CTIX Stock Alert 08/17/2014 05:27:08 $CTIX
Read then think!!!
"...Prior data is in favor of Kevetrin showing enough safety so that I think the Phase I trial, when completed, will advance the compound and the stock. Here I have taken a careful look at the numbers published previously. With Kevetrin, the situation is the opposite of Prurisol. There is a greater reason to be confident about effectiveness. The unknown is toxicity. One of the facts that stands out when one peruses the reported Phase I data is that the first cohort was started at a very low dose compared to that in the reported pre-clinical studies. The beginning low dose makes sense when this is the first use in a live human of a new compound. However, we wonder if and when it will get to concentrations enough to produce therapeutic benefit. As has been pointed out on forums elsewhere, the beginning dose for the Dana-Farber trial was only a 60th of the dose used to generate the positive pre-clinical data (200mg/kg in mice) reported. Also, the pre-clinical studies employed intraperitoneal administration and the Phase I study uses iv infusion. The two modes of administration are likely to be associated with different effects in regard to drug behavior and distribution, as well as toxicity.
Dosage is considered better correlated to body surface area, and that is how the Phase I dosage has been reported. The first round was 10mg/m2. The relationship between mg/kg and BSA in various animals and people has been worked out (FASEB J. 22, 659-661 [2007]) and 200mg/kg in mice corresponds to 600 mg/m2 in humans. Here are two big questions to which we should find the answer when the Phase I trial is complete and results are reported: can patients tolerate a dose of 600mg/m2, and is that high a dose necessary for effectiveness? Will Kevetrin have anti-cancer effect at doses at which adverse effects are tolerable for the majority of patients? Here I find the following reported toxicity to dogs and rats to be encouraging.
A GLP [=good laboratory practice] repeated dose toxicity study in rats with 5 weekly doses of Kevetrin, in the range of 60 to 120 mg/kg given intravenously showed a NOAEL [=no observed adverse effect level] of Kevetrin of 90 mg/kg.
A GLP repeated dose toxicity study in dogs with 5 weekly doses of Kevetrin, in the range of 5 to 60 mg/kg given intravenously showed a NOAEL of 5 mg/kg.
According to this, no adverse effects were observable in rats at a dose of 90mg/kg and in dogs at 5 mg/kg. Here is where CTIX owners would want people to be more like rats than dogs because 90 mg/kg in rats translates to a BSA based dose of 540mg/m2, almost the same as the reported dose with positive data in mouse model studies, but 5 mg/kg in dogs translates to 100 mg/m2 which is a sixth of that. I am afraid that though behaviorally we often approach the rat measures, physiologically the dog is closer. Even so, these are NOAEL, meaning, no observed adverse effect level. There is room to go higher where some adverse effects may be seen. The full Phase I data from the study under way at Dana-Farber needs to be awaited on this, but if I had to bet (which is what a buyer is doing now) based on what has been reported, the odds are in Kevetrin's favor to show benefit at tolerated doses.
As has been written by many before, there are many good reasons to be excited about this company and its products, both from the perspective of cures and from that of investment. If Kevetrin is successful, I think it will only be the first step in a development process that one may compare to penicillin going to ampicillin and amoxicillin, where the company's patents might afford wide protection from competition. However, caution is in order for that first step. This is a new molecule. The pharmacokinetic and safety data in humans is only beginning to be collected.
In a way, to speculate on this kind of stuff ahead of actual data may seem rash, and if you feel that way, you are really reading the wrong kind of articles related to stocks. You want established companies with a record of revenue and profit, even growth. This one ain't there yet. One is not sure if it will get there. If and when it gets there one should be able to buy it at 10 times today's share price, but with the mind more at ease about one's investment...."
http://seekingalpha.com/article/1567392-cellc...of-success
Good luck and GOD bless,
George
CTIX Latest DD (Updated)
"* Kevetrin Phase 1--Cohort 8 in progress @ 215mg/m2--No MTD yet established--http://cellceutix.com/cellceutix-clinical-trial-of-anti-cancer-drug-kevetrin-entering-eighth-cohort/#sthash.6pctRV6R.dpbs
* K in combination against renal completed most if not all preclinical work.
