Ongoing Phase 1 basket study of PV-10 for cancers of the liver expanded to include single-center cohort of metastatic uveal melanoma patients
- Ongoing Phase 1 basket study of PV-10 for cancers of the liver expanded to include single-center cohort of metastatic uveal melanoma patients
- Presentation of initial metastatic uveal melanoma data planned for 2018
KNOXVILLE, TN, July 31, 2018 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today provided an update on the Company’s gastrointestinal (GI) cancer clinical development program for its lead investigational drug PV-10, which is administered percutaneously when targeting liver tumors.
Provectus’ ongoing, multi-center, open-label, Phase 1 clinical trial of PV-10 for patients with hepatic lesions (NCT00986661) – a “basket study” open to patients with different liver tumor types1 – has expanded to include a single-site 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 metastatic uveal melanoma patients may receive either single agent PV-10 or PV-10 in combination with standard of care checkpoint inhibition.
The Company currently plans to present initial data from the metastatic uveal melanoma cohort at a medical conference in the second half of 2018, and also plans to present updated data from the entire basket study at a medical conference in the first half of 2019.
Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, “Uveal melanoma is a rare disease, where almost half of all patients develop metastases and the vast majority of them first present with liver metastasis. Treatments for metastatic uveal melanoma, like checkpoint inhibition, typically have very low response rates.”
Mr. Rodrigues added, “Our metastatic uveal melanoma cohort expansion of the Company’s liver basket study, like Provectus’ ongoing, parallel, Phase 1 clinical trial of symptomatic neuroendocrine tumors of the liver, continues to grow the GI cancer-focused drug development of PV-10. This new work further explores the use of the Company’s small molecule oncolytic immunotherapy for another cancer indication with substantial unmet need or that is a rare disease.”
About Metastatic Uveal Melanoma
Uveal melanoma is a rare disease that is biologically and clinically distinct from cutaneous melanoma.2,3 Nearly 50% of uveal melanoma patients develop metastatic disease, with 80-90% of them presenting with liver as the first site of disease involvement.2,3,4 Outcomes of metastatic uveal melanoma are poor, with a median overall survival of 12 months and an 80% mortality rate within the first year.5 A new set of National Comprehensive Cancer Network (NCCN) guidelines for the diagnosis and management of uveal melanoma were created in 2018.6
About PV-10
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.
About Provectus
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. 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.
References
- Nine different hepatic tumor types have been treated with PV-10 to date: hepatocellular carcinoma (HCC), colorectal carcinoma, lung carcinoma, cutaneous and uveal melanomas, breast carcinoma, ovarian adenocarcinoma, and pancreatobiliary adenocarcinoma in the Phase 1 basket study (NCT00986661), and symptomatic neuroendocrine in the Phase 1 clinical trial (NCT02693067).
- Carvajal et al. Metastatic disease from uveal melanoma: treatment options and future prospects. The British Journal of Ophthalmology. 2017;101(1):38-44.
- Yang et al. Treatment of uveal melanoma: where are we now?Therapeutic Advances in Medical Oncology. 2018;10.
- 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.
- Piperno-Neumann et al. Long-term survival in metastatic uveal melanoma (MUM). Journal of Clinical Oncology. 2018:36 (suppl; abstr e21501).
6. National Comprehensive Cancer Network. Patients, Melanoma (Version 1.2018). https://www.nccn.org/professionals/physician_gls/pdf/uveal.pdf. Subscription required. Accessed July 11, 2018.
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
