CTIX Company info 11/01/2014 22:19:31 $CTIX
The CEO of Polymedix made similar comments over 2 years ago:
Quote:
"PMX-30063, now referred to as brilacidin, is the first compound in the new cidin class of antibiotics," commented Nicholas Landekic, President and CEO of PolyMedix. "The cidins are unlike any other class of systemic antibiotic approved or in development. They imitate how our body's own immune system combats bacterial infections. Brilacidin, our lead clinical compound, kills bacteria that are resistant to other antibiotic classes, with a mechanism to which resistance is unlikely to develop. ---Polymedix PR June 12, 2012
It's 2 years later "and many people still don't fully grasp," but being a slow learner to this game will be costly.
http://www.globenewswire.com/news-release/201...30063.html
That's the first I've heard that on the board. I just re-read the Aug 7 PR and I didn't get a sense of disappointment or anything indicating suspicion of failure. Unless there are any errors found or procedural objections before data release, it sounds to me like P passed.
"What I see — and what I think many people still don’t fully grasp — is that Brilacidin is not just a potential blockbuster for the indication of ABSSSI, including infections caused by MRSA, but this trial provides proof-of-efficacy data for defensin-mimetics as a novel class of antimicrobials that may be used to treat a broad array of diseases and conditions with a very limited chance for drug resistance to develop." - Dr. James Alexander, COO of CTIX
Very pleased with the initial communication from the COO... sounds like a great addition to the team... good to know that Dr. Alexander can help run the show... especially since Leo could get arrested any day now for stealing those PolyMed assets right out from under the noses of big pharma...
A pass on partnership at this time may very well speak volumes as to how research and development, ongoing trials, and concluded trial results are being perceived by CTIX management. These guys know so much more than has been PR'd. The better the current state of affairs and prospects for approval of multi-billion dollar drugs the less urgency to jump at the first offer for financial security. I like your reasoning and thinking. And I love the potential list of trials within a year. Imagine the number of PR's coming from that many active trials.
Absolutely! As in "steal" a HUGE MAJORITY of that $7.3 billion market. Then on top of that add the B and K platforms. CTIX is going to be a MONSTER - the stock of the century. Thank you Patrick Cox for introducing me to CTIX!
Quote:
I would imagine if prurisol was approved and at this juncture, i have no reason to believe otherwise. Prurisol should be able to come in to the market and steal a huge share of the market if it does indeed act as a cure vice a maintenance treatment? - jok
Prurisol is not a "biologic" and it won't be cheap.
Celgene is keeping a very close eye on this drug and may partner up with CTIX.
Leo knows the VP of Celgene very well
Celgene has 8 billion is cash and has the infrastructure to take this one all the way.
Celgene's psoriasis drug is performing poorly.
I would imagine if prurisol was approved and at this juncture, i have no reason to believe otherwise. Prurisol should be able to come in to the market and steal a huge share of the market if it does indeed act as a cure vice a maintenance treatment?
JOK,
I was doing some DD and was about to post these quotes. I just saw your last post covered this, but hated to waste the effort.
"Biologics are potent psoriasis treatments. They work well to treat moderate or severe psoriasis, says Mark Lebwohl, MD, chairman of the National Psoriasis Foundation Medical Board, and he says he prefers them over other psoriasis drugs.
But they also have two key drawbacks:
Biologic drugs are expensive. Depending on the drug and the dose, they can cost $10,000 to $30,000 a year.
Biologics suppress the immune system. That means they can increase the risk for infection.
Almost 7.5 million people in the U.S. have a form of psoriasis. Celebrities such as TV personality Kim Kardashian, singer LeAnn Rimes, and swimmer Dara Torres all have it."
http://www.webmd.com/skin-problems-and-treatm.../biologics
" Between 2000 and 2008, the average wholesale price of five popular psoriasis drugs increased at a rate nearly five times that of inflation, according to a study published earlier this year in the Archives of Dermatology. During that period, the price of a dose of Enbrel increased by nearly 50%, to about $208; a dose of Humira increased to $831"
http://www.health.com/health/condition-articl...22,00.html
And our 18.00 2015 price target will certainly fit that bill. Cellceutix patience required grasshopper.........................Leo is boss (adjective).
worldwide psoriasis market
http://www.prweb.com/releases/psoriasis_drugs...855734.htm
https://secure.marketwatch.com/story/cellceut...2014-08-08
Even, I agree with you both and still feel as I felt back when, that they already know the answer on P and probably have pictures locked away in a safe in a far away land. Tehe.
