Some believe Provectus has the most unusual opportunity in the history of drug development thus far, and that no one has ever seen a drug work like Rose Bengal in PV-10 and PH-10.
[Emphasis below all mine.]
The Cancer Watch article establishes context with historical PV-10 clinical trial success: Back in October, 2012, Phase 2 metastatic melanoma data on use of intralesional PV-10 presented at ESMO (European Society for Medical Oncol- ogy) 2012 Congress in Vienna, Austria, showed an objective response rate (ORR) of 51%, and a disease control rate of 69% in target melanoma lesions. The other finding, which lies behind some of the intensifying interest in PV-10, was a 61% ORR in bystander (uninjected) lesions among patients who had complete or partial responses in their target lesions. The bystander lesion ORR in patients with non responsive target lesions was 18%. Of deep interest, as well, were case studies showing potential stasis or regression of untreated visceral lesions in patients following PV-10 treatment of their cutaneous lesions.
The author further establishes governing thought: A bystander effect was clearly apparent in the first study in that PV-10-treated mice had 3 or fewer lung metastases as compared with more than 250 in each of the untreated mice.
In further elucidating the work at the cancer center, the author wrote: The focus at Moffitt, Dr. Sarnaik continued, is on discerning the presence of immune cell infiltrate in untreated tumors after PV-10 injections into other lesions. "We are really interested in harnessing immune cell infiltrate as a form of treatment," he said, noting also that while creating cancer vaccines has been thought of traditionally as one of the Holy Grails of cancer research, cancer vaccines have turned out to be not strong enough to generate an adequate immune response. Is Dr. Sarnaik implying PV-10 is the Holy Grail?
In response to the weakness of cancer vaccines: The strategy of adoptive cell transfer potentially overcomes the weak vaccine response...While adoptive cell transfer offers the advantage that enough T cells can be obtained for infusion in all patients, the T-cell receptors transfected into the T cells have a limited antigen specificity.
PV-10, however: ...Shari Pilon-Thomas, PhD, also a Moffitt researcher, demonstrated that T-lymphocytes recovered from mice treated with PV-10 do appear to be of a higher quality, as evidenced by stronger tumor reactivity...
Sarnaik's study will test Pilon-Thomas' conclusions in humans: "This is a straightforward study that will give a yes or no answer," Dr. Sarnaik said.
The Cancer Watch article about Moffitt may be the information/PR prelude to the cancer center's long-awaited high profile conference presentation and contemporaneous publication of its work on the immunological MOA characterization of PV-10 work.
When I think of appropriate "high profile" conferences, two come to mind: the annual meetings of the American Association for Cancer Research ("AACR") and the American Society of Clinical Oncology ("ASCO"). The former runs April 6-10, while the latter runs May 31-June 4. While research is presented at both conferences, ASCO is more focused on clinical trial results and updates. As such, and since Moffitt's work to date (excluding the recently initiated human trial) has been murine research, I'd guess the target conference for Moffitt is AACR. If AACR is indeed where Moffitt presents, then I'd also guess the target peer-reviewed publication is Cancer Research.
King Arthur: Go and tell your master that we have been charged by God with a sacred quest. If he will give us food and shelter for the night, he can join us in our quest for the Holy Grail. French Soldier: Well, I'll ask him, but I don't think he will be very keen. Uh, he's already got one, you see. King Arthur: What? Sir Galahad: He said they've already got one! King Arthur: Are you sure he's got one? French Soldier: Oh yes, it's very nice!
Google {"holy grail" cancer} and you get a long list of stuff. Like with many phrases, the "Holy Grail of [insert of what here]" often (usually, always) is far from the Grail itself. The phrase is ill-used, misused and overused.
What is the Grail? A dish, plate, stone, or cup used by Jesus Christ during The Last Supper and, possibly, later used by Joseph of Arimathea to collect Jesus' blood upon his removal from the cross upon which he had hung. Grail literature divides into two classes. The first concerns King Arthur’s knights visiting the Grail castle or questing after the object; the second concerns the Grail’s history in the time of Joseph of Arimathea. I sourced and copied most of this from the Holy Grail's Wikipedia entry.
The Holy Grail For Cancer (November 10, 2010) -- The “Holy Grail” for bone cancer treatment could be in the form of bacteria modified to kill cancerous cells
Proteomics is the Holy Grail for Cancer (March 14, 2011) -- Proteomics give us the ability to build a causative model of why the body is not dealing with the cancering like it normally does.
The treatment that is holy grail for cancer is very effective and very safe. Since there was only one grail, cancer's holy grail also is viable for for multiple indications. Many of the illustrative stories and links above suggest their respective grail targets only diseased, cancerous tissue, and avoids or leaves untouched normal or healthy tissue.
Fareed Zakaria, in a December 10, 2012 interview on Fareed Zakaria GPS of Dr. Ronald DePinho, M.D., President of MD Anderson's cancer center, said "The holy grail for cancer would be to trigger the body’s own immune system to fight off the cancer, so that you somehow stimulate the antibodies in a way that that happens." The treatment that is the holy grail for cancer is not the grail itself. Rather, the grail is what the treatment inspires, produces, engenders, induces, etc.: a strong, durable, portable immune-mediated response.
Is the Grail priceless in material terms? Think about the scene from Indiana Jones and the Last Crusade, and Walter Donovan, the wealthy American industrialist and collector of antiquities who allied himself with the Nazis in order to get the Holy Grail.
Just like Indy's not-so-poor choice of nondescript chalice, the treatment that is holy grail for cancer is inexpensive to make and produce.
Knights over decades and centuries have sought their own holy grail. The climax of the quests, it would seem, is when the protagonists ask, among other questions: "“What validates the quest?” Why am I doing this?"
"Inwards. Into the heart of yourself. This is the third degree of Knighthood. It is known as Contemplation. This does not mean retreat from the world...rather that in undertaking his worldly adventures he encounters them also inwardly. “Who am I?’ he will enquire of himself, ‘this man who goes about righting wrongs?” Echo alone will make reply....So it is with the dragons, the ill-famed knights, the distressed damsels, the fiends. They have their reflections in the inner selves that need to be struggled with, exorcised, and, indeed, accepted. The quest from the very beginning has had as its aim the knight’s self-transformation. Only one made new by grace or made anew by his own efforts will find what he has sworn to find, a glimpse of the Sangreál."
Ultimately, the grail is just a story of a journey. Perhaps in this case, the journey is the journeys of many different individuals and constituents (principals, a No. 4, shareholders, etc.) within the fabric of one journey itself: Provectus Pharmaceuticals.
What the hero’s tale – echoed in countless cultures – may most powerfully suggest is that we all stand at the threshold, having heard the call. Still reluctant, we know at the deepest level that the journey beckons and that we must set out. (Jim Kenney, The Hero's Quest & the Holy Grail)
