Cell Therapeutics Gets FDA OK

Updated from 10:56 a.m. EDT

Cell Therapeutics' ( CTIC) treatment for relapsed, aggressive non-Hodgkin's lymphoma, or NHL, has shown so much promise in clinical trials that the Food & Drug Administration has granted it fast-track status, but shares failed to hang onto gains.

Cell Therapeutics announced Monday morning that pixantrone, a novel anthracenedione, was given the status after the drug's solid performance fighting NHL in phase I and phase II testing. Preliminary studies show that pixantrone caused remission in 20% of patients with NHL when used as a single agent and 59% remission when used as a part of the current front-line therapy.

In response to the news, shares of Cell Therapeutics spiked early in the trading day, gaining more than 7% before easing. Lately, shares were up a penny to $6.58, on 1 million shares traded, double their average daily volume of 475,000 shares.

"As there are currently no approved therapies for third-line aggressive non-Hodgkin's lymphoma we expected to obtain 'fast track' designation for this product," stated Jack Singer, chief medical officer of CTI. "The pivotal trial is well-designed and if successful, the efficacy and cardiac safety profile along with the drug's administration advantages may make pixantrone an important therapeutic for the potential treatment of aggressive NHL."

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