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Biotech / Medical : Biotech Valuation

CRSP 54.58

-1.0%

Nov 10 3:59 PM EST

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To: Sam Citron who wrote (16029)	3/7/2005 11:03:57 AM
From: Sam Citron	Read Replies (1) of 52153

More from Hambrecht's Jan 21 report with the bullish case highlighted: Cell Therapeutics is running one of the most robust clinical development programs for Xyotax in first and second-line non-small cell lung cancer. Three Phase III trials test Xyotax as a first-line agent in performance status 2 (PS2) patients either alone (STELLAR 4) or in combination with carboplatin (STELLAR 3) and as a single agent for refractory patients (STELLAR 2). * All three trials are randomized with a standard of care active control. * All three trials are designed as superiority trials with survival as the primary endpoint. * All three trials are fully enrolled. The timing of the data is event-driven, requiring a pre-specified number of deaths in the trial. * Data from all three trials is expected in 2005, with the company guiding the first results in late Q1 or early Q2:05 from STELLAR 3. * Each of the three trials is sufficient for FDA approval. The rationale for these trials is well founded: 1) Xyotax is easier to administer and less toxic (less neutropenia, less hair loss) than Taxol; 2) PS2 patients do not tolerate chemotherapy well and often discontinue treatment or reduce the dose of chemotherapy, leading to poor outcomes; 3) by administering a more tolerable and potentially more potent taxane (Xyotax), it may be possible to keep patients on full-dose therapy longer and extend clinical benefit. We believe that Xyotax has a good chance of demonstrating superiority, which would be sufficient for regulatory approval in any of the three trials. If it does not, we believe the totality of the data from the three trials could be sufficient for regulatory approval if Xyotax demonstrates a consistent safety benefit and a trend towards improved clinical outcome.

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