May 12, 2014

Judgement Day(s)

Provectus will be judged in three key and critical ways between now and early-June.

1. Credibility, via the up-listing of the stock (this week?)

In no small part, Provectus and management's credibility is diminished because of their presence on a minor stock exchange. Other decisions certainly have hurt. Should/when the company up-list onto the NYSE MKT (or NASDAQ, although I think the prevailing belief is the company will seek to list on the former), this may change if/when there is greater institutional interest to buy Provectus shares (and if/when the share price rises much more from where it closed today).

Least among the questions of their credibility, in my view, however, is where management hailed (i.e, their professional background); that is, common to all of the founding principals, Oak Ridge National Laboratory. Given a prior life in the defense and aerospace industry, familiar with organizations like the National LabsDARPA, GOCOs (government owned/contractor operated) like NCI, etc., I value this background and their achievements and accomplishments there, in context of course, equivalent to and/or more than folks from, for example, Moffitt Cancer Center, Rockefeller University, M.D. Anderson or Pfizer. Good technology is seductive. Great technology like PV-10 is intoxicating.

You can read about 50 breakthroughs innovated by America's national labs here (a 2011 publication).

2. Local response, via receipt of breakthrough therapy designation (by May 23rd?)

Intralesional delivery of cancer agents and thus intralesional oncology compounds like PV-10 (and Amgen's marginal T-Vec and Vical's failed Allovectin-7) have long been questioned. How can a local agent treat a systemic disease?

There is growing evidence local delivery, rather than systemic, better leverages the cancerous tumor microenvironment. The tumor microenvironment matters because of heterogeneity within it, and the opportunity for robust, diverse antigen expression or presentation to more effectively harness the immune system. The granting of breakthrough therapy designation to PV-10 for locally advanced cutaneous melanoma (i.e., recurrent, in-transit or satellite melanoma that has not yet spread from the skin to distant sites) should go a very long way in changing the perception and reality of how cancer is and should be treated.

3. Systemic response, via awareness and embracing of ASCO abstracts & posters (May 14th, June 2nd, other?)

No small molecule without some modification or augmentation has been able to deliver anything close to the kind of immunologic response PV-10 has shown to do. How can Provectus claim a robust bystander effect?

Moffitt has of course begun to elucidate the multi-step mechanisms of action of PV-10, recently noting from their first clinical study that "...clinical data on 8 melanoma patients...demonstrated significant decreases in melanoma cells in injected tumors and uninjected bystander tumors 7-14 days after PV-10 injection...," and "[i]ronically, the original aim of the trial to assess tumor-infiltrating lymphocytes was thwarted when biopsies of patient tumors collected just 7-14 days after PV-10 injection no longer contained viable tumor tissue." ASCO 2014 potentially provides more glimpses into their work on PV-10 as a monotherapy and, maybe, in combination with checkpoint inhibitors.

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