GO CTIX
Looks like someone missed yesterday's PR.
"I believe the safety profile of Kevetrin has been very well evaluated in the current trial and is reassuring when Kevetrin is used a single agent and potentially in combination with other therapy."
Notice that the word "potentially" is not used in front of "a single agent" but is used in front of "in combination". Insiders know a lot more facts than us outsiders. You should believe that.
Quote:
I believe that you should NOT expect any miracles from Kevetrin as a single agent. I hope that I am wrong about Kevetrin but I strongly suspect I am right on target based on all the FACTS current made public.
I'm not sure either, but Leo did say it was pretty much a given. That's all I really need.
That depends on the size of the study. But, this will be a fairly quick trial similar to Brilacidin with only a few months of follow on data for each patient. It could range between 300 and 1000 patients, but it would be recruitment reaching out to other clinics, and not be ITT cases unless they were going for uncontrolled cases which would qualify for accelerated review under unmet need.
The primary endpoint, conversion to Abacavir, was met and the company has completed the design of a Phase 2/3a trial. That was announced, or so I thought. They will meet soon with the FDA for guidance, if they have not already met.
Listen to 6:00 to 6:20:
http://cellceutix.com/wp-content/uploads/2014...rt-2-1.mp3
I'm praying that the reason the official data has not been disclosed as of yet, is that CTIX wants to tell us that not only was the P1 endpoints realized, but we have a green light for a P2/3 trial.
Your post brings back memories of how excited we all were for Prurisol before the Polymedix heist.
Question,... if they are able to start the Prurisol trial sometime in Q1 of 2015,... in your opinion,.. would there be any possibility we would have Top-Line data before the end of 2015,...?
Thanks!
Quote:
I think the medium dose would have produced the same results but it seems some of the patients didn't come back for evaluation.
Exactly. They didn't come back because either they were cured or they died. If they had died the PI would have followed up with that in the Phase 2a report. So, we can assume they were cured which would bring the results for the medium dose to ~95.
Securities Registration Statement (simplified Form) (s-3) "Edgar (US Regulatory)" - 10/30/2014 4:31:15 PM
Current Report Filing (8-k) "Edgar (US Regulatory)" - 10/24/2014 6:04:28 AM
ALTITRADE PARTNERS™ SAYS A KEY-REVERSAL DAY COULD HAPPEN THIS WEEK "InvestorsHub NewsWire" - 10/14/2014 6:00:00 AM
Current Report Filing (8-k) "Edgar (US Regulatory)" - 9/24/2014 3:48:22 PM
Annual Report (10-k) "Edgar (US Regulatory)" - 9/15/2014 1:50:04 PM
Statement of Ownership (sc 13g) "Edgar (US Regulatory)" - 9/4/2014 4:14:23 PM
Current Report Filing (8-k) "Edgar (US Regulatory)" - 9/2/2014 6:29:26 AM
Cellceutix Anti-Fungal Compounds Awarded $1.5 Million SBIR Grant "Marketwired" - 6/23/2014 7:00:00 AM
Cellceutix Clinical Trial of Anti-Cancer Drug Kevetrin Entering Eighth Cohort "Marketwired" - 6/16/2014 7:00:00 AM
Cellceutix Completes Patient Enrollment in Clinical Trial of Prurisol "Marketwired" - 6/2/2014 7:00:00 AM
Cellceutix Signs Material Transfer Agreements for Defensin Mimetic Compounds With Leading Universities "Marketwired" - 5/27/2014 7:00:00 AM
Cellceutix Plans for Entry in Diabetic Foot Wound and Ulcer Market "Marketwired" - 5/19/2014 7:00:00 AM
Amended Quarterly Report (10-q/a) "Edgar (US Regulatory)" - 5/16/2014 11:57:54 AM
Quarterly Report (10-q) "Edgar (US Regulatory)" - 5/12/2014 10:12:29 AM
