CTIC has roughly $6.50/share in cash and trades for a buck less. Insiders bought in April, apparently on belief Xyotax works. Others aren't so sure, hence the opportunity. And even if it does, aren't there a host of other taxanes as well as other compounds, that will work as well or better? As has been pointed out, trading for less than cash doesn't help much if there is significant burn. But CTIC has ~$235 million, so it shouldn't run out for some time. I don't follow them and couldn't guess at their chances.
>>SEATTLE, June 4 /PRNewswire-FirstCall/ -- In a meeting with the Food and Drug Administration (FDA) at the end of May, Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC - News) reviewed summary results of XYOTAX (polyglutamate paclitaxel) phase II clinical trials and planned phase III clinical trials in non-small cell lung and ovarian cancers. As a result of feedback from the FDA at the meeting, the Company is now in the final stages of clinical protocol refinement for XYOTAX in patients with non-small cell lung and ovarian cancers. Consistent with regulatory guidelines pending final review by the FDA of the phase III protocols, the Company anticipates initiating the phase III trials this summer, with its first NDA (New Drug Application) submission targeted for the second half of 2004 in accordance with previous corporate projections.
"Our meeting with the FDA validates our clinical strategy for XYOTAX," stated James A. Bianco, M.D., President and CEO of CTI. "We reached agreement on several key trial parameters, including the importance of survival and clinical benefit as meaningful endpoints in lung cancer, the choice of dose for both the lung and ovarian studies, and the endpoints for and ability to initiate a front-line study in ovarian cancer based on the safety and efficacy data of XYOTAX alone and in combination with platinates. We were genuinely pleased with the guidance and encouragement provided by the FDA and their willingness to work with the Company," added Bianco.
Non-Small Cell Lung Cancer Phase III Clinical Trial
The phase III clinical trial of XYOTAX in non-small cell lung cancer will be conducted among patients who have relapsed following a platinum-based front-line treatment. This international randomized open-label study will be designed to demonstrate that XYOTAX results in superior survival when compared to docetaxel, the current approved single-agent treatment.
Ovarian Cancer Phase III Clinical Trial
The phase III clinical trial of XYOTAX in ovarian cancer will be conducted among patients with newly diagnosed advanced ovarian cancer. This international randomized open-label study will compare XYOTAX (210 mg/m2) plus carboplatin to the standard front-line treatment of paclitaxel (175 mg/m2) plus carboplatin. Patients who achieve a complete remission will be allowed to receive monthly maintenance doses of XYOTAX or paclitaxel until disease progression. Progression-free survival and a superior side effect profile are the objectives of the study.<<
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Cheers, Tuck |
