Bhag,
I'm running out to a meeting, so I'll try to cover this quickly without too many mistakes ... : )
Here's my understanding on the PII/III plan for 3340.
First, it's designed as a pivotal trial. A calculated risk.
NSCLC and prostate cancer. NSCLC is more promising to get early registration quality data, since the time to progression [note: I'd said "survival" in my earlier note. It looks like progression the endpoint"] is 6-9 months (prostate is slower ... however the market for prostate is larger).
Three doses. 5mg, 10mg, 15mg, all BID, in combo with standard therapy (Taxol and carboplatin).
At the 5mg BID (low dose), expect to be able to inhibit the MMPs associated with cancer, but expect it to be well tolerated. 15mg BID (high dose) expect to see some side effects (perhaps 30% with some joint pain at Marimistat levels). 50 patients at each of the three dose levels, plus 50 on placebo. There will be an interim analysis to define the appropriate dose. At that point, they expect to add c. 115 patients to the two arms selected to proceed. Time to progression is the primary endpoint (defined radiographically), but they will follow the patients to gather survival data. 40 to 60 centers, probably at the higher end.
In PI, they didn't see substantial acute responses (which they did not expect, given the late stage of the patients and the nature of therapy). What they did see, beyond the PK and safety data, was patients with pronounced stable disease.
gotta run ...
Peter |
