ERT's Scientific and Regulatory Consultants Support Phase III Oncology Trial
Provectus Biopharmaceuticals Collaborates with ERT's COA Experts to Understand Patient Perspective during Melanoma Drug Development
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 www.ert.com/consulting.
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