* K in combination against leukemia (AML) already [completed] preclinical work at UofB and a Phase 1b/2 Clinical Trial is poised to start once MTD is established in K/P1
* K against Retinoblastoma announced in March 2013 will commence after MTD is established in P1
* Prurisol bridge study complete--Awaiting final report before submission to FDA for P2 trial--Anticipated start date 1Q/15--http://cellceutix.com/cellceutix-anti-psoriasis-drug-prurisol-meets-primary-endpoint-of-clinical-trial/#sthash.fYZzgvRO.dpbs
* B against ABSSSI near 100% enrollment and treated NO AE's--Expected completion within a couple of weeks
* B OM Preparing to submit to FDA for approval of P2 trial--http://cellceutix.com/cellceutix-prepares-for-phase-2-clinical-trial-of-brilacidin-om-for-oral-mucositis/#sthash.SpoCUTpB.dpbs--
* B ocular formulation studies underway at Dr Reddy's and should complete within the next few to 6 months.
* B otic also in formulation studies at Dr Reddy's
* B DFI just announced high efficacy and should begin final preclinical work ahead of clinical testing. "
*B NY/ NJ universities material transfer agreement defensive mimetics
*Cellceutix in June, 2014, entered into a research agreement with a renowned non-profit research institution for studies of anti-fungal compounds in Cellceutix’s portfolio. The research is to be funded by a $1.5 million grant from the National Institute of Health, Small Business Innovation Research (SBIR) to the non-profit institution.
I figure this is a good time to rehash this as there are new eyes abound lately.
Thanks to Alex for putting most of this together.
Thanks for the list Farrell! My favorite is #6, especially this statement:
*Stabilization was achieved at low doses in terminal patients with relapsed tumors that were resistant to current chemotherapies
Since the trial was in the 5th cohort at that time, the "low doses" had to be 75 mg/m2 or less. Now cohort 8 is almost 3x the dosage. This is the reason why I am really looking forward to this year's R&R. Only three more weeks.
vip,
that also makes this interesting to watch play out. Will it form a handle or just breakout. Timing of news could play a big part in that. The size of friday's move and closing a fair distance above the upper bb could favor the forming of a handle. Especially, since historically CTIX gets back inside the bb's very quickly.
Would be a nice spot for a bull flag too.
Thanks for the discussion vip and ee. Have a great finish to your weekend and Trade Green.
Cup and handle, waiting for the cup to form completely at 1.90 then a short handle and the way we go.
http://stockcharts.com/school/doku.php?st=cup...ntinuation
Quote:
BigKahuna Friday, 10/05/12 06:53:29 PM
Re: None
Read then think!!!
"...Prior data is in favor of Kevetrin showing enough safety so that I think the Phase I trial, when completed, will advance the compound and the stock. Here I have taken a careful look at the numbers published previously. With Kevetrin, the situation is the opposite of Prurisol. There is a greater reason to be confident about effectiveness. The unknown is toxicity. One of the facts that stands out when one peruses the reported Phase I data is that the first cohort was started at a very low dose compared to that in the reported pre-clinical studies. The beginning low dose makes sense when this is the first use in a live human of a new compound. However, we wonder if and when it will get to concentrations enough to produce therapeutic benefit. As has been pointed out on forums elsewhere, the beginning dose for the Dana-Farber trial was only a 60th of the dose used to generate the positive pre-clinical data (200mg/kg in mice) reported. Also, the pre-clinical studies employed intraperitoneal administration and the Phase I study uses iv infusion. The two modes of administration are likely to be associated with different effects in regard to drug behavior and distribution, as well as toxicity.
Dosage is considered better correlated to body surface area, and that is how the Phase I dosage has been reported. The first round was 10mg/m2. The relationship between mg/kg and BSA in various animals and people has been worked out (FASEB J. 22, 659-661 [2007]) and 200mg/kg in mice corresponds to 600 mg/m2 in humans. Here are two big questions to which we should find the answer when the Phase I trial is complete and results are reported: can patients tolerate a dose of 600mg/m2, and is that high a dose necessary for effectiveness? Will Kevetrin have anti-cancer effect at doses at which adverse effects are tolerable for the majority of patients? Here I find the following reported toxicity to dogs and rats to be encouraging.
A GLP [=good laboratory practice] repeated dose toxicity study in rats with 5 weekly doses of Kevetrin, in the range of 60 to 120 mg/kg given intravenously showed a NOAEL [=no observed adverse effect level] of Kevetrin of 90 mg/kg.
A GLP repeated dose toxicity study in dogs with 5 weekly doses of Kevetrin, in the range of 5 to 60 mg/kg given intravenously showed a NOAEL of 5 mg/kg.