Cellceutix Confident in Its Formidable Antibiotic Arsenal "Marketwired" - 5/12/2014 7:00:00 AM
Cohort Completed in Cellceutix Clinical Trial of Prurisol for Psoriasis "Marketwired" - 5/5/2014 9:53:20 AM
Study Shows Cellceutix Antibiotic Active Against Drug-Resistant Superbug Klebsiella Pneumoniae "Marketwired" - 4/14/2014 6:30:00 AM
Cellceutix Comments on Positive FDA Advisory Vote for Dalbavancin and Tedizolid "Marketwired" - 4/1/2014 8:00:00 AM
Cellceutix Reports 20 Percent Enrollment Completed in Phase 2b Trial of Brilacidin as Short-Course Therapy for ABSSSI "Marketwired" - 3/31/2014 9:25:00 AM
Cellceutix Initiates Clinical Trial of Prurisol as New Treatment for Psoriasis "Marketwired" - 3/25/2014 6:00:00 AM
Cellceutix to Initiate Psoriasis Clinical Trial "Marketwired" - 3/21/2014 6:00:00 AM
Seventh Cohort Underway in Cellceutix Clinical Trial of Kevetrin for Solid Tumors "Marketwired" - 3/19/2014 8:40:37 AM
Cellceutix Reports 14 Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Patients Treated in Phase 2b Clinical Trial "Marketwired" - 3/10/2014 6:00:00 AM
Cellceutix Expands to Gram-Negative Bacterial Infections "Marketwired" - 3/5/2014 6:00:00 AM
Cellceutix Enrolls First Patients in Phase 2b ABSSSI Clinical Trial "Marketwired" - 2/26/2014 6:00:00 AM
The CEO of Polymedix made similar comments over 2 years ago:
Quote:
"PMX-30063, now referred to as brilacidin, is the first compound in the new cidin class of antibiotics," commented Nicholas Landekic, President and CEO of PolyMedix. "The cidins are unlike any other class of systemic antibiotic approved or in development. They imitate how our body's own immune system combats bacterial infections. Brilacidin, our lead clinical compound, kills bacteria that are resistant to other antibiotic classes, with a mechanism to which resistance is unlikely to develop. ---Polymedix PR June 12, 2012
It's 2 years later "and many people still don't fully grasp," but being a slow learner to this game will be costly.
http://www.globenewswire.com/news-release/201...30063.html
That's the first I've heard that on the board. I just re-read the Aug 7 PR and I didn't get a sense of disappointment or anything indicating suspicion of failure. Unless there are any errors found or procedural objections before data release, it sounds to me like P passed.
"What I see — and what I think many people still don’t fully grasp — is that Brilacidin is not just a potential blockbuster for the indication of ABSSSI, including infections caused by MRSA, but this trial provides proof-of-efficacy data for defensin-mimetics as a novel class of antimicrobials that may be used to treat a broad array of diseases and conditions with a very limited chance for drug resistance to develop." - Dr. James Alexander, COO of CTIX
Very pleased with the initial communication from the COO... sounds like a great addition to the team... good to know that Dr. Alexander can help run the show... especially since Leo could get arrested any day now for stealing those PolyMed assets right out from under the noses of big pharma...
A pass on partnership at this time may very well speak volumes as to how research and development, ongoing trials, and concluded trial results are being perceived by CTIX management. These guys know so much more than has been PR'd. The better the current state of affairs and prospects for approval of multi-billion dollar drugs the less urgency to jump at the first offer for financial security. I like your reasoning and thinking. And I love the potential list of trials within a year. Imagine the number of PR's coming from that many active trials.
