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Biotech Stock Mailbag: Celsion

At a European thyroid research meeting last September, researchers reported that ATC patients treated with a combination of zybrestat and chemotherapy demonstrated a median overall survival of 5.1 months compared to a median overall survival of 4.1 months for similar patients treated with chemotherapy alone. While trending in the right direction, this survival benefit was not statistically significant.

Oxigene has been up front about the regulatory shortcomings of the "FACT" study. In March, the FDA told Oxigene that a second phase III study with a survival endpoint would be necessary before Zybrestat could be submitted for approval as a treatment for ATC.

This pretty much diminishes any news value from another update of the old study at next month's ASCO meeting.

The second clinical update at next month's ASCO will come from the phase II "FALCON" study that compares Zybrestat, Roche's Avastin plus chemotherapy against Avastin and chemotherapy in patients with advanced non-small cell lung cancer.

Again, Oxigene has presented data from this study previously. The last update was in November, when Oxigene reported the median time to progression for patients treated with the Zybrestat regimen was 9.5 months compared to 8.8 months for the control arm. The difference was not statistically significant and at less than a month's difference, likely not clinically meaningful.

The "FALCON" study is designed to report out an overall survival analysis, but it's not clear whether that's ready for this year's ASCO meeting.

For those wishing to look up the Zybrestat ASCO abstracts on May 18 when they're posted online, the "FACT" study is abstract No. 5502 while the "FALCON" study is abstract No. 7559.


@kevinmcgreevy tweets, "I know things are bad at $alth, but $mnkd has 2x the market cap now?!? Is it that bad?"

Geesh, when you put it that way, you're absolutely right. Allos Therapeutics (ALTH) is way better off than MannKind (MNKD). Then again, there are few drug or biotech stocks in sorrier shape than MannKind, so are you really damning Allos with faint praise?

Kevin's question riffs off a Twitter debate I had with a few people Tuesday night following the release of Allos' first-quarter results (bad) and the announcement of a deal with Mundipharma for European marketing rights to Folytn, Allos' lymphoma drug (good).

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