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.
No comments:
Post a Comment