From 2 years ago and what stood out for me till th
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Posted On: 05/09/2018 7:04:43 PM
From 2 years ago and what stood out for me till this day to "Prurisol" and it could become a game changer to healing psoriasis as we wait for trail unbinding data any day coming!!!...filed with the sec exhibit 99.1 by Innovation Pharmaceuticals - [Cellceutix]:»
Q: Many shareholders assumed Cellceutix-[Innovation Pharmaceuticals] was going into a Phase 3 trial with Prurisol TM. Why the decision to conduct a Phase 2b? Isn't there more value in a Phase 3 drug?
"A: Everyone likes to hear "Phase 3," as it implies nearing a New Drug Application with the FDA and potential commercialization. However, jumping right into Phase 3 studies without being properly aligned is not the best strategy to efficiently develop a drug and truly grow value and attract partners. The data from the first Phase 2 trial is very impressive and clearly showed a stronger therapeutic benefit at the 200mg dosing level in patients with moderate psoriasis, as measured by the Investigator's Global Assessment scale. I am very excited about the results that already suggest benefit starts at 2 weeks and further improves by the end of the study at 12 weeks. Let's say that this gave us a great 15,000-foot view of Prurisol TM activity. This is what an initial Phase 2 trial is for. The data certainly point to an even stronger clinical benefit at higher doses in patients with more severe disease. The purpose of the Phase 2b trial in patients with moderate to severe psoriasis is to better define dosing, examine responses using endpoint(s) that will be used in Phase 3 pivotal trials and to gain further experience with safety.
By studying Prurisol TM in this patient population and incorporating the Psoriasis Area and Severity Index (PASI) scoring method, we are generating a better perspective of Prurisol TM against historical performance of the approved oral drug, OtezlaÒ, as well as the most potent drugs on the market today, the injectable biologics. That is an important step towards generating exactly what big pharma and the FDA will want to see. There is a rare opportunity here because patients often prefer oral drugs to injections. The data from OtezlaÒ with respect to patients achieving a PASI 75 score is published and will likely serve as an important benchmark for us. If we can show Prurisol TM to be as effective or better than OtezlaÒ, Prurisol TM should command tremendous value. I believe that companies with marketed biologics will be interested in adding a new, safe and efficacious oral drug to their marketing arsenal and that others looking to enter the psoriasis space will take notice as well. We are not going to leave this type of opportunity on the table by rushing prematurely into Phase 3.
So, to answer your question about more value in a Phase 3 drug, we're not just looking for "more" value; the way we're setting it up, we're looking to "maximize" value. " ....IPIX - Gotta be in it to win it! , all imho.......enjoy,tryz
Q: Many shareholders assumed Cellceutix-[Innovation Pharmaceuticals] was going into a Phase 3 trial with Prurisol TM. Why the decision to conduct a Phase 2b? Isn't there more value in a Phase 3 drug?
"A: Everyone likes to hear "Phase 3," as it implies nearing a New Drug Application with the FDA and potential commercialization. However, jumping right into Phase 3 studies without being properly aligned is not the best strategy to efficiently develop a drug and truly grow value and attract partners. The data from the first Phase 2 trial is very impressive and clearly showed a stronger therapeutic benefit at the 200mg dosing level in patients with moderate psoriasis, as measured by the Investigator's Global Assessment scale. I am very excited about the results that already suggest benefit starts at 2 weeks and further improves by the end of the study at 12 weeks. Let's say that this gave us a great 15,000-foot view of Prurisol TM activity. This is what an initial Phase 2 trial is for. The data certainly point to an even stronger clinical benefit at higher doses in patients with more severe disease. The purpose of the Phase 2b trial in patients with moderate to severe psoriasis is to better define dosing, examine responses using endpoint(s) that will be used in Phase 3 pivotal trials and to gain further experience with safety.
By studying Prurisol TM in this patient population and incorporating the Psoriasis Area and Severity Index (PASI) scoring method, we are generating a better perspective of Prurisol TM against historical performance of the approved oral drug, OtezlaÒ, as well as the most potent drugs on the market today, the injectable biologics. That is an important step towards generating exactly what big pharma and the FDA will want to see. There is a rare opportunity here because patients often prefer oral drugs to injections. The data from OtezlaÒ with respect to patients achieving a PASI 75 score is published and will likely serve as an important benchmark for us. If we can show Prurisol TM to be as effective or better than OtezlaÒ, Prurisol TM should command tremendous value. I believe that companies with marketed biologics will be interested in adding a new, safe and efficacious oral drug to their marketing arsenal and that others looking to enter the psoriasis space will take notice as well. We are not going to leave this type of opportunity on the table by rushing prematurely into Phase 3.
So, to answer your question about more value in a Phase 3 drug, we're not just looking for "more" value; the way we're setting it up, we're looking to "maximize" value. " ....IPIX - Gotta be in it to win it! , all imho.......enjoy,tryz
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