Cell Therapeutics Downplays Drug's Heart Risks

In other words, 36 pixantrone patients, or 56% of the total, didn't have end-of-treatment heart scans to assess for cardiac safety. Likewise, 64% of the patients in the comparator arm are left out of the heart toxicity analysis.

Where are all the missing patients for the cardiac safety assessment and why are they missing?

There's more. The same section of the poster also discloses that there was actually a 5% drop in LVEF amongst the 28 pixantrone patients at the end of the study.

So, what Cell Therapeutics is actually telling us about pixantrone's heart safety from this study is that they have complete data on 28 patients treated with pixantrone, and in these patients, their cardiac function (the ability of the heart to pump blood) actually decreased.

And what about the 23 patients in the comparator arm with complete heart safety data? Well, these patients actually improved by 1% in the LVEF.

Oh, and I should also mention that the patients in the comparator arm were previously treated with relatively higher doses of an anthracycline than the pixantrone patients before the study began. This should have pitched the cardiac toxicity assessment in pixantrone's favor, but it did not.

The incidence of serious cardiac disorders was 8.8% in the pixantrone arm compared to 4.5% in the comparator arm.

I haven't even addressed the efficacy of pixantrone, but there was little new information shed in today's presentation that wasn't previously disclosed by the company. An analysis of survival favored pixantrone-treated patients, but the result was nowhere close to being statistically significant, with a p value of 0.54. Statistical significance requires a p value of 0.05.

Bianco will probably still insist that pixantrone can be a $600 million drug or more and eventually replace all other anthracyclines in the treatment of lymphomas and other cancers. But based on the actual safety data -- not the press release version of same -- I'm quite comfortable sticking to my prediction that pixantrone is nothing more than a $50 million me-too cancer drug.

After today's stock price bump, Cell Therapeutics sports an enterprise value of $1.1 billion.

Now that's what I called over-valued.

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