CTIX Alerts 11/08/2014 18:40:07 $CTIX
Hi Flash. I read his statement as being off as well.
It's defined on the clinical trials site as follows:
Primary Outcome Measures:
Maximum Tolerated Dose (MTD) of Kevetrin [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
A dose will be declared the MTD if at least 1 patient out of 6 patients experience a dose limiting toxicity (DLT) at the highest dose level below the maximally administered dose. Once an MTD has been established, up to 12 additional patients may be enrolled at the MTD dose level for confirmation of safety. The maximally administered dose is if 1 or more of 6 patients experience a DLT.
Dose Limiting Toxicities (DLT) of Kevetrin. [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]
The definition of dose limiting toxicity (DLT) is in accord with the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Dose limiting toxicity will be defined as:
Grade 3 or 4 neutropenia complicated by fever, or greater than 38.5°C documented infection, or Grade 4 neutropenia of greater than 7 days duration
Grade 4 thrombocytopenia or grade 3 thrombocytopenia complicated by hemorrhage
Any grade greater than 3 non-hematologic toxicity unless there is clear alternative evidence that the adverse event (AE) was not caused by Kevetrin
Grade 3 diarrhea, nausea, or vomiting may be excluded from dose-limiting toxicities provided that the maximum time limit for supportive measures is 48 hours.
http://clinicaltrials.gov/ct2/show/NCT0166400...amp;rank=2
Impressive that pancreatic tumor size remained stable for over 4 months. I suspect CA 19-9 levels were also monitored and I wonder if levels trended lower. CA 19-9 is more sensitive than CEA as a tumor marker for pancreatic cancer. Very encouraging- hope we hear more good news soon.
Are you sure it is "in line." I read Dr J's version as the final stage actually attempts to cause someone to have an SAE. Not sure that is ethical.
You crack me up etrade.
Have a good night! Shalom.
CEA tumor marker is something that both my wife and mother lived and died by with both of their cancers which were non-small cell lung. In fact, any cancer patient will tell you exactly what it means. Leo's citing this pancreatic instance is huge and I only hope that it can be replicated for those afflicted with this extremely deadly form of cancer.
Nothing but good news here, have a great night.
GO CTIX!!!!!!!
Quote:
Once the MTD is established, the trial will enroll another 12 patients who meet the criteria and will look for at least 1 out of 6 to determine if any grade 3 or 4 adverse effects are observed.
If they can reproduce this the trial will be declared over.
Let me start by saying I about fell out of my F'in chair when you posted this. It's inline with what most here have been saying for some time now. I'm shell shocked.
Tell me if you agree with the following: The maximum administered dose is defined when 1 out of 6 patients experience a dose limiting toxicity. The trial then enrolls up to 12 (probably 3) more patients at the lower dosing level defined as the Maximum Tolerated Dose to confirm safety at this lower dosing level. Safety is confirmed if no dose limiting toxicity occurs at the maximum tolerated dose.
>>"Another tumor marker, CEA, was decreased and the tumor size remained stable over 4 months in a pancreatic carcinoma patient...."
I missed the above the first few times I saw the whole release. The above data point is from doses <210 mg/m2. There is now data at 210 and hopefully 350.
That is a stage 4 pancreatic cancer with a prognosis of 6 months to a year. The tumor size stabilized for 4 months would be considered a breakthrough treatment if confirmed in more patients of that tumor type. If K stabilizes growth for a cancer for which there is no other effective treatment, it will be approved as a stand alone cancer drug.
K - CTIX - Old SA article
http://m.seekingalpha.com/article/1422381-cel...ved?page=2
An old seeking alpha very informative article on Kevetrin and CTIX.
This is the article that made me invest more in CTIX some 1 1/2 years back.
We have come a long way and Kevetrin has progressed further - to C9. Hoping that some of the things said in that article come true.
The comments and the debate on this article also gives a lot of info
Cellceutix Corporation: The Next Generation Of Cancer Tr...
For decades, humanity has fought the war against cancer with a shared common purpose and a mutual hope for victory over an advanced and constantly evolving enem...
View on seekingalpha.com
Preview by Yahoo
You can add me as an honorary member to the family and I'd be ....honored of course.
Yes we can all agree that CTIX has a lot good going on. Invest heavily and be unimaginably rewarded.
Thanks for the response.
Thanks Dr J, that explained a lot for me.
Personally I am encouraged by these low-dose results, but given the low sample size and that the nature of cancer pathology is that it can wax and wane on its own, I can draw no conclusions on efficacy. Thank goodness for the scientific process of drug trials: it's what Phase 2 and 3 trials are for!
Gee, one monsta whale among others come to mind and it's certainly not me.............................where's biohedge?
