August 16, 2015
Dear Dr. KSS,
Unfortunately, the day we spoke was the Thursday the Seeking Alpha article written by an anonymous author was released. With all that was going on, I still honored my appointment for the call with you and others. Perhaps you didn’t know I was at my computer and reading emails from shareholders and others, some shareholders who I have known for years, asking whether the article had any truth to it. Of course there was nothing true to it. Therefore, in retrospect my answers to the group may not have been as clear as I would have hoped them to be due to the events happening real time.
I would like to address some of the points in your article. Perhaps they may (slightly to significantly) change your conclusion.
I agree that Prurisol, from a business perspective, is our riskiest project. The trial only just began and I have no data (yet). The reason we pursued it to the clinic is because the animal data was so compelling. A full response! At this point we are now in the clinical trial and we will all know soon enough.
I actually create wealth for shareholders. I addressed these issues in our press release to shareholders.
I would like to point out that investors during my time at NNVC did very well. I can’t be held responsible as to the actions and to the price of the company after I left.
At CTIX we are working hard to enrich shareholders. I haven’t sold a single share and the company owes me millions of dollars of check deposits I put into the company. That’s the confidence I have in our compounds. Until the other week’s event our shareholders had done very well. I believe we haven’t even scratched the surface of our potential value.
“avowed anticancer agent Kevetrin, as yet with no proven clinical activity, was mired in an ongoing, ceaseless phase 1 trial, with doses being escalated far beyond a clinically appropriate dose in quest for a vaunted “maximum tolerated dose.” [-'Dr' KSS]
Your statement is totally incorrect and is the most important reason why you are drawing the wrong conclusion about Cellceutix.
All patients in all cohorts have their blood drawn and sent for “PK” analysis. The clinical investigator’s and our teams see the results and the Safety Review Committee decides whether to increase dosing is made based on this and safety data. If the “PK” data indicates the higher dose is more effective, of course we will increase dosing. Our recent statements that we expect to conclude the trial soon means the rate of increased benefit to increased dosing is getting narrower. It has zero to do with lets give the patient more drug.
About the clinical benefits of Kevetrin, we have released ASCO posters and certain other information through press releases that should reassure one of the enormous potential of the drug. Our last press release mentioned a patient in our trial now in his 11th month on Kevetrin and had stable disease. The important read is the time, 11 months. I want to direct you to
http://seekingalpha.com/news/2593255-epizymes...33-percent
Epizyme's tazemetostat demonstrates 60% response rate in advanced lymphoma; shares jump 33%
Some points to note:
Epizyme stock went way over a billion dollar market cap.
The article states:
"The patient with the EZH2 mutation, who was refractory or had relapsed to six previous treatment regimens, achieved a partial response after 16 weeks of therapy and remains on study."
"One patient remains on study at 18 months of treatment. Three of five (60%) evaluable patients with follicular lymphoma achieved an objective response. One patient with a complete response remains on study at 13 months as is one patient with a partial response."
Well all our patients are refractory tumors. Our trial is a much more difficult trial. We are dealing with all very late stage solid tumors (and different) which in most patients has metastasized to other organs. In a blood cancer you are injecting the drug directly into the tumors, unlike our trial. Once we select cancers for Phase 2 studies, dosing methods and strategies likely change.
I wish our patient mentioned above many many more years of life and I hope Kevetrin helps him to achieve this.
A few other important points:
We do not hire promoters!
Regarding “ENROLLING BY INVITATION ONLY,” we used the same clinical sites that all the other approved ABSSSI drugs used. Why they request this language, I do not know. Perhaps it’s because patients are from the Hospitals emergency room and are not recruited elsewhere. I can look into this.
You are completely misinformed about the physicians we recruited for our board of directors. It is the exact opposite of what you state. I wanted physicians with lots and lots of clinical trial experience who also have practices. These physicians understand the drug reimbursement policies of insurance companies. They both run clinical trials for big pharma. Many trials. They are key opinion leaders and consult for Novartis and others. They bring enormous value to our shareholders.
Last week the reporter from Boston Business and some shareholders visited our offices and the labs directly behind our offices. Our premises were formerly occupied by Cell Signaling. Very high quality labs that we even upgraded. I assure you that the labs, significantly larger than the office space is used and significant research is going on there.
Well, please visit us in Beverly and see for yourself.
At CTIX we don't sleep on our accomplishments to date. We are always planning for additional trials and growth of CTIX. I notice that you are a gastroenterologist. I want to share with you some of Drs Alexander and Menon’s notes sent to me from this years meeting in Orlando with key GI opinion leaders. (Attached) I would like to present you with a question. If you were in my shoes what would you do? There is grant money which is being used to study our gram negative compounds. We can try to speed up development by spending an enormous sum of money and then need to do a tox, phase 1, and efficacy in humans will only be known in Phase 2. Or wait until definitive data comes in from the oral mucositis trial and then we are close to certainty the drug will be effective for ulcerative proctitis, ulcerative colitis, crohns and IBD. Of course for crohns and IBD we will need to develop an oral formulation. I will go by your expertise but I have been told by other GI physicians the market for these diseases will certainly generate much greater revenues to CTIX with much less risk.
I hope you will be open minded and take the time to reassess your opinion of Cellceutix with what I have shared with you. You are welcome to visit us in our labs and there you will learn a lot more about Cellceutix which will amaze you!
