First Study of Quality of Life of Patients with Locally Advanced Cutaneous Melanoma Published in Melanoma Research
- Emotional health/self-perception issues were most common; limitations of lifestyle and activities as well as coping strategies were also important - - Provectus Biopharmaceuticals expands pivotal Phase 3 trial of intralesional PV-10 for this patient population to EU and LATAM; U.S. sites continue to enroll -
Wednesday December 27, 2017
KNOXVILLE, TN, /Globe Newswire/ -- Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com), ("Provectus" or the "Company"), a clinical-stage biotechnology company developing the first small molecule oncolytic immunotherapy for solid tumor cancers, today announced that Melanoma Research (the "Journal") published results from a Provectus-sponsored study to understand the daily experiences of patients with locally advanced cutaneous melanoma. Physical and emotional experiences, symptom management, and subsequent impacts on quality of life historically have not been well understood or sufficiently described for this patient population.
Interviews of adults with Stage IIIB, IIIC or IV M1a cutaneous melanoma at three cancer centers in the U.S. (Moffitt Cancer Center, Tampa, Florida and Huntsman Cancer Institute, Salt Lake City, Utah) and Australia (Melanoma Institute Australia, Sydney) were conducted to assess how locoregionally advanced cutaneous melanoma impacted everyday life. According to the Journal article, "[e]motional health/self-perception issues were the most commonly identified (41% of patient impact expressions), including worry, concern, embarrassment, self-consciousness, fear, and thoughts of death. Limitations of lifestyle and activities were also identified (28% of expressions) including leisure and social activities, physical functioning, general functioning, and personal care. Coping strategies such as modified clothing choices, increased use of pain and/or anti-inflammatory medications, and avoidance/protection from the sun represented 20% of all impact expressions."
Study investigators "collected information on disease-specific patient-reported assessment of symptoms and quality of life (patient-reported outcomes, or PROs) that may provide a basis for supporting the clinical significance of objective response parameters such as progression-free survival (PFS) and complete response."
The Journal article also noted that "oth the US Food and Drug Administration and the European Medicines Agency have highlighted the value of establishing content validity in the development of tools to assess patient-reported outcomes. Such PRO-geared tools can extract critical concepts and impacts pertinent to the patient experience. Focus groups and interview sessions can be among those tools to elicit the patient experience."
Provectus previously supported Stage III melanoma patient advocacy efforts by the Melanoma Research Foundation ("MRF"):
In its Summary Basis of Regulatory Action for IMLYGIC®1, the first intralesional therapy approved for melanoma, the U.S. Food and Drug Administration ("FDA") noted that "patients and their caregivers spoke of the value, both cosmetic and psychological, of watching their skin lesions disappear" during the April 2015 Joint Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee. The FDA also noted "[t]here may be associated psychological benefit, which may be substantial in patients who can see their visible lesions recede."
For patients with locally advanced cutaneous melanoma, Provectus is evaluating intralesional PV-10 versus chemotherapy (dacarbazine or temozolomide) or oncolytic viral therapy (IMLYGIC) in an international, multi-center, pivotal Phase 3 trial (NCT02288897). In-transit, satellite and locally recurrent melanoma patients (Stage IIIB, IIIC or IV M1a) 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 PFS (assessed via RECIST 1.1 every 12 weeks up to 18 months); complete response rate and overall survival are key secondary endpoints. PV-10 currently is or soon will be available at 19 clinical sites in five countries. The study is enrolling in Germany, Italy and the U.S., and clinical trial authorizations have been received for France and Mexico.
Dominic Rodrigues, Chairman of the Company's Board of Directors, said, "Provectus has had a longstanding commitment to understanding quality of life issues in order to better design our clinical trials. We believe the endpoints of our pivotal Phase 3 trial for locally advanced cutaneous melanoma, like progression-free survival and complete response rate, are congruent with the findings of this quality of life study that highlight patients' emotional and physical challenges, which owe to their persistent, visible disease."
Mr. Rodrigues added, "We are grateful to our regulatory partners at FDA, Therapeutic Goods Administration, Agenzia Italiana del Farmaco, Bundesinstitut für Arzneimittel und Medizinprodukte, Agence Nationale de Sécurité du Médicament et des Produits de Santé, and Comisión Federal para la Protección contra Riesgos Sanitarios for working with Provectus to achieve clinical trial authorization in their respective countries for this important trial, and to enable the Company to continue the drug development work required to advance delivery of accessible and affordable healthcare around the globe via PV-10, the first small molecule oncolytic immunotherapy for melanoma."
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