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Biotech / Medical : Cell Therapeutics (CTIC) -- Ignore unavailable to you. Want to Upgrade?

To: Clarksterh who wrote (389)	1/29/2005 1:08:15 PM
From: gcrispin	Respond to of 946

Thanks for providing the link to the study. Although the GOG study has generally been considered a no-brainer for Xyotax, that suggestion is even more evident from the discussion section of the study. I found this section interesting, however. <The decision to use a short-course (three cycles) paclitaxel control arm, rather than a no-further-treatment control, was made for both practical and theoretical considerations. Despite the absence of definitive randomized controlled trial data demonstrating any value for consolidation or maintenance therapy in women with ovarian cancer who achieved a clinically defined complete response, there was concern that when women were presented with the justification for the conduct of this trial, few would accept randomization to a no-treatment control. This assessment resulted from the fact that patients considered for entry onto this trial would need to be told the following: (1) approximately 75% of patients in this clinical setting ultimately experience recurrence of their cancer1,2,12; (2) if disease recurs, there is no evidence for the curative potential of any second-line regimen; (3) the drug they would receive in the trial (paclitaxel) was a component of the regimen to which they had already attained a clinical complete response and tolerated (otherwise, they would not be a candidate for the trial); (4) there is currently evidence that paclitaxel can be given safely for extended periods9; and (5) a reasonable rationale could be presented to support the potential clinical utility of extending the duration of paclitaxel administration (eg, exposure of tumor during active cell cycling13; antiangiogenetic effect associated with continued intermittent drug exposure14). Finally, because paclitaxel was commercially available when this trial was initiated, a patient presented with this information could simply elect to ask her oncologist to administer additional cycles of the agent. However, as the study was ultimately designed, it could be rationally (and ethically) argued that even patients randomized to a three-cycle control arm would be receiving some additional treatment beyond that known to be associated with an extremely high recurrence rate.> Since the control arm is to receive no treatment in GOG sponsored study, I wonder if this is one of the obstacles they face in getting this trial started. Just speculation on my part. BTW, I've read your comments concerning pricing on the Yahoo board. In the past, Bianco has stated that Xyotax would be a premium-priced taxane, and mentioned Taxotere in the same sentence. Looking at the pricing of Taxotere could give you a rough idea of what Xyotax would be priced, depending, of course, on the outcome of Stellar 2, and all the Stellar trials, for that matter.