Introgen Therapeutics, Inc. (fka INGNQ)

[poorgradstudent]

>I just dont see any basis in the public record for believing there is
some conspiracy to hide some insufficient or unsatisfactory
result here.<

Forget outright conspiracies.

So what do we have?

A phase III trial that is measuring survival, 240 patients total in 2 arms. First patient accrued in june of 2000, so 56 months ago. If this trial is not fully enrolled yet (no basis not to believe the company), then they are accruing at an atrocious rate of 4 patients *per month*!!!!

That is either gross negligence on the part of ingn, or they no longer care about the outcome of this study. If it is negligence, then that doesn't bode well. If they no longer care about their phase III trial measuring survival, that's because they have seen the writing on the wall with respect to this trial. Remember that this is an open label trial.

Now, we have Pazdur at the FDA again talking out against accelerated approval using surrogate endpoints.

INGN, despite having the T301 trial measuring survival, is saying that they are looking to file for accelerated approval using surrogate endpoints, and plan to finish the filing by year end 2005.

If this 301 trial was looking good, or ingn was indeed interested in its outcome, why would they file for accelerated approval based on a mixture of phase II trials that use surrogate outcomes? Especially when they know that imcl is poised to file for the same indication but with survival data. Survival data trumps surrogate endpoints (see iressa versus tarceva), so it doesn't appear to be a great move by management to avoid putting its best foot forward (t301 survival results).

Now, even when ingn files based on surrogate markers, the FDA is going to want a randomized study to validate the surrogate endpoints that were measured in the phase II studies. Well, conveniently ingn has the t301 trial looking at survival... so what do you think the fda will say? Show us the t301 data.

My bet is that management knows that the T301 trial has no chance of successfully meeting its primary endpoint on an intent to treat basis. They're leaving that trial open so that they don't really have to do an official analysis of it, and thereby trigger disclosure requirements.

Will the management of an unprofitable biotech ever directly tell you that they're shelving a phase III for their lead compound cause it's not looking good? Rarely, if ever. They're more apt to give out very little information (case in point) and let the memory fade.

So no, i do not have any smoking gun to show you that this trial has failed or that management has given up on it. I never will until the trial results come out. However, all their moves to date (accelerated approval, 56 months patient accrual and counting, generally poor disclosure of clinical trial data) give me as clear a picture as I need.

You can believe me, or call me a quack. Don't matter much to me

However, when this all boils down, i'll be here to face up to my conclusions regarding the t301 trial, whether they be right or wrong.