In late September, Cell Therapeutics (CTIC) announced that a second independent radiologic review of data from the pivotal trial PIX301 of lead drug pixantrone for aggressive NHL confirmed the statistical significance of response and progression endpoints. With this positive development, we believe pixantrone is getting closer to approval.
We are encouraged by the FDA’s decision to allow Cell Therapeutics to re-submit the NDA for pixantrone for review without the need for an additional trial. We are therefore upgrading our rating on the stock from Neutral to Outperform.
Cell Therapeutics second most advanced pipeline candidate, Opaxio, is being studied as a potential maintenance therapy for women with advanced ovarian cancer who achieve complete remission following first-line therapy with paclitaxel and carboplatin. The phase III study, GOG0212, has already enrolled more than 800 of the planned 1,100 patients targeted.
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