Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Agouron Pharmaceuticals (AGPH) -- Ignore unavailable to you. Want to Upgrade?

To: Bhag Karamchandani who wrote (4543)	6/23/1998 11:54:00 AM
From: Peter Singleton	Read Replies (2) \| Respond to of 6136

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