Dr. B answer about K - I posted this on iHub and r
Post# of 72440
Posted On: 08/03/2016 8:28:32 AM
Dr. B answer about K - I posted this on iHub and really believe in this answer.
A: Kevetrin TM for ovarian cancer is a very high priority for us. Everything that I have seen on Kevetrin TM and its effect on p53 has me hopeful that we could have a blockbuster in hand. What we're doing right at this moment is making some modifications to the Phase 2 trial design in a manner that I believe will shorten the duration of the study. Our short-term goal of the planned ovarian cancer trial is aimed at unequivocally demonstrating modulation of p53 directly in tumor tissue, as well as associated clinical response measured by RECIST. Further, we believe that it will be an anchor if we can demonstrate that the response in rodents is mirrored in treatment of patients.
To accomplish this, we are doing studies in the lab in animal models of ovarian cancer aimed at demonstrating the effect of Kevetrin TM activation of p53 to treat the disease. This strategy should enable us to further anchor the effect of Kevetrin TM in the Phase 2 trial as it relates to key biologic measures. In my opinion, many companies make a mistake by prematurely jumping to a long-term endpoint such as progression-free survival, before proof of concept is firmly established. It is a compelling story to tell if you can see the effect of a compound in an animal model replicated in human studies. Kevetrin TM with a confirmed novel mechanism of action should get potential partners very excited. Our goal is to do a very rewarding deal with a major partner and for that to happen, we need to give them superb data.
I'll add that we are also actively working on different formulations of Kevetrin TM, including an oral formulation and different delivery methods. The Cellceutix team was already working on this area and I am completely on-board with filling a void in oncology to give patients better options for receiving their therapy. It goes without saying that a new, effective drug with a better delivery method has significant potential."
A: Kevetrin TM for ovarian cancer is a very high priority for us. Everything that I have seen on Kevetrin TM and its effect on p53 has me hopeful that we could have a blockbuster in hand. What we're doing right at this moment is making some modifications to the Phase 2 trial design in a manner that I believe will shorten the duration of the study. Our short-term goal of the planned ovarian cancer trial is aimed at unequivocally demonstrating modulation of p53 directly in tumor tissue, as well as associated clinical response measured by RECIST. Further, we believe that it will be an anchor if we can demonstrate that the response in rodents is mirrored in treatment of patients.
To accomplish this, we are doing studies in the lab in animal models of ovarian cancer aimed at demonstrating the effect of Kevetrin TM activation of p53 to treat the disease. This strategy should enable us to further anchor the effect of Kevetrin TM in the Phase 2 trial as it relates to key biologic measures. In my opinion, many companies make a mistake by prematurely jumping to a long-term endpoint such as progression-free survival, before proof of concept is firmly established. It is a compelling story to tell if you can see the effect of a compound in an animal model replicated in human studies. Kevetrin TM with a confirmed novel mechanism of action should get potential partners very excited. Our goal is to do a very rewarding deal with a major partner and for that to happen, we need to give them superb data.
I'll add that we are also actively working on different formulations of Kevetrin TM, including an oral formulation and different delivery methods. The Cellceutix team was already working on this area and I am completely on-board with filling a void in oncology to give patients better options for receiving their therapy. It goes without saying that a new, effective drug with a better delivery method has significant potential."
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