Yes George is dangerously definitive even in the face of contradicting statements from the company itself and from the resident docs on this board. Time will tell and it is not in his financial interest to be completely correct. (Which is the only reason I have some minuscule remnant of respect for his opinion.)
Nice!
I've got 4 ophthalmic surgeons in the immediate family and all three of them have bought into CTIX. They're very enthusiastic about B-Ocular, along with everything else. (FWIW the pediatrician and the oncology nurse practitioner are in, too. Oh, and the Morgan Stanley private wealth manager
God Bless you, I'll tell her tonight about your Cellceutix thoughts as we celebrate the Sabbath, she'll like that, a divine appointment........................All the best to you and yours, Shalom.
Thanks Citrati. I think TA can have temporary validity if enough people in the market agree on a 'trend' and trade accordingly. But it has been mathematically proven that such a phenomenon would not be sustainable, just as a cartel or a ponzi scheme or a Martingale system for roulette is not sustainable; it will ultimately fail. And note just the onerous initial conditionality: first you have to assume everyone agrees on the TA pattern. Open up 10 newspapers and find 10 horoscopes for Libra. Ever notice none of them are the same?
And to push any remaining doubt aside: Do you buy CTIX because it is in a channel? Or an inverted flag pattern, or head and shoulder or whatever? Or because you assessed its potential future free cash flows and thought it is still undervalued?
Finally: all the successful investors you can name are fundamental analysts, not TA's. There is a reason for that.
I look at CTIX's stock chart. I absolutely do. And I knew CTIX would have a pullback. Of course it will. And it will again many, many times. But what I do not know, and no one here knows either, is when and how much.
Having a cancer cure / stabilization / reduction will bring so many good feelings to those who have cancer, and their loved ones-priceless-and it will be reflected in the stock price.
I live in the doghouse around here. And sometimes I think she loves Leo more than me, LOL. Seriously, she loved the letter to Shareholders but other than that she only follows what I share, PR's. Her sister passed from breast cancer at a very early age, and she wants and prays for a miracle cure/drug for others in her heart. She prays Cellceutix will achieve it. From 1.75, the law was laid, "Don't ever sell my shares, it will be a heritage for my sister, I have the faith" and the rest is history......................................Shalom.
Hot Stocks to Follow for Investment Opportunity & Special Profile "InvestorsHub NewsWire" - 11/6/2014 6:00:00 AM
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
Hi Flash. I read his statement as being off as well.
It's defined on the clinical trials site as follows:
Primary Outcome Measures:
Maximum Tolerated Dose (MTD) of Kevetrin [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
A dose will be declared the MTD if at least 1 patient out of 6 patients experience a dose limiting toxicity (DLT) at the highest dose level below the maximally administered dose. Once an MTD has been established, up to 12 additional patients may be enrolled at the MTD dose level for confirmation of safety. The maximally administered dose is if 1 or more of 6 patients experience a DLT.
Dose Limiting Toxicities (DLT) of Kevetrin. [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]
The definition of dose limiting toxicity (DLT) is in accord with the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Dose limiting toxicity will be defined as:
Grade 3 or 4 neutropenia complicated by fever, or greater than 38.5°C documented infection, or Grade 4 neutropenia of greater than 7 days duration
Grade 4 thrombocytopenia or grade 3 thrombocytopenia complicated by hemorrhage
Any grade greater than 3 non-hematologic toxicity unless there is clear alternative evidence that the adverse event (AE) was not caused by Kevetrin
Grade 3 diarrhea, nausea, or vomiting may be excluded from dose-limiting toxicities provided that the maximum time limit for supportive measures is 48 hours.
http://clinicaltrials.gov/ct2/show/NCT0166400...amp;rank=2
Impressive that pancreatic tumor size remained stable for over 4 months. I suspect CA 19-9 levels were also monitored and I wonder if levels trended lower. CA 19-9 is more sensitive than CEA as a tumor marker for pancreatic cancer. Very encouraging- hope we hear more good news soon.
Are you sure it is "in line." I read Dr J's version as the final stage actually attempts to cause someone to have an SAE. Not sure that is ethical.
You crack me up etrade.
Have a good night! Shalom. CEA tumor marker is something that both my wife and mother lived and died by with both of their cancers which were non-small cell lung. In fact, any cancer patient will tell you exactly what it means. Leo's citing this pancreatic instance is huge and I only hope that it can be replicated for those afflicted with this extremely deadly form of cancer.
Nothing but good news here, have a great night.
GO CTIX!!!!!!!
Quote:
Once the MTD is established, the trial will enroll another 12 patients who meet the criteria and will look for at least 1 out of 6 to determine if any grade 3 or 4 adverse effects are observed.
