durata and now Cubist. Merck just screwed up by not vetting but I doubt that will hinder other big pharma from scooping up these small antibiotic biotech companies. If Merck pulls out of this deal it should only make them hungrier. The government is putting so many perks on development and marketing now big pharma cannot refuse.
As far as Brilacidin ownership of patents was already vetted by the bankruptcy court(jump in Merck you don't have to think too much). IMO deal with B ABSSSI by 1st quarter 2015.
In these last two PRs where the company is conveying information to investors from the FDA the wording has been more concise with less color. The start date for Prurisol is not something they discussed with the FDA perhaps and hence was not commented on in the PR. I suspect all the PRs relaying information between the company and investors regarding comments from the FDA should be concise.
My take on today's PR. I think we passed a hurdle with the FDA in as far as abacavir having the same bioavailability as abacavir sulfate. The phase 1 trial of Prurisol was a success but that was not a certain if you look back at some of the past PR's on the subject there was some uncertainty in the wording from the company. So win there!
Also noted "Prurisol (abacavir) was the same or lower than that of the marketed drug Ziagen® (abacavir sulfate)" has the wording changed from a phase 2/3 study to phase 2 perhaps dose optimization trial based on the "lower" bioavailability. I think when company was stating prior to this PR phase 2/3 they meant phase 2b much like Kevetrin AML phase 1/2 is actually phase 1b. A phase 2 trial does not need to be broken up into 2a and 2b it can just be phase 2 in which case we would have lost no ground if the best outcome was just 2b.
The exciting news for me was this
"A potential application to market Prurisol will contain safety and efficacy data from studies conducted by Cellceutix, but at least some of the information required for approval may come from studies not conducted by Cellceutix. In this case, the long term safety data for Ziagen, marketed for over 15 years in the US, will be referenced."
Of course safety is paramount to the FDA. If the company runs a large enough phase 2 to prove efficacy this coupled with 15 years of safety data could lead to quick approval.
On the live ticker its at $4.15 with 1.2 million shares.
Wait a minute. Did we just get QIDP before we even met with the FDA? I am still trying to get my sleepy west coast eyes going. Someone at the FDA must have peeked at their CTIX notes.
I think B will be partnered up by the 1st quarter 2015.
Expect PR Monday regarding (at least) Merck buy out of Cubist's out for 7.5 billion! Amazing.. Brilacidin can do in 1 day what it took Cubist's Dapto 7 days to do. Dapto has been on the market a long time I know Cubist was doing one of those cheesy remake of the drug to ease generic fears but why in the world would Merck pay 7.5 B for that? We got a better B in ABSSSI and B in a whole lot of other things B-OM, B-Ocular, B-Otic, B-diabetic foot. Where sticking Brilacidin in your deep gashes, in your mouth, eyes, ears and feet. According to Merck Brilacidin alone is worth 10 billion???
Oh wait, our market cap. is 382 million ...OH COME ON MAN!
One of these days..
Yep,excited to hear FDA comments on B p2b.
Romad, I believe Leo really should talk to the FDA before any partners are considered.
Cabel, I noted that too.