Leo’s Comments on Prurisol
TLSR: We have not talked much about Prurisol. Would you give a little background on that compound?
LE: Prurisol is a prodrug of a marketed drug called abacavir sulfate (Ziagen; GlaxoSmithKline [GSK:NYSE]), a nucleoside analog that has been phenomenal for treating HIV. It's a reverse transcriptase inhibitor, and was originally approved in the U.S. back in 1998. We have made changes to the molecule, but because of its similarity and long use in humans, it is eligible for the FDA's 505(b)(2) drug approval pathway, which is an abbreviated pathway for a drug already in use. This drug is actually the longest shot we have because the Phase 2 trial is the first treating psoriatic patients, and we will begin getting human data around the end of April. It's a double-blind study, so we don't know anything at this point. The path forward is quite logical, though. If the drug performs like abacavir, one might be inclined to think that there won't be activity against psoriasis. However, based on preclinical animal studies, for which we have published images of mouse models, we do expect Prurisol activity in this study. So the path is: Study the data including safety, determine which dose of the three did best, see time points when improvements occurred, and if warranted, proceed to further advanced clinical studies (i.e. Phase 2b/3 or Phase 3).
http://www.thelifesciencesreport.com/pub/na/a...-jorgensen
“Given that psoriasis is a chronic condition with limited effective therapies that the National Psoriasis Foundation lists as affecting 125 million people worldwide, we see a tremendous market opportunity for an effective new oral treatment. As previously reported, enrollment in the Phase 2 trial was completed in November and we are expecting top-line data in April/May 2016.”
http://cellceutix.com/best-yet-to-come/#sthash.b1XlMghR.dpuf
“The goal is to show the compound is safe and effective, while pointing us to an optimal dosing regimen for a late-stage trial. For the good of the millions of people suffering from psoriasis, we hope that Prurisol can one day provide a much-needed option to often-used biologics that are known to have side effects and contraindications, while eventually losing effectiveness in many patients.”
http://cellceutix.com/cellceutix-phase-2-tria...Ped57.dpuf
You have frequently spoken of Kevetrin as being unique and novel due to its revolutionary mechanism of action that activates the P53 gene. What unique or compelling advantage does Prurisol offer over existing treatments or competing anti-psoriasis compounds that are also currently in clinical trials?
It is too early for us to compare Prurisol to other competing compounds in clinical trials. We do know the toxicity profile of Prurisol, but we don't know the profiles of the other drugs as they are not yet publicly available. What most impressed us about Prurisol in the animal studies was not simply that the psoriasis was visually eliminated, but that the psoriasis did not recur. There are many fine drugs out there to rid psoriatic lesions, but the results are temporary. Thereafter the individual will build resistance to the drug and it will become ineffective. Additionally, the problem with the biologic drugs is the potential for serious side effects. A new drug is urgently needed to help those suffering from psoriasis, which is a very uncomfortable and sometimes debilitating disease affecting millions of people in the U.S. alone.
Dr. Krishna Menon, the intellectual powerhouse behind the development of the compound, is widely respected for his keen ability to identify successful compounds in a crowded sea of possibilities. What compelled Dr. Menon to put his energy and innovative approach into Prurisol?
The idea for a psoriasis drug actually came from others and we licensed their compound. However it wasn't achieving the results we had hoped for. Cellceutix thereafter developed Prurisol. Once the patent is published, people will have a better understanding of our thought process in the development of Prurisol and how we accomplished making this new compound. At this time, we are keeping our intellectual property close to the vest until it is properly protected.
What gives you confidence that the dramatic results shown so far in your lab studies will be achieved in human testing?
Of course, things can be different in humans as compared to animal research, but by utilizing mice with compromised immune systems and human xenograph models, we replicated the conditions as closely as possible in the laboratory studies. This is a recognized methodology in animal models for preclinical testing. Also, Dr. Menon's decades' of experience and understanding of the chemistry of the drug and his knowledge of the pathology of the lab studies lends a great deal of validation and confidence heading into human trials.
Dr Reddy's Labs was your choice to synthesize and manufacture Prurisol in preparation for the upcoming clinical trial. What was the logic behind selecting Dr Reddy's for this process?
