Introgen's Data-Mining Misleads

Patients with an "abnormal p53 marker" who live longer taking Advexin sounds a lot like lung cancer patients who are left-handed, doesn't it?

It's a nice retrospective observation, but it's hardly a conclusion, and therefore it won't carry weight with the FDA. Back in 2004, Allos Therapeutics(ALTH Quote) tried the same thing with its cancer drug but came back from the FDA rejected.

What's worse for Introgen -- even more so than my made-up left-handed lung cancer scenario -- is that the data-mined Advexin subgroup totals all of 16 patients out of the 217 patients in its phase II study. That's a bit of important information that Introgen chooses not to disseminate widely but will cop to when asked privately. (I did exactly that last summer during a meeting with Robert Sobol, the company's chief science officer, at an investment conference in Boston.)

Sobol also admitted that so-called p53 biomarker survival analysis was found retrospectively, and that patients in the phase II study were not routinely screened for p53 levels before or during the trial.

As I said in Saturday's column, this all adds up to a lot of bamboozlement on Introgen's part. Now, you might ask why a company would go to the FDA with drug data it knows has zero chance of approval. It's simple: Introgen has no other choice and not much to lose.