RE: Webcast27 Jul 2020 20:56
Thanks Haplo.
"A total of 84 patients were randomized of which 74 met criteria for the per protocol analysis. The mean change in BCVA from baseline to month 12 were +2.81, +2.96, and +7.43 letters in the sham (N=26), 3.0x106 hRPC (N=25), and 6.0x106 hRPC (N=23) treatment arms, respectively. In a post hoc exploratory analysis of the target subgroup (n=37), mean change in BCVA from baseline to month 12 were +1.85, -0.15, and +16.27 letters in the sham (N=13), 3.0x106 hRPC (N=13), and 6.0x106 hRPC (N=11) treatment arms, respectively (p=0.003 for 6.0x106 hRPC vs sham). Supportive improvements in the 6.0x106 hRPC target subgroup compared to the control (sham) group were also observed in all secondary endpoints which further support the BCVA findings in this subpopulation.."
I'm no expert but this seems like good news for RENE. The results across the whole population at month 12 were +2.81, +2.96, and +7.43 - the last being the highest dose of 6million cells. jCyte have then looked at a specific subpopulation and achieved +1.85, -0.15, and +16.27. A few things to note: (i) JCyte's efficacy appears dose dependant (ii) RENE's 2b results are comparable to the 6Million dose jCyte subpopulation figure, I believe (ii) RENE have improved the PH2a extension study design in several ways - - doubling cell count, changing the bleb location to avoid potential damage to functioning photoreceptors and using more sophisticated techniques for measuring efficacy (as used in Gene Therapy trials that lead to product approvals). These steps should further improve efficacy.
I'm sure we will hear from RENE's management team in due course on their thoughts.