CTIX News 11/08/2014 20:38:52 $CTIX
Gemzar was developed by Dr Menon while he worked at Eli Lilly.
The phase 1 trial end point of MTD is clearly defined as I had stated
If 1 patient out of 6 experiences a significant hematological consequence as defined at a particular dosing the MTD has been reached.
For Kevetrin this has yet to occur.
After 9 cohorts and 17 months no serious adverse effects have been documented.
Kevetrin is safe and there has been mention by Leo of efficacy at lower dosing.
Once MTD is reached they will enroll up to 12 more patients and try and reproduce the adverse effect and is at the discretion of the ethics committee at Dana Farber to terminate the trial.
Biodoc: Thanks for the explanation. I'm sure you're right that either fast track or breakthrough designation will be granted.
A few more questions --
The formulation for OM will be a topical. Do you know whether a new PI safety/dosage trial will be necessary?
It seems to me that the trial should consist only of treatment arms, perhaps different dosages or frequencies, rather than include a placebo. They'd rely on existing data or, should it be approved first, SGX942 numbers. Do you agree?
The more I learn about Brilacidin, the more it seems like a silver bullet. In the Cox interview with Dr. Menon, Menon was particularly animated when he spoke of B's immunomodulatory capability. A glance at the list of known autoimmune diseases that may be treatable with B could cause a swoon.
CTIX just cannot win for many of our current investors. All the preliminary data we have seen from the Kevetrin phase 1 trial has looked great to me. But a lot of investors just don't recognize it unless the stock goes surging up. They don't seem to be able to interrupt the news themselves and only recognize it as a success or failure based on the pps movement. To me the chance of a miracle gets brighter with every tidbit we get to them the light diminishes everyday.
I am still flipping my lid over Brilacidin 1-day treatment for ABSSSI. I have been on a lot of antibiotics in my 39 years. Never has it been for just one day and never has it been for something as serious as ABSSSI. Truly a game changer in progress and while the stock doubled in 2 months some investors say is that all? Or their must be something wrong with the numbers? And sell.
The company announces a shelf offering and I think "Welcome to the Big Leagues" and others say its a curse word and sell. In their view while they were vested in CTIX wouldn't the Aspire deal equal pure blasphemy.
Right now we are dominated retail flippers studying charts instead of interrupting news and low-brow MM's that work the OTC. That is why I am very excited about uplisting and drawing the attention of those how can interrupt the information other than the stock chart.
And all of that of course is IMO
I can tell you this, she's very fond of Leo as CEO. She owns the family business manufacturing company for heavens sakes and she works from home and plays on Facebook with her girlfriends all day......................must be nice.
I think the Brilacidin-OM Phase 2 clinical trial will move very quickly because (1) patient recruitment should be relatively easy (more like ABSSSI than Kevetrin) and (2) the duration of treatment is only 30 days. Also, B-OM will likely get Breakthrough designation (or at least fast track designation) in the coming months, greatly accelerating the approval path after the Phase 2 trial.
Quote:
Breakthrough therapy and fast track designation programs both are intended to expedite the development and review of drugs for serious or life-threatening conditions, but there are differences in what needs to be demonstrated to qualify for the programs. A breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies. In contrast, a fast track designation is for a drug that treats a serious or life-threatening condition, and nonclinical or clinical data demonstrate the potential to address unmet medical needs for the serious condition.
Breakthrough
The preclinical data for B-OM is remarkable. Severe oral mucositis was reduced by 94% with B-OM in animal models. In the head/neck cancer population where over 80% will get severe OM during treatment and there is no effective treatment, it won't take huge numbers of patients to identify study group (B-OM) vs. control (placebo).
As previously noted by SOX, Phase 2 trials for Soligenix' SGX942 is expected to take about one year (Dec. 2013-Dec. 2014). Soligenix has Fast Track designation from the FDA so this allows for a rolling NDA and priority review. SGX942 preclinical data shows reduction by 43%- really good considering the alternatives but nowhere near what we may see with B-OM. The drug looks very interesting but the treatment regimen is limited by several intravenous doses so patients get SGX942 for only a few days out of the 30 day chemo/radiation treatment period.
