i.am.a.pvct.inv...'s  Instablog

Taken From Connecting The Dots...Provectus Pharmaceuticals (March 6, 2013).

Two summary thoughts from today's release of the AACR abstracts, one by Moffitt and one by Provectus, follow.

Moffitt
The first one derives from the second to last sentence of Moffitt's abstract: "In total, these studies support the induction of tumor-specific T cell-mediated immunity after single treatment with IL-PV-10 in multiple histologic subtypes."

"Multiple histologic subtypes," an extremely comprehensive statement, refers to all cancer indications tested by Moffitt: breast, melanoma, ... Tumor specific immunity was achieved in multiple indications.

Chemoablation via PV-10 ablation causes antigenization, and antigenization causes immunization.

Wachter et al.
The second thought comes from the last sentence of the company's abstract: "The rapid reduction in tumor burden and tumor specific immunologic stimulation provided by PV-10 may complement the immune stimulation of anti-CTLA-4 antibodies such as ipilimumab without increased toxicity."

You will recall I wrote earlier:

The crux of the matter is that PV-10, as a local agent, needs to show systemic potential for life science investors, Big Pharma and the FDA to view the drug as clinically relevant. This is the local agent "burden of proof." There must be systemic potential to be relevant for treating cancer after surgery, where cancer is viewed by definition as a systemic disease. PV-10 is an drug with tremendous local efficacy and before unseen systemic benefit (even more so than systemic agents).

But PV-10 still is a local agent.

The mindset of the industry -- medical oncologists and hematologist-oncologists, but not surgeons -- is that a local agent has to be combined with a systemic agent to be relevant. The industry does not yet realize how much of an impact PV-10 will be just as a local agent. All it can currently understand is that PV-10 works, and harnesses the immune system in novel manner. It is obvious to industry PV-10 will get even better systemic results when combined with other agents, or, other agents will get better results when combined with PV-10.

"PV-10 may complement the immune stimulation of anti-CTLA-4 antibodies...without increased toxicity:" Provectus further elucidates the concept of PV-10 orthogonality to systemic therapies; in this case, systemic immunotherapy in the form of anti-CTLA4 agents like Bristol Myers' ipilimumab (Yervoy) in murine model work. Ipilimumab gets better results when combined with PV-10, with no increased toxicity.

Orthogonality: In geometry, two lines (vectors) are orthogonal if they are perpendicular; that is, they form a right angle. Our three dimensions -- the x-, y- and z-axes -- are orthogonal because each is at right angles with the others: non-overlapping, uncorrelated, or independent of each other. In computer science, orthogonality is "a system design property which guarantees that modifying the technical effect produced by a component of a system neither creates nor propagates side effects to other components of the system." (Source: Wikipedia).

Previously, the company demonstrated orthogonality (in pre-clinical work that led up to the upcoming human trial) with systemic chemotherapy agent sorafenib (in the case of liver cancer/HCC). Sorafenib gets better results when combined with PV-10, with no increased toxicity.

Later, Provectus provided results of orthogonality with [inexpensive] systemic chemotherapy agent 5-fluorouracil ("5-FU") in murine model work. 5-FU gets better results when combined with PV-10, with no increased toxicity.

Disclosure: I am long PVCT.OB.

Additional disclosure: I am a large shareholder of Provectus Pharmaceuticals, have not sold any shares as of this Instablog submission, and also author the blog "Connecting the dots...Provectus Pharmaceuticals."

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Disclosure: I am long PVCT.OB.

Additional disclosure: I am a large shareholder of Provectus Pharmaceuticals, have not sold any shares as of this Instablog submission, and also author the blog "Connecting the dots...Provectus Pharmaceuticals."

Taken From Connecting The Dots...Provectus Pharmaceuticals (February 19, 2013).

Peter should be off to China in a week. What may or could happen?

A. He secures a deal.

If Peter gets a deal done, he:

1. Returns with the upfront payment,
2. Signs an memorandum of understanding ("MOU") that at least identifies the Chinese strategic partner by name, or
3. Signs a letter of intent ("LOI") with the partner where key provisions (i.e., terms) would have been agreed to by the partner and Provectus to provide the basis for definitive agreements.

Along branches (2) and (3), definitive agreements could be completed, signed and then enable the company to receive the upfront payment within 30 to 60 days.

B. Peter does not secure the deal because the intermediary Provectus used for China is unable to get the strategic partners to do the contemplated deal.

It appears the process of bringing partners to the table, after blessings have been provided by and an agreement has been reached with the Chinese central government, is not dissimilar to an arranged marriage. Potential brides with dowries of different amounts, composition and strategic value in hand assemble in a "room" -- depending on whether the current agent is able to get them into the room (i.e., get them to agree to the general terms and conditions previously approved by the government) -- for Peter and the team that will travel with him to China, to pick. If no bride has a sufficient dowry, he returns to China with a new agent or intermediary, say in another month or more, to renew his attempt to secure a deal. Management believes China will not turn the company down because of strong interest there to do a deal with Provectus.

C. The Board and management elect to turn down a China deal because of Big Pharma interest to do a much larger global license for PV-10.

Enough said.

What are the probabilities of A, B and C? I do not know, although I do have my opinion. Like you, I will wait to see what PR and SEC filing, if any, are issued and made the week of March 4th, and then ask for explanations if necessary.

I have high expectations for management to get a very good deal done if China, if and should they close such a deal. The market and most observers of Provectus have little to no expectations. Expectations may rise closer to the week of March 4th, but more likely only after a deal has been struck and its details made known. To life sciences investors and investors at large, China and Provectus is the ultimate "Show-Me," as they say in Missouri.

My own expectations are in the table below.

Disclosure: I am long PVCT.OB.

Additional disclosure: I am a large shareholder of Provectus Pharmaceuticals, have not sold any shares as of this Instablog submission, and also author the blog "Connecting the dots...Provectus Pharmaceuticals."