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Biotech / Medical : Provectus Pharmaceuticals Inc.
PVCT 0.06500.0%Nov 14 9:30 AM EST
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To: dirkdiggler who wrote (12221)7/13/2013 10:35:37 AM
From: NTTG1 Recommendation

Recommended By
Pogeu Mahone

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Analysis of the PIII dataset available in the public domain demonstrated significantly lower response rates in aggressive (node positive) stage III and stage IV patients. It is likely that during discussions with the FDA, PVCT did not have sufficient supportive evidence for putting these patients at risk in a PIII trial.


It is currently unclear whether the limitation imposed on PVCT is an inherent problem with IL administered therapies or more specific to PV-10 dosing or MOA, but the companies push for injecting 'all visible lesion sites' is a reflection of their dose-effectiveness concern in a head to head trial with PFS as an endpoint.

It will be interesting to look at data from the Vical PIII trial, due for top line release later this year, to see how their stage III and IV patients responded to IL vaccine based therapy. If they encounter lower responses in stage IV then there may be an overall problem with IL based vaccine therapy in these more aggressive cancers. Interestingly, their protocol does not restrict patient enrollment for node status, but does exclude patients with lesions in the brain and liver, but not lung. (recent PVCT interest in mouse models with concomitant skin and lung lesions may be an attempt to try and include stage III with lung lesions in their PIII design, after initial FDA discussions)

The proposed study for PV-10 will apparently be restricted to stage III b and c stage patients (If you are interested in the details of staging, see table 4 from the link below; but you will also have to review tables 1-3 to get a feel for T/N/M categories). Protocol will apparently require that all active nodes in stage III patients be removed prior to enrollment (?), it will be curious to see what the time interval between removal and enrollment will be.

Hope that is helpful

cancer.gov
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