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."
- 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.
- 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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