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 : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (2842)	2/7/2001 2:32:09 PM
From: Biomaven	Read Replies (2) \| Respond to of 52153

Re. the speed needed to complete a phase I study. Fast may be bad. Agreed for a Phase I, but this is a Phase Ib - they've presumably already determined the MTD in Phase I and now all they are likely doing is looking at multiple dose PK etc. FWIW, here is the SCIO announcement on their Phase I results: “In its first clinical trial, SCIO-469 met our expectations,” said George Schreiner, M.D., Ph.D., chief scientific officer of Scios Inc. “SCIO-469 demonstrated excellent oral bioavailability and plasma pharmacokinetics. It was well-tolerated at a wide range of doses. We will evaluate SCIO-469 in additional safety and efficacy studies this year to further validate its potential for treating the millions of people who suffer from RA worldwide.” The objective of this Phase I, placebo-controlled, single dose trial was to evaluate the safety, tolerability and pharmacokinetic profile of six different doses of SCIO-469 in healthy volunteers. No significant adverse events were observed. In doses significantly greater than the anticipated therapeutic dose range, some patients experienced mild, transient side effects. So they went to 6 dose levels in the Phase I. Sounds like there were at least a couple above the anticipated dose range. FWIW, the Lehman/McKinsey report quoted some interesting statistics on traditional small molecule success rates: Phase 1: 70% chance of success Phase II: 50% Phase III: 70% FDA: 90% for a cumulative probability of a compound entering Phase I of about 15%. (These are for pharma, so probably should be lower for small biotech, especially at Phase III and the FDA). Peter