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Titan Pharmaceuticals Inc. Message Board

  • terryhallinan terryhallinan Aug 9, 2002 10:58 AM Flag

    DNDN is up on news of failed trial


    >>The trial (D9901) involved 127 men with late stage, metastatic, hormone resistant prostate cancer, 82 of whom received Provenge. Patients were randomized to receive three vaccinations of Provenge or placebo over a four-week period. The primary endpoint for the study was the time to objective disease progression. Comparison of the Provenge treated group to the placebo group using the Kaplan-Meier method revealed a clinical benefit in the Provenge treated patients (p-value = 0.085)<<

    Not as bad as headlines, eh?

    Won't cut it with the FDA but notice the numbers in the trial and that the endpoint was TTDP (time to disease progression).

    Best, Terry

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    • Terry;

      "failed" is a bit strong here. The subpop turns out to be 75% of the typical hormone-blockade refractory population.

      The study was unfortunately biased toward higher-Gleason scored patients - as might be nievely suspected. But, now we know better.

      This begs a bigger question. Early treatment is better than late. And perhaps even the radical idea of using a vaccine for prevention.

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