- 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
KNOXVILLE, TN, Dec. 27, 2017 (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.
The article may be accessed via the Journal’s website under Published Ahead-of-Print at http://journals.lww.com/melanomaresearch/Abstract/publishahead/Quality_of_life_patient_reported_outcomes_for.99332.aspx.
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 “[b]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”):
- A focus group, which addressed initial diagnosis, treatment, disease progression and the need for self-education and support; a summary of this group’s outcome is available on Provectus' website at http://provectusbio.com/media/docs/MRF_Stage_III_Focus_Group_Summary_BRIEF_FINAL.pdf, and
- MRF’s Stage III Melanoma Patient Guide, which may be found on MRF’s website at https://www.melanoma.org/understand-melanoma/cutaneous-melanoma/stage-iii-melanoma.
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.
More information about this Phase 3 trial is available via ClinicalTrials.gov, the registry of clinical trials run by the U.S. National Library of Medicine at the National Institutes of Health (“NIH”), at https://clinicaltrials.gov/ct2/show/study/NCT02288897?term=Provectus%2C+PV-10&rank=6&show_locs=Y#locn.
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.”
About In-Transit Melanoma
According to the current NCCN Guidelines for Patients®, Melanoma, Version 1.20162, Stage III in-transit melanoma is when cancer cells have spread into lymph vessels near the first tumor but not into nearby lymph nodes. Melanoma that has spread to a small area of skin near the first tumor is called satellite metastasis. Non-metastatic recurrence is melanoma that has come back after treatment but has not spread to distant parts of the body. According to the NCCN Guidelines for Melanoma, version 1.20183, under Treatment for Stage III In-transit Disease, “[t]he tumor burden, time course of appearance, and duration of in-transit disease is variable. In some patients, in-transit lesions remain confined to a region of the body for many years. This may occur in isolation or in combination with other sites of metastatic disease. A major concern in patients in which in-transit disease occurs in isolation is the high probability of subsequent development of visceral metastasis.”
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, which can induce immunogenic cell death, is undergoing clinical study for adult solid tumor cancers like melanoma and cancers of the liver as well as preclinical study for pediatric cancers. Topical PH-10 is undergoing clinical study for inflammatory dermatoses like psoriasis; pathways significantly improved by PH-10 treatment include published psoriasis transcriptomes and cellular responses mediated by IL-17, IL-22 and interferons. 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).
1. U.S. Food and Drug Administration. Summary Basis of Regulatory Action, IMLYGIC®, October 27, 2015. https://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM473103.pdf. Accessed December 11, 2017.
2. National Comprehensive Cancer Network. Patients, Melanoma (Version 1.2016). https://www.nccn.org/patients/guidelines/mpm/files/assets/common/downloads/files/mpm.pdf. Accessed December 11, 2017.
3. National Comprehensive Cancer Network. Melanoma (Version 1.2018). https://www.nccn.org/professionals/physician_gls/PDF/melanoma.pdf (registration required). Accessed December 11, 2017.
IMLYGIC® is a registered trademark of Amgen Inc., Thousand Oaks, California, U.S.A.
Contact: Provectus Biopharmaceuticals, Inc. Tim Scott, Ph.D. President Phone: (866) 594-5999