If they can reproduce this the trial will be declared over.
Let me start by saying I about fell out of my F'in chair when you posted this. It's inline with what most here have been saying for some time now. I'm shell shocked.
Tell me if you agree with the following: The maximum administered dose is defined when 1 out of 6 patients experience a dose limiting toxicity. The trial then enrolls up to 12 (probably 3) more patients at the lower dosing level defined as the Maximum Tolerated Dose to confirm safety at this lower dosing level. Safety is confirmed if no dose limiting toxicity occurs at the maximum tolerated dose.
>>"Another tumor marker, CEA, was decreased and the tumor size remained stable over 4 months in a pancreatic carcinoma patient...."
I missed the above the first few times I saw the whole release. The above data point is from doses <210 mg/m2. There is now data at 210 and hopefully 350.
That is a stage 4 pancreatic cancer with a prognosis of 6 months to a year. The tumor size stabilized for 4 months would be considered a breakthrough treatment if confirmed in more patients of that tumor type. If K stabilizes growth for a cancer for which there is no other effective treatment, it will be approved as a stand alone cancer drug.
K - CTIX - Old SA article
http://m.seekingalpha.com/article/1422381-cel...ved?page=2
An old seeking alpha very informative article on Kevetrin and CTIX.
This is the article that made me invest more in CTIX some 1 1/2 years back.
We have come a long way and Kevetrin has progressed further - to C9. Hoping that some of the things said in that article come true.
The comments and the debate on this article also gives a lot of info
Cellceutix Corporation: The Next Generation Of Cancer Tr...
For decades, humanity has fought the war against cancer with a shared common purpose and a mutual hope for victory over an advanced and constantly evolving enem...
View on seekingalpha.com
Preview by Yahoo
You can add me as an honorary member to the family and I'd be ....honored of course.
Yes we can all agree that CTIX has a lot good going on. Invest heavily and be unimaginably rewarded.
Thanks for the response.
Thanks Dr J, that explained a lot for me.
Personally I am encouraged by these low-dose results, but given the low sample size and that the nature of cancer pathology is that it can wax and wane on its own, I can draw no conclusions on efficacy. Thank goodness for the scientific process of drug trials: it's what Phase 2 and 3 trials are for!
Gee, one monsta whale among others come to mind and it's certainly not me.............................where's biohedge?
Yes George is dangerously definitive even in the face of contradicting statements from the company itself and from the resident docs on this board. Time will tell and it is not in his financial interest to be completely correct. (Which is the only reason I have some minuscule remnant of respect for his opinion.)
Nice!
I've got 4 ophthalmic surgeons in the immediate family and all three of them have bought into CTIX. They're very enthusiastic about B-Ocular, along with everything else. (FWIW the pediatrician and the oncology nurse practitioner are in, too. Oh, and the Morgan Stanley private wealth manager
God Bless you, I'll tell her tonight about your Cellceutix thoughts as we celebrate the Sabbath, she'll like that, a divine appointment........................All the best to you and yours, Shalom.
Thanks Citrati. I think TA can have temporary validity if enough people in the market agree on a 'trend' and trade accordingly. But it has been mathematically proven that such a phenomenon would not be sustainable, just as a cartel or a ponzi scheme or a Martingale system for roulette is not sustainable; it will ultimately fail. And note just the onerous initial conditionality: first you have to assume everyone agrees on the TA pattern. Open up 10 newspapers and find 10 horoscopes for Libra. Ever notice none of them are the same?
And to push any remaining doubt aside: Do you buy CTIX because it is in a channel? Or an inverted flag pattern, or head and shoulder or whatever? Or because you assessed its potential future free cash flows and thought it is still undervalued?
Finally: all the successful investors you can name are fundamental analysts, not TA's. There is a reason for that.
I look at CTIX's stock chart. I absolutely do. And I knew CTIX would have a pullback. Of course it will. And it will again many, many times. But what I do not know, and no one here knows either, is when and how much.
Having a cancer cure / stabilization / reduction will bring so many good feelings to those who have cancer, and their loved ones-priceless-and it will be reflected in the stock price.
I live in the doghouse around here. And sometimes I think she loves Leo more than me, LOL. Seriously, she loved the letter to Shareholders but other than that she only follows what I share, PR's. Her sister passed from breast cancer at a very early age, and she wants and prays for a miracle cure/drug for others in her heart. She prays Cellceutix will achieve it. From 1.75, the law was laid, "Don't ever sell my shares, it will be a heritage for my sister, I have the faith" and the rest is history......................................Shalom.
Hot Stocks to Follow for Investment Opportunity & Special Profile "InvestorsHub NewsWire" - 11/6/2014 6:00:00 AM
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