Great read. I look at these tumor markers as "trend monitors" and this is very nicely explained in your post. Thanks!
Ca 19-9. Funny you mentioned this. I was just reading about it last night.
Here's an ok read that may provide a little insight (for some) on tumor markers. Specifically CA 19-9.
//
Tumor Markers for Pancreatic Cancer
Tumor markers are just what they sound like, a way to mark a tumor. In other words, they can tell us, ideally, what a tumor is doing: growing or not growing.
You noticed I said, Ideally.
Exactly… there’s nothing ideal about the current tumor marker tests. But they’re all we’ve got right now and they are definitely better than nothing.
Let me explain the science behind them to make it a little clearer.
Most, if not all, cancers produce substances into our bodies. Some cancers produce proteins, some actually shed tumor cells. These substances can be found in either our blood, our urine, or in other body tissues. Tumor markers are tests to determine how much of these substances are floating around our body. The more tumor substance found in the body then it stands to reason, that the more active the cancer is. “Ideally.”
Unfortunately these tests are still a long way from being foolproof. There can be false positives and false negatives. Many other factors can alter the marker results, so most doctors use them as just one test among many to stage cancers and determine growth and advancement of the disease.
The most common tumor marker for pancreatic cancer is the CA 19-9. It was first developed to detect colon cancer, but has been found to also be sensitive for pancreatic cancer.
Ca 19-9 is a substance that is released into the blood by the pancreatic cancer cells. This marker test is performed by taking a small amount of blood and testing it.
A normal Ca 19-9 in a healthy individual can range from 0-37 U/ml. So anything higher than 37 should prompt a more thorough investigation. It sounds like a perfect screening test doesn’t it? Unfortunately, by the time blood levels are high enough to be consistently detected by this blood test, the cancer is usually in advanced stages. So, no, not a great screening test.
On the other hand, the Ca19-9 test is fairly accurate in evaluating how a patient is responding to the cancer treatment or chemotherapy. If the chemo is knocking back the cancer and slowing the growth, then the tumor won’t be shedding so much of the substance, resulting in lower Ca 19-9 figures. If the chemo is not working then obviously the tumor will be more active, shedding more substance, and having higher Ca 19-9 numbers.
One word of caution here. Don’t get caught in the trap of worrying over every spike in the marker test. Doctors generally are looking for trends over a period of time rather than one elevated test to determine success or failure of your treatment.
A second word of caution. There are a small number of people whose pancreatic cancers do not shed the Ca 19-9 substance. Their tumor marker test for Ca 19-9 will always come back low, irregardless of whether the cancer is growing or gone. If you fall into this group, your doctor will most likely opt for more frequent CT scans and evaluations to monitor your progress.
And finally, a third word of caution. (see what I mean? This tumor marker test is definitely not foolproof!). It’s important to know that the Ca 19-9 test can be elevated for other reasons besides pancreatic cancer. Among these are gallstones, pancreatitis (inflammation of the pancreas, not related to cancer), cirrhosis, and cholecystitis.
Mom is a good example of the erratic behavior of the Ca19-9 test. Her numbers have gone up and down like a roller coaster. Her initial tumor marker test was 404. Chemotherapy and radiation have gotten the test down at one point to a low of 84. But it’s been as high as 1474, after a 2 month hiatus from chemo due to a nasty gall bladder surgery. Her doctor uses the CA 19-9 test mainly to see how treatment is progressing. So far, the Gemzar keeps knocking the tumor marker back down. When the marker doesn’t respond to the chemo, we will know it’s time to move on to another treatment.
We’re thankful there are ways of monitoring mom’s cancer, even if the marker test is a tad unreliable. Certain cancers don’t even have that.
Funny, a year ago, being thankful for a blood test for cancer wasn’t even on my radar screen. So glad it was on the researcher’s. Who knows? In another decade maybe we’ll be light years ahead in detecting and monitoring pancreatic cancer. Praying that it will be so…
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?
