KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or the "Company"), announced that data from its phase 1 study of PV-10 for chemoablation of hepatocellular carcinoma (HCC) and cancer metastatic to the liver was presented at the ESMO 17th World Congress on Gastrointestinal Cancer (ESMO-GI). The main conclusion was that preliminary evidence of efficacy in treatment of liver cancers with PV-10 was observed. The poster presentation was made by Eric Wachter, Ph.D., Chief Technology Officer of Provectus.
Provectus has previously reported data on clinical and nonclinical testing of intralesional PV-10, a 10% solution of rose bengal, as an investigational treatment for metastatic melanoma, where it has demonstrated high rates of complete response and durable local control in melanoma lesions. The current phase 1 study reported at ESMO-GI was designed to assess safety, pharmacokinetics, and preliminary efficacy of PV-10 in subjects with non-resectable HCC or other types of cancer metastatic to the liver.
In the phase 1 liver study, subjects having a target lesion in the liver at least 1 cm in diameter were administered a single percutaneous injection of PV-10 into their target lesion. Plasma concentrations of PV-10 from 1 hour to 28 days after injection were measured. Radiologic assessments of the injected target lesion were performed to determine response over an initial 28-day and longer term 9-15 month follow-up period. Serum levels of potential liver injury markers were measured, and adverse events recorded.
In the initial study cohort, six subjects received PV-10 injections in two successive escalating dose cohorts of 0.25 and 0.50 mL per cm3 lesion volume. Significant adverse events were limited to injection site and photosensitivity reactions that resolved without sequelae. All injected tumors were stable in size at 28 days, and among four of the initial six tumors that had longer-term assessment, two had partial response.
Based on these data, the researchers concluded that preliminary efficacy in treatment of liver tumors with PV-10 was observed with acceptable tolerability. The study is continuing at three study centers with two expansion cohorts to further assess safety and response in HCC and other cancers metastatic to the liver.
The poster is now available online at: http://www.pvct.com/publications/ESMO-2015-PV-10-LC-01.pdf.
About ESMO 17th World Congress on Gastrointestinal Cancer
The ESMO 17th World Congress on Gastrointestinal Cancer is the premier global event in the field, encompassing malignancies affecting every component of the gastrointestinal tract and aspects related to the care of patients with gastrointestinal cancer, including screening, diagnosis and the latest management options for common and uncommon tumors. For additional information about the ESMO 17th World Congress, please visit http://worldgicancer.com/WCGI/WGIC2015/index.asp.
About Provectus Biopharmaceuticals, Inc.
Provectus Biopharmaceuticals, Inc. specializes in developing oncology and dermatology therapies. PV-10, its novel investigational drug for cancer, is designed for injection into solid tumors (intralesional administration), thereby reducing potential for systemic side effects. Its oncology focus is on melanoma, breast cancer and cancers of the liver. The Company has received orphan drug designations from the FDA for its melanoma and hepatocellular carcinoma indications. PH-10, its topical investigational drug for dermatology, is undergoing clinical testing for psoriasis and atopic dermatitis. Provectus has completed phase 2 trials of PV-10 as a therapy for metastatic melanoma, and of PH-10 as a topical treatment for atopic dermatitis and psoriasis. Information about these and the Company's other clinical trials, including its current phase 3 study in melanoma, can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Company's website at www.pvct.com or contact Porter, LeVay & Rose, Inc.
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Provectus Biopharmaceuticals, Inc.
Peter R. Culpepper, CFO, COO
Porter, LeVay & Rose, Inc.
Marlon Nurse, DM, SVP - Investor Relations
Todd Aydelotte - Media Relations