January 24, 2013

$PVCT: Provectus to Present Data on PV-10 at the American Association for Cancer Research Annual Meeting in April 2013

Provectus issued a PR yesterday announcing the acceptance of Craig et al.'s poster presentation -- Combination of PV-10 immuno-chemoablation and systemic anti-CTLA-4 antibody therapy in murine models of melanoma -- at the American Association for Cancer Research (AACR) Annual Meeting in April 2013 in Washington, D.C.

Management checked with AACR to see what they could and could not say about the abstract and work in the PR. Provectus, at this point, is allowed to say (i) the abstract is accepted and (ii) the title. They cannot release data until the embargo is lifted, which will be in stages and does not start until sometime in March.

As Craig mentioned during his presentation at the Noble Financial Capital Markets Ninth Annual Equity Conference (click the preceding link to view it) around about minute 14:00, there is very significant interest to see how PV-10 works with systemic treatments (e.g., chemotherapy, immunotherapy, etc.), because it has become clear these secondary treatments work better after an initial use or application of PV-10.

You may recall from my post Provectus Pharmaceuticals Announces H. Lee Moffitt Cancer Center Initiates Phase 1 Study of PV-10 to Elucidate Bystander Effect the notion of PV-10 making cancer treatment more effective in combination with other therapies also is important (very, actually); particularly for late stage patients (a group not targeted by Provectus' current registration pathway for PV-10, which is to facilitate the treatment of Stage III and early-Stage IV patients) and those with heavy tumor burden.

Craig et al.'s work announced today -- the combination of PV-10 and systemic anti-CTLA-4 antibody therapy -- clearly targets and is in response to serious interest from Big Pharma: Bristol-Myers Squibb & ipilimumab/Yervoy and Pfizer/MedImmune-AstraZeneca & tremelimumab (MedImmune in-licensed tremi from Pfizer in 2011 for global development rights to the drug while Pfizer retained rights to specified types of combination therapies).

PV-10 + systemic chemotherapy: Craig etl al.'s murine work -- Generation of an antitumor response and immunity using a small molecule drug (PV-10) -- at the Society for Immunotherapy of Cancer (SITC) 27th Annual Meeting on October 26 and 27, 2012 in North Bethesda, Maryland explored time to progression and tumor growth from PV-10 alone, 2 cycles of 5-FU, PV-10 and 2 cycles of 5-FU, and a saline control. Provectus concluded co-administration of PV-10 immuno-chemoablation with other systemic therapy, in this case, 5-FU, can yield potent synergy in uninjected tumors (Combination of PV-10 with systemic chemotherapy can yield synergistic beneļ¬t in untreated tumors supportive of ongoing clinical work; f/n: A study to assess PV-10 chemoablation of cancer of the liver; clinical trial NCT00986661). PV-10 did not interfere with the systemic chemotherapy agent, nor did it create or cause a toxic reaction. In fact, by boosting the immune system, PV-10 allowed the chemo agent to perform better.

PV-10 + radiotherapy: Foote et al.'s initial and ongoing work combining PV-10 and radiotherapy are showing dramatic improvement for patients with much later stage disease (Stage IV) and heavy tumor burden. At least 10 patients have been treated, a follow-up to the success of their initial work on 3 patients.

PV-10 + systemic immunotherapy: As I wrote earlier, there is very significant interest to see how PV-10 works with ipilimumab (an anti-CTLA-4 agent). Because ipi is human-specific, Craig used a mouse anti-CTLA-4 antibody. Craig et al.'s work is a necessary pre-cursor to human trials (one cannot simply run such experiments without sufficient data to show the FDA how the combination might work and that it is safe). This mouse study will be used to convince regulators that Provectus should be allowed to run a Phase 1 trial combining PV-10 and ipi (as Craig mentioned at the Noble conference).

Click to enlarge figure.
Other combinations: As a treatment PV-10 lies in the "sweet spot" of the addressable market of patients afflicted with melanoma that comprises the vast majority of patients. Patients with very late stage disease and/or very heavy tumor burden, depending on whose numbers you use, probably comprises 2-5%. Nevertheless, as with today's announcement that heralds the successful demonstration of PV-10 and a systemic immunotherapeutic agent (as with the company's SITC-presented earlier work that successfully demonstrated the combination of PV-10 and a systemic chemotherapeutic agent) Provectus is seeking further combinations to make very late stage disease patient treatment options better (e.g., intra-tumoral GM-CSF, systemic interleukin, anti-PD-1 antibodies/agents, etc.).

Today's PR is not related to the anticipated Moffitt immunological MOA characterization work (mouse & human) that will be presented later this year at a high profile conference like AACR. Moffitt presumably will notify Provectus if the cancer center's abstract(s) has (have) been accepted. Then, management will work with Moffitt to coordinate news flow.

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