June 26, 2013

$PVCT's PV-10 Data on Locoregional Disease Control in Metastatic Melanoma to Be Presented at European Cancer Congress 2013

Monday, the company issued a PR about its poster presentation at ECCO 2013 calendared for the end of September. These data are key and this presentation is important for several reasons.

The poster should draw the distinction and note the subsequent dramatic difference in outcome between (i) patients in Provectus' MM Phase 2 trial whose total tumor burden was treated and (ii) patients whose burden was partially or not completely treated.

The ability to treat as much of a patient's tumor burden is key to PV-10's success.

Recall the company's poster presentation at AACR. "Advanced melanoma patients, particularly those with stage IV disease, have substantial tumor burden in areas that are often non-accessible... immuno-chemoablation with PV-10 is highly effective when all tumors are accessible for injection, providing rapid reduction of tumor burden and tumor-specific immunity."

This is particularly relevant for Stage III melanoma patients, where there is no evidence of distant metastasis and tumor burden should be highly accessible.

Query what data are shown to make Provectus' case that efficacy outcome is much better when all tumors are treated: objective response rate (elucidation of both complete and partial responses), target lesion response rate, progression free survival ("PFS"), etc.

The poster also should draw attention to the presence and work of a local-regional immunological response, in contrast and addition to the presence and benefit of a systemic one.

This presentation should reinforce the case to the FDA for the beneficial impact of PV-10 on Stage III patients (the target population of the BTD application), for which there is no agreed upon or approved standard of care but rather several available options (see NCCN Clinical Practice Guidelines). I would expect this data already has been transmitted to the FDA as part of Provectus' pursuit of and application for BTD.

I will be interested to see if conference data are provided about durability of response and PFS updates.

Provectus is a sponsor of and will have an exhibitor booth at the 8th World Congress of Melanoma in Hamburg, Germany from July 17-20.

The company's ad is on page 46 of the program.

Provectus PI Dr. John Thompson is speaking about limb perfusion & PV-10 during the Loco regional melanoma treatment session co-chaired by Moffitt's Dr. Vernon Sondak on Friday, July 19.

No comments:

Post a Comment