My response to AmaFUD17.
sox040713 Wednesday, 12/27/17 01:45:15 PM
Re: Amatuer17 post# 210098
Post #210212 of 210213
I share your excitement on reading a new Kevetrin PR plus a new blog in the morning! Efficacy isn’t included because it’s a secondary endpoint and today’s PR is a preliminary analysis.
I can show you many examples in which theory turns out to be fact, so I’m not sure what your point is. Plaques are formed when beta-amyloids (proteins) are stuck together. Tumors are formed when cells won't stop dividing. While scientists still don't fully understand what lead to Alzheimer's (like which gene is responsible), they have a much better understanding of the relationship between p53 and cancer.
Oral K doesn’t need to start over because the safety and PK/PD data can be referenced. One big difference is oral K Phase 1 will enroll healthy volunteers.
“A next set in oral formulation development for Kevetrin, following preclinical data review by FDA and obtaining agreement to progress to humans is to perform an expedient Phase 1 trial in healthy adults using the oral route.
The ultimate goal with Kevetrin would be pill formulation that could be administered daily or even multiple times per day. This would leverage its pharmacokinetic profile.”
https://seekingalpha.com/article/4080068-inno...art=single
If K-OC has some impressive tumor response data, it won’t have a “very very long path” because IPIX can take advantage of FDA’s new initiative to approve a drug based on a biomarker. For K it could be p53/p21. IMO today’s PR is very significant because determining K’s MOA is a crucial step.
FDA approves first cancer treatment for any solid tumor with a specific genetic feature
“The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker) . This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated .”
https://www.fda.gov/newsevents/newsroom/press...560167.htm
sox040713 Wednesday, 12/27/17 01:45:15 PM
Re: Amatuer17 post# 210098
Post #210212 of 210213
I share your excitement on reading a new Kevetrin PR plus a new blog in the morning! Efficacy isn’t included because it’s a secondary endpoint and today’s PR is a preliminary analysis.
I can show you many examples in which theory turns out to be fact, so I’m not sure what your point is. Plaques are formed when beta-amyloids (proteins) are stuck together. Tumors are formed when cells won't stop dividing. While scientists still don't fully understand what lead to Alzheimer's (like which gene is responsible), they have a much better understanding of the relationship between p53 and cancer.
Oral K doesn’t need to start over because the safety and PK/PD data can be referenced. One big difference is oral K Phase 1 will enroll healthy volunteers.
“A next set in oral formulation development for Kevetrin, following preclinical data review by FDA and obtaining agreement to progress to humans is to perform an expedient Phase 1 trial in healthy adults using the oral route.
The ultimate goal with Kevetrin would be pill formulation that could be administered daily or even multiple times per day. This would leverage its pharmacokinetic profile.”
https://seekingalpha.com/article/4080068-inno...art=single
If K-OC has some impressive tumor response data, it won’t have a “very very long path” because IPIX can take advantage of FDA’s new initiative to approve a drug based on a biomarker. For K it could be p53/p21. IMO today’s PR is very significant because determining K’s MOA is a crucial step.
FDA approves first cancer treatment for any solid tumor with a specific genetic feature
“The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker) . This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated .”
https://www.fda.gov/newsevents/newsroom/press...560167.htm
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