Provectus Provides Update on Metastatic Uveal Melanoma Clinical Development Program for Investigational Drug PV-10

Thursday March 21, 2019

 

KNOXVILLE, TN, /GLOBE NEWSWIRE/ -- Provectus (OTCQB: PVCT) today provided updates on the Company's metastatic uveal melanoma drug development program for its lead investigational cancer agent PV-10. Intratumoral injection of small molecule oncolytic immunotherapy PV-10 can yield immunogenic cell death in solid tumor cancers and stimulate tumor-specific reactivity in circulating T cells1-4, which may lead to a functional recruitment of the immune system.

Update #1. Presentations about PV-10 treatment of metastatic uveal melanoma will be given by Sapna Patel, MD, Associate Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine of The University of Texas MD Anderson Cancer Center at:

  • The International Society of Ocular Oncology (ISOO) Biennial Conference in Los Angeles, California from March 22-26, entitled "Percutaneous oncolytic rose bengal disodium for metastatic uveal melanoma patients with hepatic metastasis." ISOO is a non-profit corporation with the specific and primary purpose to advance and promote the practice of ocular oncology, and
  • The spring meeting of the Ophthalmic Oncology Group (OOG) in London, England from April 11-13, entitled "A Phase 1 Study of Percutaneous Oncolytic Rose Bengal Disodium (PV10) for Metastatic Uveal Melanoma to the Liver." OOG is an independent scientific group devoted to clinical ophthalmic oncology and related basic-science research.

Update #2. The Company will host a round table involving metastatic uveal melanoma patients at CURE OM's Eyes on a Cure: Patient & Caregiver Symposium in Raleigh, North Carolina from April 5-7. The Community United for Research and Education of Ocular Melanoma (CURE OM) is the Melanoma Research Foundation's initiative to increase awareness, education, and research funding for ocular melanoma, while improving the lives of people affected by this disease.

Ocular melanoma is a general category of melanoma disease affecting the eye and orbit. Its most common form, uveal melanoma, is an intraocular affliction originating in melanocytes in the iris, ciliary body, or choroid. Together with melanomas that form in the conjunctiva, cornea, retina, and orbit, these melanomas constitute ocular melanoma. Approximately half of ocular melanoma patients develop metastatic disease despite successful treatment of their primary tumors. Metastatic disease has historically been, and remains, generally fatal.

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, 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. In February 2019, orphan drug designation status was granted to PV-10 by the U.S. Food and Drug Administration for the treatment of ocular melanoma.

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).

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, 2018).

Contact:

Provectus Biopharmaceuticals, Inc.
Tim Scott, Ph.D.
President
Phone: 866-594-5999

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