A couple of other keys besides the above mentioned on the phase 1 breastcancer full analysis follow.
Between groups:
So 3 groups (cohorts) each approx. 9 participants each.
The first group dosed at 25mg of the ptx200 compound.
The second group dosed at 35mg, same for the third group (extended cohort)
FDA safety and granting of the Phase 2 at 35mg ( interim data Ann 2017), implied the second group (between groups) results were best where ORR>25% ( in fact of memory greater than 80%). Hence, greater potency.
Within groups:
The second cohort and the third cohort comparison is important. Repeated measures within, would signify generalisation.
So, an overall ORR within groups invariably would signify strong results at a phase 1 level.
A note of awareness is required here.
No intention is implied on population comparison between phase studies.
That is, a phase 2 and phase 3 study require a greater amount of participants accordingly, hence greater population generalisation in statistical and clinical significances.
Hope these keys help some when the imminent analysis goes public.
PTX Price at posting:
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