Dr Reddy's is the second largest drug producer in India. They are a New York Stock Exchange listed company with a market cap of over five billion dollars ($5,000,000,000). They are among the world's largest manufacturers of the starting active pharmaceutical ingredient in Prurisol. Therefore, their familiarity in producing a product such as Prurisol is second to none.
How close is Dr Reddy's to having the necessary quantities required for the trial? What are the advantages of having Dr Reddy's perform this production for Cellceutix?
We are now having Dr Reddy's produce enough material for our all needs through the Proof of Concept trial and a phase II/III trial. As of our recent meeting with them, production is on schedule for us to be ready for trials in the first half of this year as we planned. As I just mentioned, they are intimately involved with the active ingredient of Prurisol, which allowed them to shave several steps off the manufacturing process, saving both time and money. Dr. Reddy's produces medicines for many of the worlds largest drug manufacturers, names we are all familiar with. Their staff resources are enormous and complete with many PhD's available to work on our project. This depth gave us a high degree of comfort that this project will be successfully completed.
If the phase 2/3 trial is successful, what are your planned next steps for Prurisol? What do you feel will offer the best value for shareholders from a licensing/acquisition standpoint?
I believe you are referencing the initial Proof of Concept clinical trial, which we anticipate will be completed relatively soon. There are many possible scenarios based on the results of the trial. If the data is positive as we hope it will be, it's foreseeable that we should have any number of possibilities to take Prurisol further down the regulatory pathway. We could develop it on our own or entertain licensing agreements if the terms are acceptable to the company and our shareholders. If the results of the initial trial are unfavorable, we of course would have some decisions to make in that regard as well. Obviously, we have a high degree of expectations as we will have produced all of the drug needed for a phase II/III trial, but we are aware of all possibilities. It is simply a bridge that we will cross when we get there.
http://seekingalpha.com/article/1113011-q-and...s-compound
“Psoriasis- A successful Phase 2 study with very good efficacy and low toxicity can become a 0.5 billion dollar value. A successful Phase 3 with good efficacy and low toxicity can become a 2+ billion dollar value.”
TLSR: We have not talked much about Prurisol. Would you give a little background on that compound?
LE: Prurisol is a prodrug of a marketed drug called abacavir sulfate (Ziagen; GlaxoSmithKline [GSK:NYSE]), a nucleoside analog that has been phenomenal for treating HIV. It's a reverse transcriptase inhibitor, and was originally approved in the U.S. back in 1998. We have made changes to the molecule, but because of its similarity and long use in humans, it is eligible for the FDA's 505(b)(2) drug approval pathway, which is an abbreviated pathway for a drug already in use. This drug is actually the longest shot we have because the Phase 2 trial is the first treating psoriatic patients, and we will begin getting human data around the end of April. It's a double-blind study, so we don't know anything at this point. The path forward is quite logical, though. If the drug performs like abacavir, one might be inclined to think that there won't be activity against psoriasis. However, based on preclinical animal studies, for which we have published images of mouse models, we do expect Prurisol activity in this study. So the path is: Study the data including safety, determine which dose of the three did best, see time points when improvements occurred, and if warranted, proceed to further advanced clinical studies (i.e. Phase 2b/3 or Phase 3).
http://www.thelifesciencesreport.com/pub/na/a...-jorgensen
“Given that psoriasis is a chronic condition with limited effective therapies that the National Psoriasis Foundation lists as affecting 125 million people worldwide, we see a tremendous market opportunity for an effective new oral treatment. As previously reported, enrollment in the Phase 2 trial was completed in November and we are expecting top-line data in April/May 2016.”
http://cellceutix.com/best-yet-to-come/#sthash.b1XlMghR.dpuf
“The goal is to show the compound is safe and effective, while pointing us to an optimal dosing regimen for a late-stage trial. For the good of the millions of people suffering from psoriasis, we hope that Prurisol can one day provide a much-needed option to often-used biologics that are known to have side effects and contraindications, while eventually losing effectiveness in many patients.”
http://cellceutix.com/cellceutix-phase-2-tria...Ped57.dpuf
You have frequently spoken of Kevetrin as being unique and novel due to its revolutionary mechanism of action that activates the P53 gene. What unique or compelling advantage does Prurisol offer over existing treatments or competing anti-psoriasis compounds that are also currently in clinical trials?
