According to Leo, the current dosage for cohort 4 is 50 mg/m2, and it will double to 100 mg/m2 in cohort 5. They are also considering dosing cohort 5 twice a week instead of once. The expected dosage for efficacy in humans is between 100 mg/m2 and 200 mg/m2.
Some posters here said the efficacy dosage in humans was as high as 600 mg/m2. This goes to show that no one knows it all. Do your own DD. Consider the source.
Leo said two doses per week would be in later Phases not later cohorts. The current Phase 1 will remain at one dose per week. I can't see changing the protocol in a Phase 1 study where the primary outcome is determining safety and not efficacy. From what Leo said, I think it was hard enough just to get back to higher rates of escalation from cohort to cohort.
LOL! And what did your DD tell you? That efficacy was possible in Cohort 2 per TOB's ridiculous man vs. mouse post?!?!?! I said no efficacy in tumor shrinkage under 150mg/m2. Now we hear hoping to see efficacy somewhere in the 100-200mg/m2 range. Guess what that lines up with - THE MOUSE MODEL!!!! That is the START of predicted efficacy. Full effective dose is still 600mg/m2 range per the MOUSE MODEL!!!.
Some foolish iflubbers trying to rewrite history here and misinterpreting prior posts.
I agree. The company is saying all it can. I believe we are seeing the p21 biomarker also but with such small doses, the company needs more data, higher dosing, to firm it up for public consumption. Why else would we get this comment in the recent PR of a week ago: "We are very pleased with the results to date especially considering the lower doses to date." This is definitely not a comment about the drug proving its safety, it is directed to signs of efficacy already appearing.