Absolutely! As in "steal" a HUGE MAJORITY of that $7.3 billion market. Then on top of that add the B and K platforms. CTIX is going to be a MONSTER - the stock of the century. Thank you Patrick Cox for introducing me to CTIX!
Quote:
I would imagine if prurisol was approved and at this juncture, i have no reason to believe otherwise. Prurisol should be able to come in to the market and steal a huge share of the market if it does indeed act as a cure vice a maintenance treatment? - jok
Prurisol is not a "biologic" and it won't be cheap.
Celgene is keeping a very close eye on this drug and may partner up with CTIX.
Leo knows the VP of Celgene very well
Celgene has 8 billion is cash and has the infrastructure to take this one all the way.
Celgene's psoriasis drug is performing poorly.
I would imagine if prurisol was approved and at this juncture, i have no reason to believe otherwise. Prurisol should be able to come in to the market and steal a huge share of the market if it does indeed act as a cure vice a maintenance treatment?
JOK,
I was doing some DD and was about to post these quotes. I just saw your last post covered this, but hated to waste the effort.
"Biologics are potent psoriasis treatments. They work well to treat moderate or severe psoriasis, says Mark Lebwohl, MD, chairman of the National Psoriasis Foundation Medical Board, and he says he prefers them over other psoriasis drugs.
But they also have two key drawbacks:
Biologic drugs are expensive. Depending on the drug and the dose, they can cost $10,000 to $30,000 a year.
Biologics suppress the immune system. That means they can increase the risk for infection.
Almost 7.5 million people in the U.S. have a form of psoriasis. Celebrities such as TV personality Kim Kardashian, singer LeAnn Rimes, and swimmer Dara Torres all have it."
http://www.webmd.com/skin-problems-and-treatm.../biologics
" Between 2000 and 2008, the average wholesale price of five popular psoriasis drugs increased at a rate nearly five times that of inflation, according to a study published earlier this year in the Archives of Dermatology. During that period, the price of a dose of Enbrel increased by nearly 50%, to about $208; a dose of Humira increased to $831"
http://www.health.com/health/condition-articl...22,00.html
And our 18.00 2015 price target will certainly fit that bill. Cellceutix patience required grasshopper.........................Leo is boss (adjective).
worldwide psoriasis market
http://www.prweb.com/releases/psoriasis_drugs...855734.htm
https://secure.marketwatch.com/story/cellceut...2014-08-08
Even, I agree with you both and still feel as I felt back when, that they already know the answer on P and probably have pictures locked away in a safe in a far away land. Tehe.
GO CTIX
Looks like someone missed yesterday's PR.
"I believe the safety profile of Kevetrin has been very well evaluated in the current trial and is reassuring when Kevetrin is used a single agent and potentially in combination with other therapy."
Notice that the word "potentially" is not used in front of "a single agent" but is used in front of "in combination". Insiders know a lot more facts than us outsiders. You should believe that.
Quote:
I believe that you should NOT expect any miracles from Kevetrin as a single agent. I hope that I am wrong about Kevetrin but I strongly suspect I am right on target based on all the FACTS current made public.
I'm not sure either, but Leo did say it was pretty much a given. That's all I really need.
That depends on the size of the study. But, this will be a fairly quick trial similar to Brilacidin with only a few months of follow on data for each patient. It could range between 300 and 1000 patients, but it would be recruitment reaching out to other clinics, and not be ITT cases unless they were going for uncontrolled cases which would qualify for accelerated review under unmet need.
The primary endpoint, conversion to Abacavir, was met and the company has completed the design of a Phase 2/3a trial. That was announced, or so I thought. They will meet soon with the FDA for guidance, if they have not already met.
Listen to 6:00 to 6:20:
http://cellceutix.com/wp-content/uploads/2014...rt-2-1.mp3
I'm praying that the reason the official data has not been disclosed as of yet, is that CTIX wants to tell us that not only was the P1 endpoints realized, but we have a green light for a P2/3 trial.
Your post brings back memories of how excited we all were for Prurisol before the Polymedix heist.
