- 72 patients were treated with either ILI or PV-10 at Australia’s Princess Alexandra Hospital; data were
prospectively recorded; primary outcome was melanoma-specific survival; ILI is historical standard of care at reporting
institution
- Regionally-administered ILI and intratumorally-delivered PV-10 provided comparable long-term survival for
in-transit melanoma patients
KNOXVILLE, TN, Jan. 29, 2019 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that the Journal of
Surgical Oncology (JSO) has published results from an investigator-conceived and led, single-center study of in-transit melanoma
(ITM) patients receiving either regionally-administered isolated limb infusion (ILI) or intratumoral (aka intralesional) PV-10 to
assess and compare the effect of these treatments on survival. The JSO article detailed the work of investigators at the Princess Alexandra Hospital (PAH) in Brisbane, Australia, where ILI represents the
historical standard of care for ITM and PV-10 was used to treat ITM under expanded access. Intratumoral injection of PV-10 can
yield immunogenic cell death in solid tumor cancers and stimulate tumor-specific reactivity in circulating T
cells.1,2,3,4
This article, entitled “Patients with in-transit melanoma metastases have comparable survival outcomes
following isolated limb infusion or intralesional PV-10 - A propensity score
matched, single center study,” may be accessed via the JSO's website at https://onlinelibrary.wiley.com/doi/10.1002/jso.25373.5
Key Results from the JSO Article:
- Baseline and disease characteristics:
- Patients matched for key covariates: age, gender, primary disease site, and Breslow thickness
- ILI: 36 patients; 56% men; median age of 76.5 years (interquartile range 69-83); 100% Stage IIIB/IIIC
- PV-10: 36 patients; 56% men; median age of 74.5 years (65-81); 89% Stage IIIB/IIIC (11% Stage IV)
- Treatment response (patient-level best overall response):
- ILI: 22% complete response and 50% overall response rate
- PV-10: 25% complete response and 83% overall response rate
- Survival outcomes:
- ILI
- progression-free survival (PFS): median of 5.0 months (interquartile range 2.7-10.7)
- disease-free survival (DFS): median of 16.5 months (8.9-48.4)
- overall survival (OS): median of 29.7 months (12.3-88.5)
- melanoma-specific survival (MSS): median of 74.4 months (24.3-NA); 12?, 24?, 36?, and 60?month MSS rates of 85%, 75%,
60%, and 60%, respectively
- PV-10
- PFS: median of 3.9 months (9.6-47.9)
- DFS: median of 14.1 months (4.5-20.9)
- OS: median of 27.1 months (14.3-48.6)
- MSS: median of 36.4 months (16.6-65.3); 12?, 24?, 36?, and 60?month MSS rates of 83%, 70%, 54%, and 36%,
respectively
- Differences in PFS, DFS, and MSS comparing ILI with PV?10 were not statistically significant
Among the authors’ conclusions:
- “Overall these results demonstrate that demographically similar patients with in-transit melanoma metastases treated with ILI
or PV-10 have comparable long-term survival rates,”
- “Propensity score matching is a useful statistical technique for examining relative treatment effects within complex patient
groups, particularly when larger randomized controlled studies are impractical,”
- “A complete response to either treatment was the only independent factor identified that significantly predicted long-term
survival,”
- “These findings suggest that both ILI and PV?10 can be considered as a suitable standard of care,” and
- “These treatments are relevant and likely to remain of value in the near future, particularly for the treatment of
symptomatic or refractory metastases following the discontinuation of systemic therapies due to serious drug-related side-effects
or exhaustion of other systemic options.”
Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, “Despite the advances made by targeted
therapies and checkpoint inhibitors, these comparative survival data highlight the important role that investigational PV-10 may
have for the treatment of advanced melanoma. The Australian investigators place PV-10’s role in the context of relatively more
expensive systemic agents that have substantial toxicity profiles and similar response rates.”
Mr. Rodrigues added, “Furthermore, these comparative survival data substantiate the Company’s historical work in
melanoma and provide more validation of PV-10 in a single-agent setting for a challenging patient population. The key focus of
Provectus’ drug development program now is to demonstrate PV-10 activity in both single-agent and combination therapy settings for
the treatment of both hot and cold tumor types.”
About PV-10
Provectus’ lead investigational oncology drug, PV-10, the first small molecule oncolytic immunotherapy,
can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor
cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers.
About Provectus
Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company leading
the development of a new class of drugs based on halogenated xanthenes, which are chemical small molecules. Information about the
Company’s clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Company's
website at www.provectusbio.com.
References
1. Wachter et al. Functional Imaging of Photosensitizers using Multiphoton Microscopy. Proceedings of
SPIE 4620, 143, 2002.
2. Liu et al. Intralesional rose bengal in melanoma elicits tumor immunity via activation of dendritic cells by
the release of high mobility group box 1. Oncotarget 7, 37893, 2016.
3. Qin et al. Colon cancer cell treatment with rose bengal generates a protective immune response via immunogenic
cell death. Cell Death and Disease 8, e2584, 2017.
4. Liu et al. T cell mediated immunity after combination therapy with intralesional PV-10 and blockade of the
PD-1/PD-L1 pathway in a murine melanoma model. PLoS One 13, e0196033, 2018.
5. The JSO previously published results from a PAH investigator-led, single-center study of patients
with ITM who received intralesional PV-10 under expanded access. This JSO article, entitled “Intralesional PV?10 for the
treatment of in?transit melanoma metastases - Results of a prospective,
non?randomized, single center study,” detailed the experience of PAH
investigators treating 45 patients with almost exclusively Stage III disease from 2008 to 2015. The article may be accessed via the
JSO's website at https://onlinelibrary.wiley.com/doi/10.1002/jso.24921.
FORWARD-LOOKING STATEMENTS: This release contains “forward-looking statements” as
defined under U.S. federal securities laws. These statements reflect management's current knowledge, assumptions, beliefs,
estimates, and expectations and express management's current views of future performance, results, and trends and may be identified
by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,”
“project,” “will,” and other similar terms. Forward-looking statements are subject to a number of risks and uncertainties that
could cause our actual results to materially differ from those described in the forward-looking statements. Readers should not
place undue reliance on forward-looking statements. Such statements are made as of the date hereof, and we undertake no obligation
to update such statements after this date.
Risks and uncertainties that could cause our actual results to materially differ from those described in
forward-looking statements include those discussed in our filings with the Securities and Exchange Commission (including those
described in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2017).
Contact:
Provectus Biopharmaceuticals, Inc.
Tim Scott, Ph.D.
President
Phone: (866) 594-5999
