trding, I hardly doubt there will be a placebo arm
Post# of 154332
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Posted On: 02/05/2019 9:31:19 AM
trding, I hardly doubt there will be a placebo arm in ph2 - b/c that is not ethical.
But I assume the other trials did, otherwise you wouldn't have mentioned it.
I agree, same as w/ HIV-1, blocking ccr5 should occur ASAP for best results.
So if done w/ very sick patients - one would really need to be look at the fine differences.
So that is more hard on the trial design, since you cannot expect those patients all of a sudden to be healed completely. I saw similar things w/ other cancer trials.
Most important w/ these trial IMHO is to define success.
Also: The higher the cancer cell count, the higher CCR5 count and hence the need for higher PRO 140 dosage - see earlier posts re CCR5 Occupancy.
My science peer said this about the trial, they should use IV PRO 140 injection w/ very flexible dose escalation up to 10 times of 10mg/kg body mass for 4 weeks, knowing that 10mg/kg represent full occupancy for T-cells only.
EDIT: 700mg is about 3x said 10mg/kg for a 100kg patient (o8>
But I assume the other trials did, otherwise you wouldn't have mentioned it.
I agree, same as w/ HIV-1, blocking ccr5 should occur ASAP for best results.
So if done w/ very sick patients - one would really need to be look at the fine differences.
So that is more hard on the trial design, since you cannot expect those patients all of a sudden to be healed completely. I saw similar things w/ other cancer trials.
Most important w/ these trial IMHO is to define success.
Also: The higher the cancer cell count, the higher CCR5 count and hence the need for higher PRO 140 dosage - see earlier posts re CCR5 Occupancy.
My science peer said this about the trial, they should use IV PRO 140 injection w/ very flexible dose escalation up to 10 times of 10mg/kg body mass for 4 weeks, knowing that 10mg/kg represent full occupancy for T-cells only.
EDIT: 700mg is about 3x said 10mg/kg for a 100kg patient (o8>
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