Provectus to Present Additional Results in 80 Patient International Multicenter Phase 2 Clinical Tri
Provectus to Present Additional Results in 80 Patient International Multicenter Phase 2 Clinical Trial in Metastatic Melanoma at European Cancer Congress 2013
Abstract Now Available Online
KNOXVILLE, Tenn.--(BUSINESS WIRE)-- Provectus Pharmaceuticals, Inc. (OTCQB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announces that analysis of data from its completed Phase 2 study of intralesional PV-10 in metastatic melanoma will be presented at the upcoming European Cancer Congress (ECCO 17- ESMO-38 - ESTRO 32), taking place September 27 through October 1, 2013 in Amsterdam, The Netherlands.
PV-10, a 10% solution of Rose Bengal that is currently being examined as a novel cancer therapeutic, is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, minimizing potential for systemic side effects. The international, multicenter, Phase 2 study of 80 subjects with AJCC Stage IIIB-IV melanoma examined the effect of up to 4 treatment cycles of intralesional (IL) PV-10 in patients with refractory, locally advanced disease. Interlesional PV-10 tumor ablation provided, with minimal intervention, rapid locoregional disease control. The high rate of bystander lesion response and reversible cutaneous locoregional blistering (prognostic for patient response), are consistent with the novel tumor-specific immune mediated mechanism of action of PV-10.
As previously announced, this data from the Phase 2 study was submitted and accepted for presentation at ECCO. Abstract No. 3.755, entitled, "Locoregional Disease Control in Metastatic Melanoma: Exploratory Analysis From Phase 2 Testing of Intralesional Rose Bengal," is authored by S.S. Agarwala, J.F. Thompson, B.M. Smithers, M.I. Ross, B.J. Coventry, D.R. Minor, C.R. Scoggins, J. M. Singer and E.A. Wachter, and can be accessed at the following link:
In the phase 2 study, up to 10 cutaneous or subcutaneous target lesions and up to 10 additional non-target lesions received intralesional PV-10 at day 0 and could be reinjected as necessary at weeks 8, 12 and 16 if tumor tissue remained. Up to 2 additional cutaneous or subcutaneous lesions were left untreated to assess bystander response. The primary endpoint in the single arm trial was best overall objective response rate (BORR) judged by RECIST in each subject's target lesions.
Results showed that for all subjects, BORR was 51% (26% CR, 25% PR) with the amount of tumor burden accessible to PV-10 injection prognostic for outcome. In the majority of subjects (66%) the lesions treated with PV-10, together with up to two untreated bystander lesions, constituted all disease present, and these subjects achieved a BORR of 62%. In subjects where all disease was treated (33% of subjects) BORR further increased to 73%.
The new data analysis described in Abstract No. 3,755 further examines these response rates relative to a specific reaction, locoregional blistering, observed in 40% of subjects. This phenomenon, which generally occurred within seven days of PV-10 injection but with no clear pattern of incidence, typically resolved within four weeks. Appearance of this potentially immune-mediated effect was strongly predictive of outcome. Subjects who developed blisters had 66% BORR vs. 42% for those not developing blisters. The correlation between occurrence of blisters and locoregional disease control was even stronger. Among subjects with blisters, 90% achieved stable disease or better vs. 54% of subjects without blisters. The researchers conclude that for patients who are refractive to other local treatments such as surgery and radiation, intralesional PV-10 provides a viable strategy to maintain locoregional control of the disease with minimal intervention, and can potentially delay, reverse or prevent progression to life-threatening visceral disease.
Sanjiv S. Agarwala, MD, Principal Investigator for the Phase 2 trial of PV-10, and Chief of Medical Oncology and Hematology at St. Luke's Hospital and Health Network in Bethlehem, PA, will present the detailed findings of this exploratory analysis during the Poster Session on "Melanoma and Skin Cancer" scheduled for Monday, September 30, 2013 from 9:30 a.m. to 12:00 noon.
As founding members of ECCO - the European CanCer Organisation, ESMO, ESTRO, ESSO, EACR, EONS and SIOPE, are joining together again to form a powerful combination of seven senior organisations endorsing multidisciplinarity as the way forward to best improve the prevention, diagnosis, treatment and care of cancer patients.
This renowned biennial series of multidisciplinary European Cancer Congresses are recognized as the premier cancer meetings in Europe. The 17th ECCO - 38th ESMO - 32nd ESTRO European Cancer Congress being held in Amsterdam, September 27 - October 1, 2013, will once again combine the united efforts of all partner organisations to continue positioning multidisciplinarity as the way forward to best improve the prevention, diagnosis, treatment and care of cancer patients. The recognized multidisciplinary setting of the Congress will provide ideal surroundings for participants to leverage knowledge, promote education and build awareness about oncology - placing the patient at the heart of all our efforts and discussions.
About Provectus Pharmaceuticals, Inc.
Provectus Pharmaceuticals specializes in developing oncology and dermatology therapies. Its novel oncology drug PV-10 is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly 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. Its dermatological drug PH-10 also targets abnormal or diseased cells, with the current focus on psoriasis and atopic dermatitis. Provectus has recently 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 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.
FORWARD-LOOKING STATEMENTS: The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.
Provectus Pharmaceuticals, Inc.
Peter R. Culpepper, CFO, COO, 866-594-5999 #30
Porter, LeVay & Rose, Inc.
Marlon Nurse, DM, SVP - Investor Relations
Bill Gordon, SVP - Media Relations
KEYWORDS: United States Europe North America Netherlands Tennessee
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