Spotlight Innovation Inc announced that its subsidiary Celtic Biotech has begun Part 2 of its Phase I dose escalation safety study, Crotoxin in Patients with Advanced Cancer using an Intravenous Route of Administration. ImmunoClin Ltd., a company specializing in clinical development, is the contract research organization (CRO) overseeing the study conduct.
Part 2 of the Phase I study uses a revised protocol designed to determine whether faster dose escalation can be attained in a shortened time frame without increased risk to patients. The trial is being conducted at the Department of Medical Oncology at Pitié-Salpêtrière Hospital in Paris under the direction of Principal Investigator Maria A. Gil-Delgado, MD, PhD. Dr. Gil-Delgado is a member of the American Society of Clinical Oncology (ASCO). Noted French oncologist David Khayat, MD, PhD, FASCO, a Board Member of ASCO, is serving as Principal Scientific Advisor.
John Krohn, Spotlight Innovation’s President and Chief Operating Officer, said, “Commencement of Part 2 of this study is a significant step in our cancer drug development program. Crotoxin is an important new potential treatment option for patients with advanced solid tumors, and we are pleased with our progress in the clinical trial process.”
Oncology is one of four focus areas within Spotlight Innovation’s research and development pipeline; the others are chronic pain, Zika virus infection and spinal muscular atrophy (SMA).
Filed Under: Drug Discovery