World News: 13:30 GMT Thursday 6th December 2018. [Provectus Biopharmaceuticals Inc. via Globe Newswire via SPi World News]
KNOXVILLE, TN, Dec. 06, 2018 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today provided several updates on the Company's melanoma drug development program for its lead investigational agent and small molecule oncolytic immunotherapy PV-10. Intratumoral injection of PV-10 can yield immunogenic cell death in solid tumor cancers and stimulate tumor-specific reactivity in circulating T cells.
A copy of the Melanoma Bridge 2018 poster presentation is currently available on Provectus’ website at .
In October 2018, interim safety and patient-level response data of the main cohort were . Overall efficacy (RECIST 1.1) was 9% CR, 65% objective response, and 70% clinical benefit, including 83% objective response in Stage IV M1c patients.
Mr. Dominic Rodrigues, Vice Chair of the Company's Board of Directors, said, “Systemic therapy with immune checkpoint inhibition is now recommended in the US for Stage III melanoma patients with satellite or in-transit disease. Given the changes in the melanoma treatment landscape over the last several years, as well as recent trends shaping drug development in melanoma, it is prudent for Provectus to assess PV-10’s positioning for this population of Stage III patients.”
Mr. Rodrigues added, “While enrollment in our Phase 3 trial has been challenging because of the tight eligibility criteria emanating from this study’s original design, we look forward to strong investigator interest to enroll patients in the new expansion cohort of our Phase 1b combination study of PV-10 and pembrolizumab, which has less restrictive eligibility.”
Mr. Rodrigues concluded, “The KEYNOTE-001 study of single-agent pembrolizumab demonstrated lower overall response in Stage III versus Stage IV patients and also in subcutaneous versus visceral lesions. The combination of PV-10 and pembrolizumab may represent a better treatment solution for Stage III patients than either agent alone, through the rapid and complete reduction in tumor burden from PV-10 injection, followed by the potential synergy of the two agents’ respective mechanisms of action.”
Provectus’ lead investigational oncology drug, PV-10, the first small molecule oncolytic immunotherapy, . PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and .
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, . For additional information about Provectus, please visit the Company's website at .
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Globe Newswire: 13:30 GMT Thursday 6th December 2018
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