Second Study of Expanded Access Patients Treated with PV-10 for In-Transit Melanoma Published in Journal of Surgical Oncology

Thursday April 19, 2018

 

KNOXVILLE, TN, /GLOBE NEWSWIRE/ -- Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com), ("Provectus" or the "Company"), a clinical-stage biotechnology company developing PV-10 as the first small molecule oncolytic immunotherapy for solid tumor cancers, today announced that the Journal of Surgical Oncology ("JSO") had published results from an investigator-led, single-center study of patients with in-transit melanoma who received intralesional PV-10 under expanded access. The JSO article detailed the experience of investigators at the Princess Alexandra Hospital in Brisbane, Australia treating 45 patients with almost exclusively Stage III disease from 2008 to 2015.

The current article may be accessed via the JSO's website at https://onlinelibrary.wiley.com/doi/10.1002/jso.24921.1

Patients and Key Results

  • Baseline characteristics: 60% men; median age of 76 years (range 51-90); 96% Stage IIIIB-C; median of 2 prior directed locoregional therapies
  • Median of 6 lesions treated with PV-10 (range 1-31); median of 2 treatments with PV-10 (range 1-4)
  • Per patient best overall response: 42% complete response, 44% partial response, and 7% stable disease
  • 22% durable response rate (an objective response lasting more than 6 months from the time of first PV-10 treatment)
  • Median overall survival of 25 months from the first PV-10 treatment; 12-, 24-, 36-, and 48-month overall survival rates of 90%, 85%, 68% and 65%, respectively, from the time of first PV-10 treatment
  • At least one Grade 1 or 2 treatment-associated adverse event per patient; a total of three treatment-associated Grade 3 adverse events (treatment site ulceration, cellulitis, and photosensitivity reaction)

Dominic Rodrigues, Chairman of the Company's Board of Directors, said, "These data are consistent with prior analyses of patients treated with PV-10 in monotherapy settings as well as the clinical expectations underlying the design of our ongoing pivotal Phase 3 trial. This and other expanded access work, together with our historical and ongoing melanoma clinical trials, strongly support the continued relevance of PV-10 for the treatment of melanoma."

About PV-10

Provectus' lead investigational cancer drug product, 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 In-Transit Melanoma

According to the current NCCN Guidelines for Patients®, Melanoma, Version 1.2016 2, 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 1.2018 3, under Treatment for Stage III In-transit Disease, " the 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."

About Our Phase 3 Trial of PV-10 as a Monotherapy for Stage III-VI M1a Melanoma

For patients with locally advanced cutaneous melanoma, Provectus is evaluating IL PV-10 versus chemotherapy (dacarbazine or temozolomide) or oncolytic viral therapy 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 progression-free survival (assessed via RECIST 1.1 every 12 weeks up to 18 months); complete response rate and overall survival are key secondary endpoints. More information about this Phase 3 trial is available via ClinicalTrials.gov:
https://www.clinicaltrials.gov/ct2/show/NCT02288897

About Provectus

Provectus is a clinical-stage biotechnology company leading the development of a new class of drugs based on halogenated xanthenes. 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," "would," "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).

References:

1. The first study of expanded access patients treated with PV-10 for in-transit melanoma was authored by investigators at Peter MacCallum Cancer Centre in Melbourne, Australia: Lippey at al., Intralesional PV-10 for in-transit melanoma - a single-center experience. J Surg Oncol. 2016;114: 380–384. https://onlinelibrary.wiley.com/doi/10.1002/jso.24311. Accessed March 15, 2018.

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 March 15, 2018.

3. National Comprehensive Cancer Network. Melanoma (Version 1.2018). https://www.nccn.org/professionals/physician_gls/PDF/melanoma.pdf (registration required). Accessed March 15, 2018.

Contact:

Provectus Biopharmaceuticals, Inc.
Tim Scott, Ph.D.
President
Phone: 866-594-5999

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