My thoughts on R&R and the current state of affairs for CTIX, I am as optimistic as ever and very excited for what the remainder of 2013 will bring.
I think the toughest thing for many of us is simply the wait. With so many of us closely following every development and dissecting every PR or email tidbit, it can sometimes feel like things are taking forever to develop. This is what happens when a company with incredible potential like we have here experiences delays/slow downs and a trial with very challenging advanced stage disease patients.
And of course, the P21 anticipation and gaps in communication/execution on that end also can raise anxiety and impatience. However, this is just the nature of biotech sometimes. We have an outstanding CEO who communicates honestly with shareholders and does his best to be transparent and forward in his communication.
With that said, we must remember that beyond the excellent work that Leo does from a business standpoint to set up, finance, and coordinate all of these trials and studies, his hands are very much tied in terms of information flow and operational pacing of the trials.
This is to be expected when you outsource all of your most important work to several of the most prestigious cancer research centers on the planet. I am positive Leo is at times as frustrated with pacing and limitations on communication as we are. But in due time we will all be immensely rewarded for our patience and conviction.
When the science is proven, it will have incredible implications for shareholders financially. But more importantly, it will fundamentally change the tone of those tough conversations happening between patients and oncologists. I look forward, with immense optimism and joy, to the day that kevetrin is the life changer that we all believe it will be.
As for the Kevetrin trial itself, we are right at this moment at an inflection point. A very exciting but also very challenging time. Exciting in the sense that dosing levels are presumably approaching a significant level that many of us are hoping will start to show significant effectiveness. (Which hopefully will be confirmed tomorrow!!!)
But this also makes it a challenging time from a shareholder standpoint. I think many of us feel like the excellent progress made to date hasn't been served justice due to the constraints on communicating what has happened so far and the delayed P21 results. But once again, our patience here well be immensely rewarded in due time. Hopefully we get a good dose of positive news coming out of R&R to hold us over for a while.
As for my thoughts on the potential from the different dosing levels of the K trial, to me it breaks down roughly along these lines (and I emphasize "roughly"):
0 - 100 mg/m2:
Minimal, but still quantifiable P21 increased expression/P53 activation. Certainly not enough to slow aggressive and fast spreading stage 4 cancer, but this low dosage range is very significant in a sense that it establishes two important elements:
1. Initial safety profile. Just confirming there are no crazy/unexpected complications from putting a novel chemical agent into humans is a big step forward. Confirming there is no outright rejection by the liver and other organs is in itself a very important step, even though it is obviously a very, very long way from an effective MTD.
2. Even just a simple confirmation at a molecular level of minimal increased P21 expression is a huge win. This allows us to say at a very, very basic level that "it works". Again here we are a long way away from MTD and efficacy against aggressive disease, but being able to say "it works" is a big deal, as it then raises the more important question of "how well does it work?".
100-200 mg/m2:
First noticeable signs of tumor growth delay as confirmed through secondary endpoint measures. We may see minimal slowing of how fast cancer is growing. Also, in my opinion an announcement tomorrow that we are at 200mg/m2 in cohort 6 would to me mean that the dana farber trial can already be called a success from a primary endpoint safety profile perspective.
Even if we somehow went no further beyond 200mg/m2, i believe this is the magic number that starts to make kevetrin extremely valuable. Because even if the stand alone efficacy results themselves are not all that potent, this dosing level (200mg/m2) IMO widely opens the door for the expansion and pursuit of much stronger efficacy results through combination trials. The University of Bologna trial comes to mind here, as I believe we will see some very impressive results from this trial. Also, I am very anxious to see what Kevetrin could do in combination with radiation, as the preclinicals were very impressive, with Kevetrin sensitizing cancer cells to radiation, effectively "supercharging" the effectiveness of radiation alone, when given AFTER dosing of Kevetrin.
200-400 mg/m2:
Now this is where the rubber really hits the road IMO. P21/P53 activation is dramatically increased, and I believe we would firmly be reaching a point of slowing and possibly even stopping disease in its tracks. Remember these three letters, they will be important to us in the near future : PFS. Progression Free Survival. I believe the higher end of this dosing range can also start to show quantifiable PFS, showing clear and potent efficacy against aggressive and difficult to treat cancers.
450 mg/m2 and beyond:
Simply put, this is where the fireworks go off. To me it is very straight forward. If the Dana Farber trial can go to 8 cohorts, or possibly 9 to hit MTD, the results in humans will be as impressive and wide ranging as they were in preclinicals. Here Kevetrin would start to mop the floor and kick cancer's ass across several types and stages of disease. (To put it eloquently.) Making it this far solidifies Kevetrin as THE foundation and backbone for the next generation of cancer treatments.
Just some Sunday morning rambling/thoughts, would love to hear everyone's opinion on my opinion. some may think I am far too optimistic, but I firmly believe we are 2-3 cohorts away from some incredible results. And i will say we all have obviously very high expectations for K here, but if we truly are at 200mg/m2, the big implications of a good safety profile at this level cannot be overstated. I think we are on the verge of having safety success at Dana Farber, a very exciting and reassuring achievement in itself - I hope we all dont lose sight of that!
I look forward to the conference, I moved out work meetings so i could stream live from the office, LOL. The best is yet to come, and I think we get a taste of what that means from Leo tomorrow. ATL! Hope everyone has had a good weekend, and I hope we all have a better week coming up ahead.
