Can you explain in layman's terms what going to ph
Post# of 148112
Quote:
Can you explain in layman's terms what going to phase II means for LL and CYDY.
What % of drugs make it that far and what % advance beyond that? Things along those lines.
I don't think percentage that get that far or progress further is a good metric for leronlimab. Phase 1 trials are focused on safety. As long as a drug isn't killing people or making them seriously ill and there is a narrative of why it might work in a disease it can go on to a Phase 2. A lot of those narratives are based on a weak set off facts and the drugs fail badly in the phase 2 so never go on to a Phase 3.
Even after being put on a safety hold for 2 1/2 years leronlimab isn't doing a Phase 1, our safety is impeccable. Studies and trials with CCR5 and cancer including our own prove out the mechanism of action. Getting a Phase 2 for mssCRC was obvious it was just a matter of quibbling over details. With a high expression of CCR5 in mssCRC and a proven MOA the only things I can see that would stop an advance to Phase 3 would be a very small patient population or skewed patient balance. CCR5 delta 32 double allele deletion patients should be excluded. If single allele deletion patients are allowed they must be balanced between arms.