Biotech Values

[bladerunner1717]

Clark, (re: ECYT)

This is from an interview with Ron Ellis, CEO of ECYT. Do you buy his explanation?


DS: The market reacted quite negatively to your phase II platinum resistance ovarian cancer (PROC) data at the end of 2011. What explains the change in the overall survival (OS) and why do you feel the reaction was overdone?

RE: First, the phase 2 study was conducted in platinum resistant ovarian cancer. This is a a very challenging patient population. Prior to vintafolide, no drug has demonstrated an improvement in either survival or delayed disease progression. Survival is approximately 12 months and the FR positive patients, the patients we target, have an even worse prognosis. This is probably because these FR rich cells are dividing more rapidly.

The study enrolled both FR positive and FR negative patients. It was an all-comers study. We included the FR negative patients, as requested by the FDA, as part of the validation of the companion imaging diagnostic. Even with FR negative patients included, the study met the primary endpoint of delaying disease progression in all patients, but more importantly it demonstrated that the FR negative patients didn't benefit from vintafolide therapy while the patients with all tumors positive for the receptor showed a significant benefit (HR 0.381 p=0.018). These results provide proof of principle of this technology in a very difficult patient population.

As reported we did not see an improvement in overall survival. However, as we pointed out, the study was not powered for OS analysis so no definitive conclusions can be drawn from these data. The lack of OS benefit appeared to be an issue with a longer than expected survival in the control arm. There may be a few reasons. First, the study used a 2:1 randomiziation, so we had 100 patients in the treatment arm and only 49 in the control arm, so a much smaller sample for the ccntrol arm. The control arm received more post-study therapy than treatment arm and the control arm patients had a better prognosis than the treatment arm. In fact when adjusted for these prognostic factors the HR for patients with all FR positive tumors was below 0.50. These OS issues will be addressed in the larger phase 3 trial with a 1:1 randomization.


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