It is too early for us to compare Prurisol to other competing compounds in clinical trials. We do know the toxicity profile of Prurisol, but we don't know the profiles of the other drugs as they are not yet publicly available. What most impressed us about Prurisol in the animal studies was not simply that the psoriasis was visually eliminated, but that the psoriasis did not recur. There are many fine drugs out there to rid psoriatic lesions, but the results are temporary. Thereafter the individual will build resistance to the drug and it will become ineffective. Additionally, the problem with the biologic drugs is the potential for serious side effects. A new drug is urgently needed to help those suffering from psoriasis, which is a very uncomfortable and sometimes debilitating disease affecting millions of people in the U.S. alone.
Dr. Krishna Menon, the intellectual powerhouse behind the development of the compound, is widely respected for his keen ability to identify successful compounds in a crowded sea of possibilities. What compelled Dr. Menon to put his energy and innovative approach into Prurisol?
The idea for a psoriasis drug actually came from others and we licensed their compound. However it wasn't achieving the results we had hoped for. Cellceutix thereafter developed Prurisol. Once the patent is published, people will have a better understanding of our thought process in the development of Prurisol and how we accomplished making this new compound. At this time, we are keeping our intellectual property close to the vest until it is properly protected.
What gives you confidence that the dramatic results shown so far in your lab studies will be achieved in human testing?
Of course, things can be different in humans as compared to animal research, but by utilizing mice with compromised immune systems and human xenograph models, we replicated the conditions as closely as possible in the laboratory studies. This is a recognized methodology in animal models for preclinical testing. Also, Dr. Menon's decades' of experience and understanding of the chemistry of the drug and his knowledge of the pathology of the lab studies lends a great deal of validation and confidence heading into human trials.
Dr Reddy's Labs was your choice to synthesize and manufacture Prurisol in preparation for the upcoming clinical trial. What was the logic behind selecting Dr Reddy's for this process?
Dr Reddy's is the second largest drug producer in India. They are a New York Stock Exchange listed company with a market cap of over five billion dollars ($5,000,000,000). They are among the world's largest manufacturers of the starting active pharmaceutical ingredient in Prurisol. Therefore, their familiarity in producing a product such as Prurisol is second to none.
How close is Dr Reddy's to having the necessary quantities required for the trial? What are the advantages of having Dr Reddy's perform this production for Cellceutix?
We are now having Dr Reddy's produce enough material for our all needs through the Proof of Concept trial and a phase II/III trial. As of our recent meeting with them, production is on schedule for us to be ready for trials in the first half of this year as we planned. As I just mentioned, they are intimately involved with the active ingredient of Prurisol, which allowed them to shave several steps off the manufacturing process, saving both time and money. Dr. Reddy's produces medicines for many of the worlds largest drug manufacturers, names we are all familiar with. Their staff resources are enormous and complete with many PhD's available to work on our project. This depth gave us a high degree of comfort that this project will be successfully completed.
If the phase 2/3 trial is successful, what are your planned next steps for Prurisol? What do you feel will offer the best value for shareholders from a licensing/acquisition standpoint?
I believe you are referencing the initial Proof of Concept clinical trial, which we anticipate will be completed relatively soon. There are many possible scenarios based on the results of the trial. If the data is positive as we hope it will be, it's foreseeable that we should have any number of possibilities to take Prurisol further down the regulatory pathway. We could develop it on our own or entertain licensing agreements if the terms are acceptable to the company and our shareholders. If the results of the initial trial are unfavorable, we of course would have some decisions to make in that regard as well. Obviously, we have a high degree of expectations as we will have produced all of the drug needed for a phase II/III trial, but we are aware of all possibilities. It is simply a bridge that we will cross when we get there.
http://seekingalpha.com/article/1113011-q-and...s-compound
“Psoriasis- A successful Phase 2 study with very good efficacy and low toxicity can become a 0.5 billion dollar value. A successful Phase 3 with good efficacy and low toxicity can become a 2+ billion dollar value.”
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