ERT’s Scientific and Regulatory Consultants Support Phase III Oncology Trial
PHILADELPHIA, PA (PRWEB) October 09, 2014 -- ERT, a leading global solution provider for high-quality patient safety and efficacy endpoint data collection, today announced that Provectus Biopharmaceuticals (NYSE MKT: PVCT) is collaborating with ERT’s Clinical Outcome Assessment (COA) consultants on their Phase III trial of agent PV-10 for intralesional (IL) treatment of locally advanced cutaneous melanoma.
PV-10, an investigational new drug designed for injection into solid tumors, has received orphan drug designation from the U.S. FDA for its melanoma and hepatocellular carcinoma indications. Provectus recently presented data from their Phase II trials showing PV-10’s ablative and bystander effects, including its potential to relieve symptoms of cutaneous melanoma.
“We are thrilled to collaborate with ERT’s scientific and regulatory experts on this important program,” said Eric Wachter, PhD and Chief Technology Officer of Provectus. “Their expertise in developing and evaluating symptom measures to support clinical trial endpoints will be instrumental in helping us understand the patients’ perspective as we continue to explore the therapeutic potential of PV-10.”
ERT’s COA consultants are working with Provectus to select a patient-reported outcome (PRO) measure of symptoms in this population that can be implemented in the Phase III clinical trial of PV-10 and ultimately support treatment benefit claims in the product label.
“Provectus is a true innovator in oncology clinical research,” said Dr. Chad Gwaltney, ERT’s Chief Scientist and Regulatory Advisor, Endpoints. “By applying scientific rigor to the implementation of established PRO measures, they are not only striving to meet regulatory guidelines, they are putting the patient at the heart of clinical research. We applaud Provectus for placing such importance on understanding the patient perspective in oncology drug development, and we are delighted to work with them on this program.”
For additional information on ERT’s scientific and regulatory consulting services, visit http://www.ert.com/consulting.
About ERT
ERT (http://www.ert.com) is a leading provider of high-quality patient safety and efficacy endpoint data collection solutions for use in clinical drug development. ERT delivers a combination of technology, services, and consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle. ERT delivers the most widely deployed solutions in centralized cardiac safety, respiratory services, suicide risk assessment and Clinical Outcome Assessments (COAs) – which includes patient, clinician, and observer reported outcomes. By efficiently integrating these solutions through a system built upon a scientific and regulatory foundation, ERT collects, analyzes, and delivers safety and efficacy data critical to the approval, labeling, and reimbursement of pharmaceutical products. ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Japan, and Germany.
About Provectus Biopharmaceuticals, Inc.
Provectus Biopharmaceuticals 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 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, http://www.clinicaltrials.gov. For additional information about Provectus please visit the Company's website at http://www.pvct.com or contact Porter, LeVay & Rose, Inc.
Christine Tobin, ERT, http://www.ert.com/, +1 (412) 719-4568, [email protected]
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