– Key impacts comprised worry/concern, altered clothing choices, and limitations to physical functioning –
– Study results further support the clinical significance of Provectus’ ongoing, international, pivotal Phase 3 trial for locally advanced cutaneous melanoma (Stage IIIB-IVM1a) –
KNOXVILLE, TN, Oct. 23, 2017 (GLOBE NEWSWIRE) -- Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com) (“Provectus” or the “Company”), a clinical-stage biotechnology company leading the development of the first small molecule oncolytic immunotherapy, intralesional (“IL”) PV-10, as a single agent for locally advanced disease as well as in combination with another agent for widely metastatic disease, both for multiple cancer indications, today announced that results from a Provectus-sponsored study to understand the daily life experiences of patients with locally advanced cutaneous melanoma were presented at the International Society for Quality of Life Research (“ISOQOL”) 24th Annual Conference in Philadelphia, Pennsylvania from October 18-21, 2017. Patient perceptions of their experiences related to this type of melanoma are not well understood.
Adults with Stage IIIB, IIIC, or IV M1a cutaneous melanoma at cancer centers in the U.S. and Australia were interviewed to elicit their day-to-day experiences with locally advanced cutaneous melanoma, and how this type of melanoma affected their everyday lives. These cancer sufferers described their most frequent symptoms as changes in skin appearance (from spreading to surrounding skin, the appearance of a bump or lump, the increase in number of lesions, and skin discoloration), and skin pain and discomfort (from bleeding, itchiness, sores, and painful sores). The impacts of their disease symptoms on daily life were reflected in nearly 500 distinct patient expressions. The highest impact categories conveyed by these melanoma patients were emotional health in general, sadness/depression, and physical functioning limited.
Provectus currently is undertaking an international, pivotal Phase 3 study of IL PV-10 versus chemotherapy (dacarbazine or temozolomide) or oncolytic viral therapy (IMLYGIC®, the first FDA-approved IL oncolytic virus therapy) in patients with locally advanced cutaneous melanoma (the same disease of the elicitation study) (NCT02288897). Stage IIIB, IIIC, or IV M1a melanoma patients with at least one injectable lesion who are not candidates for treatment with either a checkpoint inhibitor or targeted therapy with BRAF or combined BRAF/MEK inhibitors are eligible. The trial’s primary endpoint is progression free-survival (assessed via RECIST 1.1 every 12 weeks). Complete response rate (also assessed via RECIST 1.1) and overall survival are key secondary endpoints.
Dominic Rodrigues, Chairman of the Company’s Board of Directors, said, “These elicitation study data of patient-reported assessments of disease symptoms and quality of life show that patients afflicted with locally advanced cutaneous melanoma suffer important emotional impacts, presumably because they see their disease on a continuous basis.”
Mr. Rodrigues added, “Intralesional therapy in general, and intralesional PV-10 in particular, may shrink or eliminate these patients’ accessible and visible tumors. As a result, making these noticeable reminders of mortality diminish or disappear through treatment with intralesional therapy like PV-10 could be an important benefit for these melanoma cancer patients.”
A copy of the poster presentation is currently available on Provectus’ website at http://provectusbio.com/media/docs/publications/2017p-Patient-related-Impacts-Melanoma-(ISOQOL)-18Oct17.pdf.
About Provectus
Provectus is a clinical-stage biotechnology company leading the development of a new class of drugs based on halogenated xanthenes. Intralesional PV-10, the first small molecule oncolytic immunotherapy, is undergoing clinical study for adult solid tumor cancers like melanoma and cancers of the liver, and preclinical study for pediatric cancers. Topical PH-10 is undergoing clinical study for inflammatory dermatoses like psoriasis. 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.
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, 2016).
Trademark
IMLYGIC® is a registered trademark of Amgen Inc., Thousand Oaks, California, U.S.A.
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