(Side note : i HATE how this site never lets you copy/paste from another site without losing all your proper spacing and lumping it all into one huge paragraph!) ugh
I think the toughest thing for many of us is simply the wait. With so many of us closely following every development and dissecting every PR or email tidbit, it can sometimes feel like things are taking forever to develop. This is what happens when a company with incredible potential like we have here experiences delays/slow downs and a trial with very challenging advanced stage disease patients.
And of course, the P21 anticipation and gaps in communication/execution on that end also can raise anxiety and impatience. However, this is just the nature of biotech sometimes. We have an outstanding CEO who communicates honestly with shareholders and does his best to be transparent and forward in his communication.
With that said, we must remember that beyond the excellent work that Leo does from a business standpoint to set up, finance, and coordinate all of these trials and studies, his hands are very much tied in terms of information flow and operational pacing of the trials.
This is to be expected when you outsource all of your most important work to several of the most prestigious cancer research centers on the planet. I am positive Leo is at times as frustrated with pacing and limitations on communication as we are. But in due time we will all be immensely rewarded for our patience and conviction.
When the science is proven, it will have incredible implications for shareholders financially. But more importantly, it will fundamentally change the tone of those tough conversations happening between patients and oncologists. I look forward, with immense optimism and joy, to the day that kevetrin is the life changer that we all believe it will be.
As for the Kevetrin trial itself, we are right at this moment at an inflection point. A very exciting but also very challenging time. Exciting in the sense that dosing levels are presumably approaching a significant level that many of us are hoping will start to show significant effectiveness. (Which hopefully will be confirmed tomorrow!!!)
But this also makes it a challenging time from a shareholder standpoint. I think many of us feel like the excellent progress made to date hasn't been served justice due to the constraints on communicating what has happened so far and the delayed P21 results. But once again, our patience here well be immensely rewarded in due time. Hopefully we get a good dose of positive news coming out of R&R to hold us over for a while.
As for my thoughts on the potential from the different dosing levels of the K trial, to me it breaks down roughly along these lines (and I emphasize "roughly"):
0 - 100 mg/m2:
Minimal, but still quantifiable P21 increased expression/P53 activation. Certainly not enough to slow aggressive and fast spreading stage 4 cancer, but this low dosage range is very significant in a sense that it establishes two important elements:
1. Initial safety profile. Just confirming there are no crazy/unexpected complications from putting a novel chemical agent into humans is a big step forward. Confirming there is no outright rejection by the liver and other organs is in itself a very important step, even though it is obviously a very, very long way from an effective MTD.
2. Even just a simple confirmation at a molecular level of minimal increased P21 expression is a huge win. This allows us to say at a very, very basic level that "it works". Again here we are a long way away from MTD and efficacy against aggressive disease, but being able to say "it works" is a big deal, as it then raises the more important question of "how well does it work?".
100-200 mg/m2:
First noticeable signs of tumor growth delay as confirmed through secondary endpoint measures. We may see minimal slowing of how fast cancer is growing. Also, in my opinion an announcement tomorrow that we are at 200mg/m2 in cohort 6 would to me mean that the dana farber trial can already be called a success from a primary endpoint safety profile perspective.
Even if we somehow went no further beyond 200mg/m2, i believe this is the magic number that starts to make kevetrin extremely valuable. Because even if the stand alone efficacy results themselves are not all that potent, this dosing level (200mg/m2) IMO widely opens the door for the expansion and pursuit of much stronger efficacy results through combination trials. The University of Bologna trial comes to mind here, as I believe we will see some very impressive results from this trial. Also, I am very anxious to see what Kevetrin could do in combination with radiation, as the preclinicals were very impressive, with Kevetrin sensitizing cancer cells to radiation, effectively "supercharging" the effectiveness of radiation alone, when given AFTER dosing of Kevetrin.
200-400 mg/m2:
Now this is where the rubber really hits the road IMO. P21/P53 activation is dramatically increased, and I believe we would firmly be reaching a point of slowing and possibly even stopping disease in its tracks. Remember these three letters, they will be important to us in the near future : PFS. Progression Free Survival. I believe the higher end of this dosing range can also start to show quantifiable PFS, showing clear and potent efficacy against aggressive and difficult to treat cancers.
450 mg/m2 and beyond:
Simply put, this is where the fireworks go off. To me it is very straight forward. If the Dana Farber trial can go to 8 cohorts, or possibly 9 to hit MTD, the results in humans will be as impressive and wide ranging as they were in preclinicals. Here Kevetrin would start to mop the floor and kick cancer's ass across several types and stages of disease. (To put it eloquently.) Making it this far solidifies Kevetrin as THE foundation and backbone for the next generation of cancer treatments.
Just some Sunday morning rambling/thoughts, would love to hear everyone's opinion on my opinion. some may think I am far too optimistic, but I firmly believe we are 2-3 cohorts away from some incredible results. And i will say we all have obviously very high expectations for K here, but if we truly are at 200mg/m2, the big implications of a good safety profile at this level cannot be overstated. I think we are on the verge of having safety success at Dana Farber, a very exciting and reassuring achievement in itself - I hope we all dont lose sight of that!
I look forward to the conference, I moved out work meetings so i could stream live from the office, LOL. The best is yet to come, and I think we get a taste of what that means from Leo tomorrow. ATL! Hope everyone has had a good weekend, and I hope we all have a better week coming up ahead.
(Side note : i HATE how this site never lets you copy/paste from another site without losing all your proper spacing and lumping it all into one huge paragraph!) ugh
