October 8, 2014

"The few injections needed in this study bode well for patient compliance with PV-10 treatment"

Three articles about Provectus' PV-10 and other investigational drug clinical data presentations from ESMO 2014 were published this week.
  1. Melanoma treatment PV-10 shows promise in phase 2 trial, Dermatology Times online, Bill Gillette, October 6, 
  2. Melanoma studies dominate ESMO, Medical News Today online, Janet Fricker, October 7, and
  3. Intralesional injections show promise for cutaneous melanoma, eCancer News online, Janet Fricker, October 7.
Dermatology Times
“The results of this study provide evidence of a safe and effective intralesional treatment for patients with melanoma metastatic to cutaneous and subcutaneous sites, with a pronounced local and, in addition, systemic effect,” Dr. Agarwala tells Dermatology Times. “It also has the potential to be combined with recently approved systemic immunotherapies that will be the focus of future clinical trials.”
"The progression-free survival of 9.8 months compares favorably with historical progression-free survivals of less than 2.5 months for DTIC/TMZ," said Sanjiv Agarwala, the first author from St. Luke's Hospital and Health Network, Bethlehem, PA. Such data, he added, suggests PV-10 will deliver significant progression-free survival effects in the phase 3 study, due to start Q4 2014. "The abstract also shows us that we're likely to get the highest responses when all lesions are injected." {Underlined emphasis is mine}
eCancer News
“The few injections needed in this study bode well for patient compliance with PV-10-treatment,” said Eric Wachter, Chief Technology Officer of Provectus.
Clinical data from Provectus' metastatic melanoma Phase 2 trial has been presented at six major oncology conferences, most recently ESMO 2014, which is the setting of the above articles:
  • ASCO 2009, Chemoablation of Melanoma with Intralesional Rose Bengal (PV-10),
  • ASCO 2010, Chemoablation of Melanoma with Intralesional Rose Bengal (PV-10),
  • ESMO 2012, Immuno-chemoablation of metastatic melanoma with intralesional rose bengal,
  • ECCO 2013, Locoregional Disease Control in Metastatic Melanoma: Exploratory Analyses From Phase 2 Testing of Intralesional Rose Bengal,
  • ASCO 2014, Efficacy of intralesional rose bengal in patients receiving injection in all existing melanoma in phase II study PV-10-MM-02, and
  • ESMO 2014, Subgroup Efficacy in Patients Receiving Intralesional Rose Bengal to All Existing Melanoma in Phase II Study PV-10-MM-02.
The theme, from the beginning (ASCO 2009) through today (ESMO 2014), has been defeating or controlling the disease [of melanoma] at Stage III to prevent its spread and metastasis to Stage IV by hitting (injecting) all of the disease (all disease burden, or every accessible tumor/lesion).
Click to enlarge. ASCO 2009
Click to enlarge. ESMO 2014
Click to enlarge. ASCO 2009
Click to enlarge. ESMO 2014
Some would say Provectus' mined* its metastatic melanoma Phase 2 clinical trial data, and/or flogged it to death. A simple counter would be that medical conferences could have said no to each subsequent abstract from and data representation from by the company (although that does not absolve Provectus' principals from not have generating different and more clinical trial data to date).

With the understanding overall survival beyond one year was not among the study's data collection goals, the Phase 2 melanoma data eventually presented a clear picture of how to most efficaciously utilize PV-10 in the most advantaged patient population: Treat all disease burden (put another way: treat patients whose only disease is all and entirely accessible).

Rearranging the contents of the ESMO 2014 table above in a different way, with some different labels* of my own...
Click to enlarge.
...yields the graph below:
Click to enlarge.
What projection of results might one reasonably infer for Provectus' pivotal Phase 3 trial for locally advanced unresected cutaneous melanoma when all lesions (all disease burden) are continuously for 12 weeks before initial comprehensive disease assessment?
Click to enlarge.
Eric's quote regarding minimal PV-10 injections facilitating patient compliance is an important aspect of the drug's value proposition in a clinical (outpatient) setting. While easy to administer for the physician (or nurse practitioner), fewer injections (such as, typically, 1 or 2) also should be easier for the patient to accept.

* Mining data in the negative sense: Finding data to fit an already-decided conclusion

** Without total numbers of treated and untreated lesions per grouping, while "All" means 100%, it is hard to quantify "Most," "Some" and "Not enough."

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