- First cohort of 6 patients enrolled and treated; currently recruiting patients into second cohort
KNOXVILLE, TN, Oct. 23, 2018 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that the Company's
ongoing Phase 1 clinical trial of single agent PV-10 for the treatment of symptomatic neuroendocrine tumors (NETs) metastatic to
the liver was the subject of a trials in progress (TIP) poster presented at the ESMO 2018 Congress (the European Society for
Medical Oncology annual meeting), held in Munich, Germany from October 19-23, 2018. Intralesional injection of PV-10 can yield
immunogenic cell death in solid tumor cancers that results in tumor-specific reactivity in circulating T
cells.1,2,3,4
This single-center Phase 1 study is being conducted at The Queen Elizabeth Hospital in Adelaide, Australia to evaluate the potential safety,
tolerability, and preliminary efficacy of PV-10 in patients with metastatic NETs (mNETs) of the liver (NCT02557321). The primary endpoint for the trial is safety, and secondary endpoints include
objective response rate, target lesion somatostatin receptor (SSTR) expression, and biochemical response. Six patients in the first
cohort each received one injection of PV-10 to one target lesion per treatment cycle. Patients are currently being enrolled into
the second cohort that allows for injection of up to three lesions per cycle.
The Company currently plans to present comprehensive clinical data at a medical conference in the first quarter
of 2019.
Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, “This poster describes Provectus’
continued progress investigating the use of PV-10, a small molecule oncolytic immunotherapy, for cancers of the liver. This work,
like similar work underway in our companion Phase 1 basket study of hepatic tumors, builds on PV-10’s extensive use in clinical
trial and expanded access settings to treat cutaneous and subcutaneous disease from melanoma and other cancers of the skin.”
Mr. Rodrigues added, “In addition to assessing the direct effect of PV-10 on injected visceral tumors, this
neuroendocrine tumor work has the potential to extend our knowledge of PV-10’s systemic benefit resulting from adaptive immune
system activation by oncolytic destruction of tumor tissue, which is fundamental to our work in melanoma. While melanoma has a high
mutation frequency and is considered one of the most immunogenic types of cancer, neuroendocrine tumors have much lower mutation
frequency, and thus are much less immunogenic. As such, this trial offers us insight into another dimension of PV-10’s use, the
treatment of immunologically ‘cold’ cancers.”
A copy of the poster presentation is currently available on Provectus’ website at https://www.provectusbio.com/media/docs/publications/ESMO-2018_Abstract_1334TiP.pdf.
About Neuroendocrine Tumors
NETs associated with the gastrointestinal tract have endocrine secretory properties and a propensity for
metastasis to the lungs, bronchi, and liver. mNETs located in the midgut and liver often secrete vasoactive products, giving rise
to symptoms such as flushing and diarrhea, wheezing, abdominal cramps, and peripheral edema.
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 small molecule chemical agents. 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
- Wachter et al. Functional Imaging of Photosensitizers using Multiphoton Microscopy. Proceedings of SPIE 4620, 143, 2002.
- 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.
- 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.
- 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.
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).
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Contact: Provectus Biopharmaceuticals, Inc. Tim Scott, Ph.D. President Phone: (866) 594-5999