According to this, no adverse effects were observable in rats at a dose of 90mg/kg and in dogs at 5 mg/kg. Here is where CTIX owners would want people to be more like rats than dogs because 90 mg/kg in rats translates to a BSA based dose of 540mg/m2, almost the same as the reported dose with positive data in mouse model studies, but 5 mg/kg in dogs translates to 100 mg/m2 which is a sixth of that. I am afraid that though behaviorally we often approach the rat measures, physiologically the dog is closer. Even so, these are NOAEL, meaning, no observed adverse effect level. There is room to go higher where some adverse effects may be seen. The full Phase I data from the study under way at Dana-Farber needs to be awaited on this, but if I had to bet (which is what a buyer is doing now) based on what has been reported, the odds are in Kevetrin's favor to show benefit at tolerated doses.
As has been written by many before, there are many good reasons to be excited about this company and its products, both from the perspective of cures and from that of investment. If Kevetrin is successful, I think it will only be the first step in a development process that one may compare to penicillin going to ampicillin and amoxicillin, where the company's patents might afford wide protection from competition. However, caution is in order for that first step. This is a new molecule. The pharmacokinetic and safety data in humans is only beginning to be collected.
In a way, to speculate on this kind of stuff ahead of actual data may seem rash, and if you feel that way, you are really reading the wrong kind of articles related to stocks. You want established companies with a record of revenue and profit, even growth. This one ain't there yet. One is not sure if it will get there. If and when it gets there one should be able to buy it at 10 times today's share price, but with the mind more at ease about one's investment...."
http://seekingalpha.com/article/1567392-cellc...of-success
Good luck and GOD bless,
George
CTIX Latest DD (Updated)
"* Kevetrin Phase 1--Cohort 8 in progress @ 215mg/m2--No MTD yet established--http://cellceutix.com/cellceutix-clinical-trial-of-anti-cancer-drug-kevetrin-entering-eighth-cohort/#sthash.6pctRV6R.dpbs
* K in combination against renal completed most if not all preclinical work.
* K in combination against leukemia (AML) already [completed] preclinical work at UofB and a Phase 1b/2 Clinical Trial is poised to start once MTD is established in K/P1
* K against Retinoblastoma announced in March 2013 will commence after MTD is established in P1
* Prurisol bridge study complete--Awaiting final report before submission to FDA for P2 trial--Anticipated start date 1Q/15--http://cellceutix.com/cellceutix-anti-psoriasis-drug-prurisol-meets-primary-endpoint-of-clinical-trial/#sthash.fYZzgvRO.dpbs
* B against ABSSSI near 100% enrollment and treated NO AE's--Expected completion within a couple of weeks
* B OM Preparing to submit to FDA for approval of P2 trial--http://cellceutix.com/cellceutix-prepares-for-phase-2-clinical-trial-of-brilacidin-om-for-oral-mucositis/#sthash.SpoCUTpB.dpbs--
* B ocular formulation studies underway at Dr Reddy's and should complete within the next few to 6 months.
* B otic also in formulation studies at Dr Reddy's
* B DFI just announced high efficacy and should begin final preclinical work ahead of clinical testing. "
*B NY/ NJ universities material transfer agreement defensive mimetics
*Cellceutix in June, 2014, entered into a research agreement with a renowned non-profit research institution for studies of anti-fungal compounds in Cellceutix’s portfolio. The research is to be funded by a $1.5 million grant from the National Institute of Health, Small Business Innovation Research (SBIR) to the non-profit institution.
I figure this is a good time to rehash this as there are new eyes abound lately.
Thanks to Alex for putting most of this together.
Thanks for the list Farrell! My favorite is #6, especially this statement:
*Stabilization was achieved at low doses in terminal patients with relapsed tumors that were resistant to current chemotherapies
Since the trial was in the 5th cohort at that time, the "low doses" had to be 75 mg/m2 or less. Now cohort 8 is almost 3x the dosage. This is the reason why I am really looking forward to this year's R&R. Only three more weeks.
vip,
that also makes this interesting to watch play out. Will it form a handle or just breakout. Timing of news could play a big part in that. The size of friday's move and closing a fair distance above the upper bb could favor the forming of a handle. Especially, since historically CTIX gets back inside the bb's very quickly.
Would be a nice spot for a bull flag too.
Thanks for the discussion vip and ee. Have a great finish to your weekend and Trade Green.
Cup and handle, waiting for the cup to form completely at 1.90 then a short handle and the way we go.
http://stockcharts.com/school/doku.php?st=cup...ntinuation
Quote:
BigKahuna Friday, 10/05/12 06:53:29 PM
Re: None