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
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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
Gemzar was developed by Dr Menon while he worked at Eli Lilly.
The phase 1 trial end point of MTD is clearly defined as I had stated
If 1 patient out of 6 experiences a significant hematological consequence as defined at a particular dosing the MTD has been reached.
For Kevetrin this has yet to occur.
After 9 cohorts and 17 months no serious adverse effects have been documented.
Kevetrin is safe and there has been mention by Leo of efficacy at lower dosing.
Once MTD is reached they will enroll up to 12 more patients and try and reproduce the adverse effect and is at the discretion of the ethics committee at Dana Farber to terminate the trial.
Biodoc: Thanks for the explanation. I'm sure you're right that either fast track or breakthrough designation will be granted.
A few more questions --
The formulation for OM will be a topical. Do you know whether a new PI safety/dosage trial will be necessary?
It seems to me that the trial should consist only of treatment arms, perhaps different dosages or frequencies, rather than include a placebo. They'd rely on existing data or, should it be approved first, SGX942 numbers. Do you agree?
The more I learn about Brilacidin, the more it seems like a silver bullet. In the Cox interview with Dr. Menon, Menon was particularly animated when he spoke of B's immunomodulatory capability. A glance at the list of known autoimmune diseases that may be treatable with B could cause a swoon.
CTIX just cannot win for many of our current investors. All the preliminary data we have seen from the Kevetrin phase 1 trial has looked great to me. But a lot of investors just don't recognize it unless the stock goes surging up. They don't seem to be able to interrupt the news themselves and only recognize it as a success or failure based on the pps movement. To me the chance of a miracle gets brighter with every tidbit we get to them the light diminishes everyday.
I am still flipping my lid over Brilacidin 1-day treatment for ABSSSI. I have been on a lot of antibiotics in my 39 years. Never has it been for just one day and never has it been for something as serious as ABSSSI. Truly a game changer in progress and while the stock doubled in 2 months some investors say is that all? Or their must be something wrong with the numbers? And sell.
The company announces a shelf offering and I think "Welcome to the Big Leagues" and others say its a curse word and sell. In their view while they were vested in CTIX wouldn't the Aspire deal equal pure blasphemy.
Right now we are dominated retail flippers studying charts instead of interrupting news and low-brow MM's that work the OTC. That is why I am very excited about uplisting and drawing the attention of those how can interrupt the information other than the stock chart.
And all of that of course is IMO
I can tell you this, she's very fond of Leo as CEO. She owns the family business manufacturing company for heavens sakes and she works from home and plays on Facebook with her girlfriends all day......................must be nice.
I think the Brilacidin-OM Phase 2 clinical trial will move very quickly because (1) patient recruitment should be relatively easy (more like ABSSSI than Kevetrin) and (2) the duration of treatment is only 30 days. Also, B-OM will likely get Breakthrough designation (or at least fast track designation) in the coming months, greatly accelerating the approval path after the Phase 2 trial.
Quote:
Breakthrough therapy and fast track designation programs both are intended to expedite the development and review of drugs for serious or life-threatening conditions, but there are differences in what needs to be demonstrated to qualify for the programs. A breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies. In contrast, a fast track designation is for a drug that treats a serious or life-threatening condition, and nonclinical or clinical data demonstrate the potential to address unmet medical needs for the serious condition.
Breakthrough
The preclinical data for B-OM is remarkable. Severe oral mucositis was reduced by 94% with B-OM in animal models. In the head/neck cancer population where over 80% will get severe OM during treatment and there is no effective treatment, it won't take huge numbers of patients to identify study group (B-OM) vs. control (placebo).
As previously noted by SOX, Phase 2 trials for Soligenix' SGX942 is expected to take about one year (Dec. 2013-Dec. 2014). Soligenix has Fast Track designation from the FDA so this allows for a rolling NDA and priority review. SGX942 preclinical data shows reduction by 43%- really good considering the alternatives but nowhere near what we may see with B-OM. The drug looks very interesting but the treatment regimen is limited by several intravenous doses so patients get SGX942 for only a few days out of the 30 day chemo/radiation treatment period.
