Provectus
issued a press release today and
made an associated 8-K filing (that included another item) regarding Moffitt Cancer Center's Dr. Vernon Sondak, MD's presentation in Munich, Germany,
Provectus Biopharmaceuticals' Data on PV-10 as Treatment for Melanoma Presented at 5th European Post-Chicago Melanoma / Skin Cancer Meeting. The company made Dr. Sondak's presentation available;
the link is here.
I believe the key takeaway comes from the 19th slide in the deck, which clearly and simply states [what I think is] the ultimate goal of Moffitt's research work on PV-10: to prove or disprove
the hypothesis that intralesional PV10 induces systemic immunity in humans [for melanoma].
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| Click to enlarge. Slide no. 19. New 2015 slide (v. 2014) |
The other slide of note [to me], and that I was struck by, was the presentation's final slide (of "The Moffitt PV-10 Team").
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| Click to enlarge. Slide no. 21. New 2015 slide (v. 2014) |
Below I compare Sondak's 2014 presentation to his 2015 one, which in the early going are ostensibly the same. A shareholder who attended last year's presentation sent me pictures of it.
Disclosures
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| Click to enlarge. 2014 |
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| Click to enlarge. 2015: Slide no. 2 |
Potential Applications
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| Click to enlarge. 2014 |
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| Click to enlarge. 2014 |
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| Click to enlarge. 2015: Slide no. 3 |
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| Click to enlarge. 2015: Slide no. 4 |
Properties of the Ideal Agent
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| Click to enlarge. 2014 |
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| Click to enlarge. 2015: Slide no. 5 |
New in 2015: Sondak included a "history of" slide, which speaks to Rose Bengal lying around in plain sight of Big Pharma for about 75 years before Provectus' cofounders "re-discovered" it, and the drug substance/drug product's safety and specificity (i.e., Pharmacology).
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| Click to enlarge. 2015: Slide no. 6 |
Properties of PV-10
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| Click to enlarge. 2014 |
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| Click to enlarge. 2014 |
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| Click to enlarge. 2015: Slide no. 7 |
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| Click to enlarge. 2015: Slide no. 8 |
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| Click to enlarge. 2015: Slide no. 9 |
New in 2015: A picture of
Melanoma Institute Australia and
the University of Sydney's Dr./Prof. John Thompson, MD with PV-10 (Rose Bengal) on his face?
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| Click to enlarge. 2015: Slide no. 10 |
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| Click to enlarge. 2014 |
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| Click to enlarge. 2014 |
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| Click to enlarge. 2014 |
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| Click to enlarge. 2014 |
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| Click to enlarge. 2015: Slide no. 12 |
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| Click to enlarge. 2015: Slide no. 13 |
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| Click to enlarge. 2015: Slide no. 11 |
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| Click to enlarge. 2015: Slide no. 14 |
New in 2015: Summary/overview slides of Moffitt's work to assess systemic immunity from intralesional therapy, in mice and humans (noting whether and where such work was or was not published in a peer-reviewed journal).
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| Click to enlarge. 2015: Slide no. 15 |
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| Click to enlarge. 2015: Slide no. 16 |
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| Click to enlarge. 2015: Slide no. 17 |
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| Click to enlarge. 2015: Slide no. 18 |
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| Click to enlarge. 2015: Slide no. 19. Notable, as discussed above |
Conclusions
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| Click to enlarge. 2014 |
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| Click to enlarge. 2015: Slide no. 20 |
Final Slide
Sondak's final June 2014 presentation slide was telling, given the FDA's May 2014 denial of Provectus' application for breakthrough therapy designation for PV-10 (in locally advanced cutaneous melanoma), and that he made that presentation well before the Agency's April 2015's advisory committees overwhelming vote in favor of Amgen's talimogene laherparepvec ("T-Vec") having an overall favorable benefit-risk profile for the treatment of injectable regionally or distantly metastatic melanoma (for the latter, see blog post
The first guy through the wall).
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| Click to enlarge. 2014 |
In June 2015, however, there are smiling faces:
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| Click to enlarge. 2015: Slide no. 21 |
Recall Eric said on
Provectus' May 7th 1Q15 conference call:
"We really can't speculate on the direct implications of the T-VEC decision other than to say that clearly the regulatory environment is continuing to change what the agency identified deficiencies in the T-VEC package. And this may come as significant review questions when the agency finalizes the review of potential decision to approve or not approve the BLA, the application for approval for that my logic may have relevance for us going forward. That being said, the end points that were used for the T-VEC pivotal study were different than the ones that we used in Phase 2 study. And more importantly, the T-VEC Phase 3 study, pivotal study was larger, so have more patients than we have in the Phase 2 study. I would speculate that we can see that what was clearly very strong headwinds a year ago are maybe abating here in Washington and that presumably bodes well for future success with PV-10." {Underlined emphasis is mine}
N.B. Provectus did not make Dr. Sondak's 2014 presentation at the 4th European Post-Chicago Melanoma / Skin Cancer Meeting available last year. For whatever reason (e.g., perhaps Eric is more comfortable and confident now than he was then*), Provectus' Chief Technology Officer Dr. Eric Wachter, PhD appears to have allowed the company's Chief Operating Officer/Chief Financial Officer Peter Culepper to press release the 2015 presentation.
* If true and in the absence of more explanation directly from him on this, then my reaction is that such feeling(s) is(are) are disrespectful to Provectus shareholders and representative of an intellectually inconsistent sub-process.
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