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 : Oncothyreon -- Ignore unavailable to you. Want to Upgrade?

To: biomachine56 who wrote (2177)	5/23/2013 2:59:52 PM
From: scaram(o)uche	Read Replies (1) \| Respond to of 2344

Nice summary, thanks!

To: biomachine56 who wrote (2177)	5/28/2013 10:59:45 AM
From: biomachine56	Respond to of 2344

The ORR primary aside, the established PFS in CTX monotherapy in irinotecan/oxaliplatin refractory mCRC pts appears to be ~4M +/- 1M at best. Last patient enrolled in the PX866/CTX combo study was June 2012.

To: biomachine56 who wrote (2177)	5/28/2013 7:55:49 PM
From: biomachine56	Read Replies (1) \| Respond to of 2344

PX866/CTX combo in mCRC is in refractory pts (failed irinotecan and oxaliplatin) in a controlled and randomized study. ORR data for refractory indications.... Crizotinib as a recent example....approved on ORR from single arm studies. cancer.gov The approval was based on two single-arm trials, Study A (N = 136 patients) and Study B (N = 119 patients). The primary endpoint of both trials was objective response rate (ORR) as assessed by the investigator. In Study A, the ORR was 50 percent (95 percent CI: 42 percent, 59 percent) with a median response duration of 42 weeks. In Study B, the ORR was 61 percent (95 percent CI: 52 percent, 70 percent) with a median response duration of 48 weeks. Complete responses were observed in 1 percent of patients. An interesting read....Pazdur jco.ascopubs.org In subsequent years, the FDA stated that under selected circumstances, impressive tumor-related outcomes could be considered clinical bene?t. Look at Table 1. Table 1. Surrogate End Point Status and Marketing Approval End Point Status ---- Example ---- Type of Approval Reasonably likely surrogate ---- Response rate in refractory solid tumors ---- Accelerated approval Ten of the 14 AAs were based on tumor responses in single-arm phase II studies in refractory cancers.