June 29, 2012

Metastatic Melanoma: A Murine Study Confirming an Immune Response with PV-10

Via Provectus News, yesterday, the company circulated an article appearing in the June 2012 edition of Cancer Watch highlighting Moffitt's first two studies that confirmed PV-10's direct effect and systemic response.

It is a good and very important read, and sets the stage for the potential release of Moffitt's subsequent work possibly later this year.

More than reading a review of outcome of Moffitt's initial work, I was struck by several items in the article:
  • In addition to Moffitt's Dr. Toomey, who led the immunology-related work, meaningful, substantive and positive quotes by several key opinion leaders (KOLs):
    • Dr. Merrick Ross, Professor of Surgery at MD Anderson Cancer Center (Texas),
    • Dr. Robert Andtbacka, Assistant Professor of Surgical Oncology, University of Utah School of Medicine, and Huntsman Cancer Institute (Utah),
    • Dr. Donald Morton, Chief of the Melanoma Program at John Wayne Cancer Institute (California),
    • Dr. Amod Sarnaik, Assistant Professor of Cutaneous Oncology at Moffitt (Florida); and,
    • Dr. Vernon Sondak, Professor of Surgery, Chief of Cutaneous Oncology and Director of Surgical Education at Moffitt (Florida).
  • A cogent and unequivocal summation by Dr. Andtbacka of Dr. Toomey's findings of higher concentrations or amounts of interferon-γ: "Interferon-γ is thought to be the quintessential cytokine mediating an immune response to melanoma. The fact that restimulating splenocytes with the tumor produced a lot more interferon-γ is very promising."
  • Supportive comments, in context, by key KOL Dr. Morton, who is widely recognized as a pioneer of surgical oncology research in general, of vaccine therapy for melanoma and of intralesional therapy: "While Dr. Toomey’s research needs to be confirmed on a much larger scale, the findings are interesting and promising."
  • Dr. Sarnaik's striking comments that a PV-10-induced antigen response is more like a surgical strike with clear patient benefits that accrue thereof: "The PV-10-induced antigen response is more like a “surgical strike” in that only a subpopulation of cells is targeted for destruction, and immune cells that remodel or repair an immune reaction are recruited."
  • Dr. Toomey's comments on the importance of the systemic effect at cancer's unseen level, because of the likely existence of microscopic levels of metastases that cannot be visualized and treated directly: "The hope is that if you have a lasting immune response, you’ll end up with longer disease-free survival and overall survival."
  • The opportunity, now, to experiment on how PV-10 might further increase efficacy through further stimulating the immune system by combining the drug with a host of other therapies.
  • Dr. Sondak's closing comment: "There is no question that there is a  clinical need for this sort of treatment."
The questions posed by the article's author have already clear answers:
  • Does the PV-10-induced immune response last? More than likely yes, given the statements by Dr. Agarwala in Munich that PV-10 has a durable response. Of course, the durability of the immune response has not yet been commented on by Moffitt.
  • Are multiple injections useful? Yes, as demonstrated in the compassionate use program.
  • Why do some patients respond to PV-10 and others not? More than likely due to improper or ineffective injections.
  • Would re-treatment help non-responders? Yes, as demonstrated in the compassionate use program. Use enough water to douse a fire, and you put it out. Use enough PV-10, and cancer goes away.
  • Would pre-neoadjuvant use (prior to surgery) be beneficial? Yes. The lack of disfiguring results with PV-10 should mean surgery need not be the first thought in a physcian's treatment decision tree. For example, imagine a world where women need not suffer the indignity of a mastectomy. Ever.
  • Front-line therapy? Yes.
This is just the beginning, or the tip of the iceberg, of the revelation of Moffitt's work. What more can we expect? How spectacular could the results of their further work be?
  • Has Moffitt conducted studies on other cancer indications to validate (confirm) PV-10's multi-indication viability?
  • Have they validated (confirmed) the durability of PV-10's immune response?
  • Has Moffitt combined PV-10 with other therapies, such as ipilimumab (Yervoy)?

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