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: Biomaven who wrote (9672)	12/5/2003 5:24:40 PM
From: Icebrg	Respond to of 52153

Peter Sitting here with my CTIC hat on, I feel I have to question if these results are truly good or not. I find it disappointing that they don't specify what types of responses they saw. I guess that their Overall Tumor Response Rate spans everything from stable disease to complete response. But we don't know how much of each. They have also chosen only to measure the time to tumor progression. But we don't know if the 5 weeks advantage seen at this point can also be translated into a clinical benefit of statistical significance in the more important endpoint of medium survival time. Lehman recently noted the following in a pre-conference discussion on the subject of Abraxane vs. Xyotax. Not that it matters so much at this time as Xyotax is tested in a completely different indication. Erik Lehman quote: We believe that Xyotax and Abraxane are very similar paclitaxel conjugates that are both water soluble, designed to penetrate selectively leaky tumor vasculature and both with evidence of anti-tumor activity with lesser toxicity than regular paclitaxel. As such we believe that true differentiation will come from optimization of dose, adequacy of trial design and support of oncologists that have relied on traditional paclitaxel for years. While Abraxane may be slightly ahead of Xyotax in terms of generating phase III data we believe that CTIC still retains the edge in all other categories including dose optimization, trial design and opinion leader support. Indeed, with the support of the GOG in ovarian cancer and 3 major survival studies ongoing in NSCLC we believe that CTIC has taken the high road in product development and will ultimately determine whether paclitaxel analogues get used at all. On the contrary we do not believe that a 505b2 filing, even if accepted, will support the replacement of paclitaxel with Abraxane, particularly given the unusually low response rates seen in the paclitaxel comparator arm in the APPX studies which will lead the FDA and clinicians to question how representative the data truly is.