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Provectus Biopharmceuticals Highlights Stage IV M1d Patient Outcome from Combination Therapy Trial of PV-10® and KEYTRUDA® for Checkpoint-Refractory Advanced Cutaneous Melanoma at ESMO Virtual...

Complete response of all injected lesions




Regression of non-injected inguinal node, lung, and brain metastases



Expanded data set of trial subject provided

KNOXVILLE, TN, Sept. 21, 2020 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today highlighted the clinical outcome of a Stage IV M1d patient (Subject 0602) in the Company's Phase 1b/2 study of small molecule autolytic cancer immunotherapy PV-10, an injectable formulation of Provectusa?? proprietary rose bengal disodium (RBD), in combination with KEYTRUDA (pembrolizumab) for the treatment of advanced cutaneous melanoma in patients refractory to immune checkpoint blockade (CB). Preliminary response, safety, and immune correlative data from this CB-Refractory Cohort were previously presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, held online from September 19-21, 2020.This combination therapy study first enrolled and treated CB-naA?ve patients in its main cohort (CB-NaA?ve Cohort). A subsequent expansion cohort, the subject of this ESMO poster presentation, enrolled and treated CB-refractory patients (CB-Refractory Cohort).Intralesional (IL) (aka intratumoral) administration of PV-10 for the treatment of solid tumors with PV-10 can yield immunogenic cell death and induce tumor-specific reactivity in circulating T cells.1-3 This IL PV-10-induced functional T cell response may be enhanced and boosted in combination with CB.4 In CB-refractory advanced cutaneous melanoma, IL PV-10 may restore disease-specific T cell function, which may also be prognostic of clinical response.ESMO 2020 Presentation CB-Refractory Patient Highlights (Subject 0602):

74-year old male with Stage IV M1d (N3) disease



Refractory to BRAF-MEK, CB, and twice-radiotherapy brain treatments



Multiple metastases

Injectable subcutaneous (SQ) lesions



Distant metastatic sites: inguinal lymph nodes, lung, and cerebellum





IL PV-10 treatment

9 cycles to the injectable SQ lesions over a 5-month period



Median dose 0.32 mL PV-10 per cycle (range 0.15-2.46 mL)





At 28 weeks of treatment

Complete response of injected lesions



Overall: Partial response by RECIST 1.1 with regression of all non-injected metastatic sites



Provectus' current Good Manufacturing Practices (cGMP) RBD is a proprietary pharmaceutical-grade drug substance produced by the Company's quality-by-design (QbD) manufacturing process to exacting regulatory standards that avoids the formation of uncontrolled impurities currently present in commercial-grade rose bengal. Provectus' RBD and cGMP RBD manufacturing process are protected by composition of matter and manufacturing patents as well as trade secrets.
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