Great read. I look at these tumor markers as "trend monitors" and this is very nicely explained in your post. Thanks!
Ca 19-9. Funny you mentioned this. I was just reading about it last night.
Here's an ok read that may provide a little insight (for some) on tumor markers. Specifically CA 19-9.
//
Tumor Markers for Pancreatic Cancer
Tumor markers are just what they sound like, a way to mark a tumor. In other words, they can tell us, ideally, what a tumor is doing: growing or not growing.
You noticed I said, Ideally.
Exactly… there’s nothing ideal about the current tumor marker tests. But they’re all we’ve got right now and they are definitely better than nothing.
Let me explain the science behind them to make it a little clearer.
Most, if not all, cancers produce substances into our bodies. Some cancers produce proteins, some actually shed tumor cells. These substances can be found in either our blood, our urine, or in other body tissues. Tumor markers are tests to determine how much of these substances are floating around our body. The more tumor substance found in the body then it stands to reason, that the more active the cancer is. “Ideally.”
Unfortunately these tests are still a long way from being foolproof. There can be false positives and false negatives. Many other factors can alter the marker results, so most doctors use them as just one test among many to stage cancers and determine growth and advancement of the disease.
The most common tumor marker for pancreatic cancer is the CA 19-9. It was first developed to detect colon cancer, but has been found to also be sensitive for pancreatic cancer.
Ca 19-9 is a substance that is released into the blood by the pancreatic cancer cells. This marker test is performed by taking a small amount of blood and testing it.
A normal Ca 19-9 in a healthy individual can range from 0-37 U/ml. So anything higher than 37 should prompt a more thorough investigation. It sounds like a perfect screening test doesn’t it? Unfortunately, by the time blood levels are high enough to be consistently detected by this blood test, the cancer is usually in advanced stages. So, no, not a great screening test.
On the other hand, the Ca19-9 test is fairly accurate in evaluating how a patient is responding to the cancer treatment or chemotherapy. If the chemo is knocking back the cancer and slowing the growth, then the tumor won’t be shedding so much of the substance, resulting in lower Ca 19-9 figures. If the chemo is not working then obviously the tumor will be more active, shedding more substance, and having higher Ca 19-9 numbers.
One word of caution here. Don’t get caught in the trap of worrying over every spike in the marker test. Doctors generally are looking for trends over a period of time rather than one elevated test to determine success or failure of your treatment.
A second word of caution. There are a small number of people whose pancreatic cancers do not shed the Ca 19-9 substance. Their tumor marker test for Ca 19-9 will always come back low, irregardless of whether the cancer is growing or gone. If you fall into this group, your doctor will most likely opt for more frequent CT scans and evaluations to monitor your progress.
And finally, a third word of caution. (see what I mean? This tumor marker test is definitely not foolproof!). It’s important to know that the Ca 19-9 test can be elevated for other reasons besides pancreatic cancer. Among these are gallstones, pancreatitis (inflammation of the pancreas, not related to cancer), cirrhosis, and cholecystitis.
Mom is a good example of the erratic behavior of the Ca19-9 test. Her numbers have gone up and down like a roller coaster. Her initial tumor marker test was 404. Chemotherapy and radiation have gotten the test down at one point to a low of 84. But it’s been as high as 1474, after a 2 month hiatus from chemo due to a nasty gall bladder surgery. Her doctor uses the CA 19-9 test mainly to see how treatment is progressing. So far, the Gemzar keeps knocking the tumor marker back down. When the marker doesn’t respond to the chemo, we will know it’s time to move on to another treatment.
We’re thankful there are ways of monitoring mom’s cancer, even if the marker test is a tad unreliable. Certain cancers don’t even have that.
Funny, a year ago, being thankful for a blood test for cancer wasn’t even on my radar screen. So glad it was on the researcher’s. Who knows? In another decade maybe we’ll be light years ahead in detecting and monitoring pancreatic cancer. Praying that it will be so…
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?
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
