>> is going from 33% to 26% 2 mos to 4mos something to get excited about? Will the same "downhill" results with the present testing be considered compelling? <<
GENR’s data from the Mexican trial were unquestionably outstanding. 33% of patients had improved vision at 2 months, and 26% still had improved vision at 4 months. Improved vision was defined as a gain of 3+ lines (15 letters) relative to baseline, an outcome that is almost medically impossible from a placebo effect or chance.
In the Mexican trial, the drop-off from 33% to 26% during the final two months of observation was not troubling because there was no treatment in that trial after the four initial weekly infusions. In other words, having 26% of patients with improved vision at 4 months was damn good because the patients had not received any Squalamine for the last three months of the study.
Using a different metric, the mean change in visual acuity for all patients evaluated, the Mexican trial had values of +1.8 lines at the end of treatment, +1.4 lines at 2 months, and +1.2 lines at 4 months. (Please see slide #50 in #msg-1605364.)
Note that these values are lines, not letters! Using the 1:5 conversion from lines to letters, patients in the Mexican trial had a mean gain relative to baseline of 9 letters at the end of treatment, 7 letters at 2 months, and 6 letters at 4 months.
In contrast, in the 10mg data from the phase-2 “207” study reported at the recent Rodman & Renchaw conference (#msg-4420204), the mean gain reached 4 letters after the first two weekly infusions (the “week 3” column in the bottommost row of slide #50), but then the mean gain started to decline even though patients were still being treated weekly at that point in the study. By the end of the four weekly infusions, the mean gain had dropped to 2.5 letters (the “EOT” column). One month later (the “2 months” column), the mean gain had already become a mean loss of 1.5 letters.
Of course, one would not expect as robust an outcome using 10mg as was achieved at 40mg and 80mg in the Mexican trial. What I find curious is that 10mg is clearly too low for decent efficacy, yet it was the 10mg data that GENR elected to show to Wall Street at the Rodman & Renchaw conference.
>> It seems to be going in the wrong direction, especially if compared to Lucentis 45%,34%. <<
Please be careful: in the phase-1/2 Lucentis trial, the 45% and 34% figures were two different ways of analyzing the same data (per-protocol and intent-to-treat, respectively), not data from two different time points as you surmised.
>> If anything, what's in GENRs favor? <<
GENR still has the advantage relative to Macugen and Lucentis in the method of administration. But this advantage will be relevant only if Squalamine proves to be safe and effective at the doses being tested.
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