June 19, 2013

$PVCT & $PFE's Hisun-Pfizer Pharmaceuticals Co., Ltd.

In my blog post "I think the situation with $PFE and $PVCT has escalated," I wrote the injection of PV-10 and its subsequent chemoablative action creates lots of antigens. The creation of lots of antigens is the key to the successful, sustainable treatment of cancer and, thus, its cure. Antigen presentation is a process in the body's immune system by which macrophages, dendritic cells and other cell types capture antigens and then enable their recognition by T-cells. PV-10 creates an "antigen storm," the creation of many antigens, much more than than any other antigen-creating material currently available. One would think Dr. Eagle is well are of this.

In the context of Provectus' white paper describing PV-10's systemic immuno-stimulatory effects, it is interesting to read Dr. Eagle's comments about stimulating the immune system and doing so to in a specific way. What follows is a transcript of a Generex conference call from October 2010, where Dr. Eagle had sat on this company's scientific advisory board ("SAB"). Interestingly, in November 2010, Dr. Eagle visited with and viewed Provectus's presentation of its preliminary MM Phase 2 results at an Australian conference.

Bold emphasis below is mine. The "Eric" below refers to/is Dr. Eric Von Hofe, President of Antigen Express, Generex's wholly owned subsidiary (and not Provectus' Dr. Eric Wachter).
Thanks Eric. For the people on the phone, my name is Craig Eagle, and I’m an MD by training in Australia, and I’ve been working with Generex for the last six to nine months as part of its Scientific Advisory Board, and really what I want to do and discuss today was two very high-level concepts particularly around Antigen Express and the immune portfolio.  And the first is around the science. We all every day depend upon the immune system to protect us from diseases whether it be cancer or infections. And we know, and certainly many companies in the field of cancer technology are looking at ways to augment the immune system to attack cancer. One of the things that Antigen Express is working on is looking at it from two angles. One is to stimulate the immune system in itself, that’s (two key) protein, and the other is to (inaudible) direct and stimulate the immune system to a specific target. Now the beauty of this approach and the reason that I think there’s a lot of potential research required here to prove whether these compounds achieve treatment in cancer centers around the fact that, as Eric mentioned, the platform. 
In particular the platform of stimulating the immune system and directing it is a platform that has been recommended in the scientific world of (immuno-) oncology, and at the moment, the forerunner is looking at HERC2 breast cancer. Now the beauty of looking at HERC2 breast cancer as the forerunner is that Antigen Express, I believe, has designed the right experiments to test whether the vaccine works, but also HERC2 expression breast cancer is an area that has already shown and been well defined to have benefit from treatment, in particular, people may be familiar with a product called Herceptin, and Herceptin was a breakthrough for treating patients with that particular cancer.
And so the vaccine will then add and be able to augment potentially the immune system in a (robified) cancer population that still needs further treatment.  Also, what makes it exciting from the Antigen Express point of view, in my view, is related to the fact that they can build on that cancer immunology to then branch out to other cancers where there could be positive results.  In particular, the signs would suggest that the HERC2 expression, just like Herceptin, has been used in other cancers, could be explored with further research on its benefit there.

Finally I just want to move along to other areas, and Eric mentioned those, and that is the immune system could be used in (antigen effectives (ph) or as an immune modulator for areas like diabetes.  So now when you look across multiple and different biotech companies, and certainly from a research point of view, there are probably three criteria that are key to remember. The first is that, as Eric mentioned, in the Antigen Express space there’s a platform. A platform to stimulate the immune system to achieve what it needs to achieve to control cancer, infections and other diseases, and it’s just a case of producing, testing and doing the right research to develop those products forward.  The second area, then, is to do the right experiments and the right testing, and Eric and the team at Antigen Express have been working very hard to make sure that the trials that they are doing are trials that we (to the) right questions from a scientific point of view.

So the quality of the trials has to be paramount and above all very important to show whether the (products) worth or not.  And finally the third area is actually an overall direction for the potential treatment of patients in a (robified) population.  So I’ve already mentioned that HERC2 breast cancer is well defined and there is a very significant unmet medical need with women with cancer of the breast who get their cancer progressing despite the best standard of care, and so there’s certainly potential here to actually save lives and help women with breast cancer.  So all in all I think that Antigen Express creates a great, stable platform to actually explore and research these compounds moving forward.  I’ll hand over now to Gerry Bernstein who can then further discuss the metabolic aspects of Generex. Gerry?
Dr. Eagle's interest in or perspective of stimulating the immune system with great specificity seems very consistent with Provectus' path to immuno-oncology.

As an aside, in checking Generex's SAB website page and the SAB website page of it's subsidiary Antigen Express for links to use in this post, it would appear Dr. Eagle is not mentioned on either site's SAB pages anymore. I believe he still is a director on the boards of Regenicin and Assured Pharmacy.

Pfizer announced the signing of a memorandum of understanding ("MOU") with Hisun Pharmaceuticals in June 2011 to establish their joint venture ("JV"), Hisun-Pfizer Pharmaceuticals, which no doubt took many months to construct before signing. The JV was contributed to/funded in September 2012, nearly 15 months later.

Recent articles about Hisun-Pfizer suggest a very independent company from Pfizer. The economics of the JV are notable for Pfizer, which owns 49% of it versus Hisun's 51% controlling stake. Kevin Xiao is CEO of Hisun-Pfizer, with whom Peter interacted this week.

Whether a deal gets done with Hisun-Pfizer for China more than likely is up to the Chinese, and not exclusively Pfizer, who I think are encouraging a transaction for this geography between the JV and Provectus parties. I think that because I think, after Peter and Eric's recent trip to New York and various meetings with Pfizer there, Dr. Eagle has more recently taken a more active role in his interactions with Provectus (although I'm sure he's been a contributing SAB member since he joined).

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