Provectus Announces Presentation of Data from Metastatic Uveal Melanoma Cohort of Phase 1 Study of PV-10 in Liver Cancers at SMR 2018 Congress

Wednesday October 24, 2018

- Assessing adverse event and preliminary efficacy profiles of PV-10 as single-agent and in combination with immune checkpoint inhibition for treatment of liver metastases

KNOXVILLE, TN, /GLOBE NEWSWIRE/ -- Provectus (OTCQB: PVCT) today announced that preliminary data from the Company's uveal melanoma expansion cohort of its Phase 1 "basket study" of small molecule oncolytic immunotherapy PV-10 for cancers metastatic to the liver were presented in a trials in progress (TIP) poster presentation by Sapna Patel, MD, Associate Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine of The University of Texas MD Anderson Cancer Center (MDACC), at the 15th International Congress of the Society for Melanoma Research (SMR 2018 Congress), held in Manchester, England from October 24-27, 2018. 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

Provectus' ongoing, multi-center, open-label, Phase 1 basket study is evaluating the safety, tolerability, and preliminary efficacy of PV-10 in patients with solid tumors metastatic to the liver (NCT00986661). A single percutaneous injection of PV-10 is administered to a designated hepatic tumor. Response assessments are performed at Day 28, and then every three months. Patients with multiple injectable tumors may receive additional PV-10 after Day 28. At MDACC, this study is enrolling patients into a single-center cohort of up to 10 uveal melanoma patients with hepatic metastases. Eligible patients may also receive standard of care immune checkpoint inhibition during and after treatment with PV-10.

Highlights from the Presentation at SMR:

  • A total of four patients received PV-10 to at least one uveal melanoma liver tumor; two patients received a second round of PV-10 treatment to an additional liver tumor; one patient initiated standard of care immunotherapy (Opdivo® + Yervoy®) between PV-10 treatments.
  • Treatment-related adverse events were consistent with established patterns.
  • Tumor reduction was observed in 5 of 6 PV-10-injected tumors.

The Company currently plans to present comprehensive clinical data at a medical conference in the first half of 2019.

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, "While tremendous progress has been made during this decade to treat cutaneous melanoma, uveal melanoma patients have failed to benefit as much from medical breakthroughs such as immune checkpoint inhibition. The value of checkpoint inhibitors in uveal melanoma as either single-agents or combination therapies has been shown to be extremely limited thus far, including results from several important studies reported this week at the annual meetings of the European Society for Medical Oncology and the Society for Melanoma Research."

Mr. Rodrigues added, "These initial data appear to affirm PV-10’s single-agent activity in yet another tumor type, and point to an important opportunity for PV-10 to enhance the use of checkpoint inhibition for the treatment of poorly immunogenic types of cancer, such as uveal melanoma and neuroendocrine tumors. Assessing the direct and systemic effects of single-agent PV-10 on neuroendocrine tumor liver metastases was the subject of a poster presentation earlier this week at the European Society for Medical Oncology Congress."

A copy of the poster presentation is currently available on Provectus' website at https://www.provectusbio.com/media/docs/publications/SMR2018_PV-10_LC_01_Patel.pdf.

About Metastatic Uveal Melanoma

Uveal melanoma is a rare disease that is biologically and clinically distinct from cutaneous melanoma.5,6 Nearly 50% of uveal melanoma patients develop metastatic disease, with 80-90% of them presenting with liver as the first site of disease involvement.5,6,7 Outcomes of metastatic uveal melanoma are poor, with a median overall survival of 12 months.8

About PV-10

Provectus' lead investigational oncology drug product, 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. Carvajal et al. Metastatic disease from uveal melanoma: treatment options and future prospects. The British Journal of Ophthalmology. 2017;101(1):38-44.
  6. Yang et al. Treatment of uveal melanoma: where are we now? Therapeutic Advances in Medical Oncology. 2018;10.
  7. Afzal et al. Metastatic uveal melanoma showing durable response to anti-CTLA-4 and anti-PD-1 combination therapy after experiencing progression on anti-PD-1 therapy alone. Journal for ImmunoTherapy of Cancer. 2018;6(1):13.
  8. Piperno-Neumann et al. Long-term survival in metastatic uveal melanoma (MUM). Journal of Clinical Oncology. 2018:36 (suppl; abstr e21501).

Trademark

OPDIVO® and YERVOY® are registered trademarks of Bristol-Myers Squibb, New York, New York, U.S.A.

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," "would," "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

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