Will Cell Therapeutics Ever Go Away?

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At some point, the Seattle biotech company Cell Therapeutics Inc (CTI) should earn an entry in the Guinness Book of World Records for utter and complete futility as a business.

It's hard to fathom, but despite being in business for two decades, the company has yet to spin a profit. In that time frame however, they have managed to spend roughly $1.5 billion.

$1.5 billion. Divide that by twenty and you learn that annually, CTI spends on average $75 million. On what???

Lawsuits and kickbacks

Well, we know they've dropped a few million dollars settling civil breach of contract lawsuits.

We also know they paid kickbacks to doctors who frequently prescribed the drug Trisenox (arsenic trioxide) off-label to patients with a variety of cancers for which Trisenox was not FDA-approved. Without admitting guilt, they paid about $10 million to make that unspeakably immoral and unconscionable act go away.

They dropped a few bucks to buy part-ownership of the highly innovative radioimmunotherapy treatment for indolent non-Hodgkin's lymphomas, Zevalin. But after about a year they must have suspected Zevalin was some sort of hot potato because they dropped it. Fortunately, a much wiser biotech controls Zevalin and is doing a lot of the right things with this therapeutic regimen. Looking back, CTI wasn't the right fit anyway, but the fact that they would show no patience with the treatment says something less than flattering about them.

Most recently, CTI settled a class action lawsuit brought against them by their shareholders for a breezy $19 million. The lawsuit alleged that company principals including CEO James Bianco committed securities fraud and lied to shareholders about important milestones in the development of the company's lead oncology product, pixantrone.

Pixantrone

The molecular disaster known as pixantrone (marketed as Pixurvi) is pitched by CTI as a third-line (or a 'second- to fourth-line') therapy for aggressive, refractory B-cell non-Hodgkin lymphomas. The only reason they have garnered any regulatory attention at all in this endeavor is because there is no other third-line option for these patients.

I shudder to think of how much money they have sunk into this underperforming underachiever. To say that US regulators have given pixantrone the thumbs down is an understatement: In 2010 CTI presented results of its Phase III trial of pixantrone to the FDA's Oncologic Drugs Advisory Committee (ODAC). This committee unanimously voted 9-0 to reject CTI's New Drug Application. Director Richard Pazdur and colleagues at the FDA don't have to follow the recommendation of the committee, but they generally do, and this time they did. Pazdur even read CTI the riot act for submitting results from such an unprofessional and poorly conducted trial. He even alleged that some of the patients involved in the trial did not have aggressive disease.

Eurotrash

Despite this, the drug received conditional marketing authorization by the European Commission in May of this year. So far, the FDA has stood firm, and pixantrone remains unapproved in the United States. Pixurvi is thus oncological Eurotrash, and Eurotrash only.

I've written about the Seattle biotech company before ("Cell Therapeutics & Pixantrone: Putting the B.O. in biotech" and "The other 70 percent"), in increasingly unflattering terms. Should they take another shot at FDA approval, for my part I will come out against it with both barrels blazing.

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