June 12, 2008 — Calando Pharmaceuticals, a majority-owned subsidiary of Arrowhead Research Corporation, has entered into a collaboration with City of Hope in Duarte, CA to initiate an investigator sponsored clinical trial using Calando’s nanoparticle drug candidate, IT-101, in patients with various forms of lymphoma. Calando is a biopharmaceuticals company using proprietary technologies developed at Caltech to create targeted siRNA-based therapeutics and small-molecule nanoparticle drug conjugates.
“This is a very important and exciting trial to determine the efficacy and tolerability of a rationally designed and novel nanotechnology based drug delivery system of a cancer chemotherapeutic drug, with impressive preclinical activity in lymphoma,” said lead investigator, Stephen Forman, M.D., chair, division of hematology & hematopoietic cell transplantation at City of Hope.
Earlier this month Calando announced that it had dosed its first patient with nanoparticle therapeutic.
IT-101, a drug conjugate of camptothecin and Calando’s proprietary cyclodextrin polymer nanoparticle, Cyclosert, has demonstrated a highly favorable toxicity profile and unique pharmacokinetic characteristics. Calando has recently completed enrollment of an ongoing phase I study of IT-101 at City of Hope for patients with non-resectable solid tumors and has filed with the FDA to initiate a multi-site phase II clinical trial of IT-101 in patients with ovarian cancer.
The trial will be an open-label, phase II study of IT-101 intended to demonstrate safety and efficacy in patients with relapsed or refractory lymphoma, and will be preceded by a brief dose finding run-in phase. Patients with relapsed or refractory lymphoma, including B cell, T cell, and Hodgkin Lymphoma who satisfy eligibility requirements will be considered for admission to the trial.
“We are very pleased to be working with Dr. Forman and City of Hope on this study,” said James Hamilton, M.D., CEO of Calando Pharmaceuticals. “This represents an excellent opportunity to leverage the IT-101 franchise into additional oncology indications, while minimizing clinical development costs.”