Leo Ehrlich
Dear Dr. KSS,
Unfortunately, the day we spoke was the Thursday the Seeking Alpha article written by an anonymous author was released. With all that was going on, I still honored my appointment for the call with you and others. Perhaps you didn’t know I was at my computer and reading emails from shareholders and others, some shareholders who I have known for years, asking whether the article had any truth to it. Of course there was nothing true to it. Therefore, in retrospect my answers to the group may not have been as clear as I would have hoped them to be due to the events happening real time.
I would like to address some of the points in your article. Perhaps they may (slightly to significantly) change your conclusion.
I agree that Prurisol, from a business perspective, is our riskiest project. The trial only just began and I have no data (yet). The reason we pursued it to the clinic is because the animal data was so compelling. A full response! At this point we are now in the clinical trial and we will all know soon enough.
I actually create wealth for shareholders. I addressed these issues in our press release to shareholders.
I would like to point out that investors during my time at NNVC did very well. I can’t be held responsible as to the actions and to the price of the company after I left.
At CTIX we are working hard to enrich shareholders. I haven’t sold a single share and the company owes me millions of dollars of check deposits I put into the company. That’s the confidence I have in our compounds. Until the other week’s event our shareholders had done very well. I believe we haven’t even scratched the surface of our potential value.
“avowed anticancer agent Kevetrin, as yet with no proven clinical activity, was mired in an ongoing, ceaseless phase 1 trial, with doses being escalated far beyond a clinically appropriate dose in quest for a vaunted “maximum tolerated dose.” [-'Dr' KSS]
Your statement is totally incorrect and is the most important reason why you are drawing the wrong conclusion about Cellceutix.
All patients in all cohorts have their blood drawn and sent for “PK” analysis. The clinical investigator’s and our teams see the results and the Safety Review Committee decides whether to increase dosing is made based on this and safety data. If the “PK” data indicates the higher dose is more effective, of course we will increase dosing. Our recent statements that we expect to conclude the trial soon means the rate of increased benefit to increased dosing is getting narrower. It has zero to do with lets give the patient more drug.
About the clinical benefits of Kevetrin, we have released ASCO posters and certain other information through press releases that should reassure one of the enormous potential of the drug. Our last press release mentioned a patient in our trial now in his 11th month on Kevetrin and had stable disease. The important read is the time, 11 months. I want to direct you to
http://seekingalpha.com/news/2593255-epizymes...33-percent
Epizyme's tazemetostat demonstrates 60% response rate in advanced lymphoma; shares jump 33%
Some points to note:
Epizyme stock went way over a billion dollar market cap.
The article states:
"The patient with the EZH2 mutation, who was refractory or had relapsed to six previous treatment regimens, achieved a partial response after 16 weeks of therapy and remains on study."
"One patient remains on study at 18 months of treatment. Three of five (60%) evaluable patients with follicular lymphoma achieved an objective response. One patient with a complete response remains on study at 13 months as is one patient with a partial response."
Well all our patients are refractory tumors. Our trial is a much more difficult trial. We are dealing with all very late stage solid tumors (and different) which in most patients has metastasized to other organs. In a blood cancer you are injecting the drug directly into the tumors, unlike our trial. Once we select cancers for Phase 2 studies, dosing methods and strategies likely change.
I wish our patient mentioned above many many more years of life and I hope Kevetrin helps him to achieve this.
A few other important points:
We do not hire promoters!
Regarding “ENROLLING BY INVITATION ONLY,” we used the same clinical sites that all the other approved ABSSSI drugs used. Why they request this language, I do not know. Perhaps it’s because patients are from the Hospitals emergency room and are not recruited elsewhere. I can look into this.
You are completely misinformed about the physicians we recruited for our board of directors. It is the exact opposite of what you state. I wanted physicians with lots and lots of clinical trial experience who also have practices. These physicians understand the drug reimbursement policies of insurance companies. They both run clinical trials for big pharma. Many trials. They are key opinion leaders and consult for Novartis and others. They bring enormous value to our shareholders.
Last week the reporter from Boston Business and some shareholders visited our offices and the labs directly behind our offices. Our premises were formerly occupied by Cell Signaling. Very high quality labs that we even upgraded. I assure you that the labs, significantly larger than the office space is used and significant research is going on there.
Well, please visit us in Beverly and see for yourself.
At CTIX we don't sleep on our accomplishments to date. We are always planning for additional trials and growth of CTIX. I notice that you are a gastroenterologist. I want to share with you some of Drs Alexander and Menon’s notes sent to me from this years meeting in Orlando with key GI opinion leaders. (Attached) I would like to present you with a question. If you were in my shoes what would you do? There is grant money which is being used to study our gram negative compounds. We can try to speed up development by spending an enormous sum of money and then need to do a tox, phase 1, and efficacy in humans will only be known in Phase 2. Or wait until definitive data comes in from the oral mucositis trial and then we are close to certainty the drug will be effective for ulcerative proctitis, ulcerative colitis, crohns and IBD. Of course for crohns and IBD we will need to develop an oral formulation. I will go by your expertise but I have been told by other GI physicians the market for these diseases will certainly generate much greater revenues to CTIX with much less risk.
I hope you will be open minded and take the time to reassess your opinion of Cellceutix with what I have shared with you. You are welcome to visit us in our labs and there you will learn a lot more about Cellceutix which will amaze you!
Leo Ehrlich
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