KNOXVILLE, TN, Sept. 11, 2018 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that data from two ongoing clinical trials, single agent PV-10 and PV-10 in combination with checkpoint inhibition for the treatment of uveal melanoma metastatic to the liver (an expansion cohort of NCT00986661 ) and PV-10 in combination with checkpoint inhibition for the treatment of metastatic melanoma ( NCT02557321 ), will be presented in poster presentations at the SMR 2018 Congress (the Society for Melanoma Research annual meeting), held in Manchester, England from October 24-27, 2018.
The accepted abstracts are entitled:
-- “Percutaneous Oncolytic Rose Bengal Disodium for Metastatic Uveal Melanoma Patients with Hepatic Metastases,” and -- “Interim Results of a Phase 1b/2 Study of PV-10 and Anti-PD-1 in Advanced Melanoma.”
Presentation details will be announced closer to the SMR 2018 Congress.
About Metastatic Uveal Melanoma
Uveal melanoma is a rare disease that is biologically and clinically distinct from cutaneous melanoma.1,2 Nearly 50% of uveal melanoma patients develop metastatic disease, with 80-90% of them presenting with the liver as the first site of disease involvement.1,2,3 Outcomes of metastatic uveal melanoma are poor, with a median overall survival of 12 months.4
About our Phase 1 Study of PV-10 for Cancers Metastatic to the Liver
Provectus’ ongoing, open-label, Phase 1 study is evaluating the safety, tolerability, and preliminary efficacy of PV-10 in patients with solid tumors metastatic to the liver. A single percutaneous injection of PV-10 is administered to a designated hepatic tumor. Response assessments are performed at Day 28, and then every three months. Patients with multiple injectable tumors may receive additional PV-10 after Day 28.
This study also includes a single-center cohort of 10 uveal melanoma patients with hepatic metastases. This site is MD Anderson Cancer Center in Houston, Texas, and the principal investigator for the basket study’s new cohort is Sapna Patel, MD. Eligible patients may also receive standard of care checkpoint blockade immunotherapy during treatment with PV-10.
About our Phase 1b/2 Study of PV-10 + KEYTRUDA for Metastatic Melanoma
Patients with metastatic melanoma having at least one injectable cutaneous or soft tissue lesion were eligible for participation in the Phase 1b portion of the study and received the combination of IL PV-10 and KEYTRUDA every three weeks for up to five cycles (i.e., for up to 12 weeks, with no further PV-10 administered after week 12), followed by only KEYTRUDA every three weeks for up to 24 months. The primary endpoint for the Phase 1b trial is safety and tolerability. Objective response rate and progression-free survival are key secondary endpoints; both are assessed via RECIST 1.1 after five treatment cycles, and then every 12 weeks thereafter.
Preliminary results were presented at the Society for Melanoma Research 2017 Congress in October 2017. Enrollment in the Phase 1b portion of this study was completed in May 2018.
Provectus’ lead investigational oncology 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.
Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company leading the development of a new class of drugs based on halogenated xanthenes, which are chemical small molecules. 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.
1. Carvajal et al. Metastatic disease from uveal melanoma: treatment options and future prospects. The British Journal of Ophthalmology. 2017;101(1):38-44.
2. Yang et al. Treatment of uveal melanoma: where are we now? Therapeutic Advances in Medical Oncology. 2018;10.
3. Afzal et al. Metastatic uveal melanoma showing durable response to anti-CTLA-4 and anti-PD-1 combination therapy after experiencing progression on anti-PD-1 therapy alone. Journal for ImmunoTherapy of Cancer. 2018;6(1):13.
4. Piperno-Neumann et al. Long-term survival in metastatic uveal melanoma (MUM). Journal of Clinical Oncology. 2018:36 (suppl; abstr e21501).
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, 2017 ).
Contact: Provectus Biopharmaceuticals, Inc. Tim Scott, Ph.D. President Phone: (866) 594-5999