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MolBiol

03/27/14 4:02 PM

#7348 RE: Epictetus #7346

What exactly do you think ends up killing you when you have metastatic melanoma? The Direct trial is geared towards people with no other option.

criteria:

Patients with a histological or cytopathological confirmed diagnosis of a locally advanced or metastatic solid tumor malignancy for which standard treatment is no longer effective or does not offer curative or life-prolonging potential per clinician judgment.


I would wager virtually every person in the trial has cancer that has spread either to adjacent areas or to far off regions. The idea that a person with colon cancer has one big tumor is absurd.... What exactly are you going to inject when a kidney or liver or lung is riddled with cancer?
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TheRedBaron888

03/27/14 4:11 PM

#7354 RE: Epictetus #7346

Epictetus, MolBiol is raising a genuine concern that Austin and Long are trying to address. Systemic immune response and immune memory, in pre-clinical trials, are what made DCVax-Direct such a compelling candidate for a Phase I trial, and that would have played a big part in getting MD Anderson onboard.

We'll know only at ASCO.

And btw, MolBiol is not just qualified, but very competent in his area of research. We have all benefitted a lot from his contributions to this Board. Please do look up his contributions here to date and you would see that for yourself.



Some quick thoughts on the presentation today....

I think it's near-certain we'll have an expansion of the trial. But it does come with it's attendant benefits of a lower threshold to cross for the Primary Endpoint.

Hodge, the Compassionate Use/Hospital Exemption part looked straight out of your notes in Post No. 7133 :-)

ASCO abstract being accepted and the "quite encouraged" (twice...with a smile) was nice to see. As was the strong emphasis on efficacy, even though this is a Phase I trial. That is an aggressive stance to take, when the safer route would have been to hide behind safety, dosage etc.

Finally, this might sound woolly, but I did like Linda's body language - while stating the case and while taking on the detractor(s). It was calm, composed, clear and firm. Atleast that's what I felt....