Question,... if they are able to start the Prurisol trial sometime in Q1 of 2015,... in your opinion,.. would there be any possibility we would have Top-Line data before the end of 2015,...?
Thanks!
Quote:
I think the medium dose would have produced the same results but it seems some of the patients didn't come back for evaluation.
Exactly. They didn't come back because either they were cured or they died. If they had died the PI would have followed up with that in the Phase 2a report. So, we can assume they were cured which would bring the results for the medium dose to ~95.
Securities Registration Statement (simplified Form) (s-3) "Edgar (US Regulatory)" - 10/30/2014 4:31:15 PM
Current Report Filing (8-k) "Edgar (US Regulatory)" - 10/24/2014 6:04:28 AM
ALTITRADE PARTNERS™ SAYS A KEY-REVERSAL DAY COULD HAPPEN THIS WEEK "InvestorsHub NewsWire" - 10/14/2014 6:00:00 AM
Current Report Filing (8-k) "Edgar (US Regulatory)" - 9/24/2014 3:48:22 PM
Annual Report (10-k) "Edgar (US Regulatory)" - 9/15/2014 1:50:04 PM
Statement of Ownership (sc 13g) "Edgar (US Regulatory)" - 9/4/2014 4:14:23 PM
Current Report Filing (8-k) "Edgar (US Regulatory)" - 9/2/2014 6:29:26 AM
Cellceutix Anti-Fungal Compounds Awarded $1.5 Million SBIR Grant "Marketwired" - 6/23/2014 7:00:00 AM
Cellceutix Clinical Trial of Anti-Cancer Drug Kevetrin Entering Eighth Cohort "Marketwired" - 6/16/2014 7:00:00 AM
Cellceutix Completes Patient Enrollment in Clinical Trial of Prurisol "Marketwired" - 6/2/2014 7:00:00 AM
Cellceutix Signs Material Transfer Agreements for Defensin Mimetic Compounds With Leading Universities "Marketwired" - 5/27/2014 7:00:00 AM
Cellceutix Plans for Entry in Diabetic Foot Wound and Ulcer Market "Marketwired" - 5/19/2014 7:00:00 AM
Amended Quarterly Report (10-q/a) "Edgar (US Regulatory)" - 5/16/2014 11:57:54 AM
Quarterly Report (10-q) "Edgar (US Regulatory)" - 5/12/2014 10:12:29 AM
Cellceutix Confident in Its Formidable Antibiotic Arsenal "Marketwired" - 5/12/2014 7:00:00 AM
Cohort Completed in Cellceutix Clinical Trial of Prurisol for Psoriasis "Marketwired" - 5/5/2014 9:53:20 AM
Study Shows Cellceutix Antibiotic Active Against Drug-Resistant Superbug Klebsiella Pneumoniae "Marketwired" - 4/14/2014 6:30:00 AM
Cellceutix Comments on Positive FDA Advisory Vote for Dalbavancin and Tedizolid "Marketwired" - 4/1/2014 8:00:00 AM
Cellceutix Reports 20 Percent Enrollment Completed in Phase 2b Trial of Brilacidin as Short-Course Therapy for ABSSSI "Marketwired" - 3/31/2014 9:25:00 AM
Cellceutix Initiates Clinical Trial of Prurisol as New Treatment for Psoriasis "Marketwired" - 3/25/2014 6:00:00 AM
Cellceutix to Initiate Psoriasis Clinical Trial "Marketwired" - 3/21/2014 6:00:00 AM
Seventh Cohort Underway in Cellceutix Clinical Trial of Kevetrin for Solid Tumors "Marketwired" - 3/19/2014 8:40:37 AM
Cellceutix Reports 14 Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Patients Treated in Phase 2b Clinical Trial "Marketwired" - 3/10/2014 6:00:00 AM
Cellceutix Expands to Gram-Negative Bacterial Infections "Marketwired" - 3/5/2014 6:00:00 AM
Cellceutix Enrolls First Patients in Phase 2b ABSSSI Clinical Trial "Marketwired" - 2/26/2014 6:00:00 AM
