Calando Pharmaceuticals Phase II Clinical Study Opens to Patient Enrollment
News Sep 12, 2008
Calando Pharmaceuticals, Inc. has announced that it has initiated a Phase II clinical trial in the United States evaluating the safety and efficacy of its drug candidate, IT-101 in patients with platinum-sensitive ovarian cancer. The study is open for enrollment.
Previous work with IT-101 suggests that twice monthly "maintenance doses" of IT-101 given after the patient's standard chemotherapy may have minimal side effects, allowing for improved quality of life, and improved progression free survival.
This Phase 2 study is designed to determine if IT-101 treatment initiated after a standard 2nd line course of platinum chemotherapy in patients who have stable disease, a partial response, or a complete response can delay disease progression.
The study is expected to enroll 150 patients in the United States and is co-led by Jonathan S. Berek MD, MMS, Professor and Chair, Department of Obstetrics and Gynecology, Stanford University School of Medicine and the Stanford Cancer Center and Franco Muggia, MD, Anne Murnick Cogan and David H. Cogan Professor of Oncology, Director of the Division of Medical Oncology at NYU Medical Center, and Associate Director for Clinical Research.
A team of experts from Dana Farber, Sloan Kettering, Columbia University, and M.D. Anderson comprise the Data Safety Monitoring Committee.
IT-101, a conjugate of camptothecin and Insert's proprietary cyclodextrin polymer nanoparticle, Cyclosert™, has demonstrated a highly favorable toxicity profile and pharmacokinetic characteristics.