Results, Setbacks

Years in the unmaking, CTI’s Pixuvri fails a pivotal PhIII combo study for lymphoma — can it remain on the market?

Seattle-based CTI BioPharma’s $CTIC years-long saga developing Pixuvri (pixantrone) has run into another stone wall. The company reported today that the drug, given conditional approval in Europe 6 years ago, failed a Phase III combination study in B-cell non-Hodgkin lymphoma.

James Bianco

Their drug combined with rituximab flunked a comparison with gemcitabine and rituximab in extending progression-free survival. Their stock immediately plunged more than 20%.

There are no data to assess. The results will be released later. The little biotech — formerly called Cell Therapeutics — began recruiting patients for this study more than 4 years ago.

Adam Craig

The company’s last quarterly report notes that CTI has accumulated a deficit of $2.2 billion over the years, with a little more than $104 million in reserves.

CTI had skated in and out of the danger zone — as well as penny stock territory — under former CEO James Bianco, raising funds and triggering going concern notices along the way. Novartis once had commercial rights to the drug, but handed it back in 2014. Servier picked up ex-US rights last year for €12 million and €76 million in milestones.

“We are disappointed with the outcome of the PIX306 trial and will proceed to conduct a thorough review of clinical data to assess the next steps for the PIXUVRI program,” commented CTI CEO Adam Craig.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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