Coronado Initiates Trial Of Rationally Designed Fourth Generation Doxorubicin Analogue
The first patient has been treated in Coronado Biosciences's Phase I clinical trial of CNDO101, a rationally designed fourth generation doxorubicin analogue.
The uniquely designed Phase I dose-escalation study in adult patients with advanced cancer will investigate the safety and preliminary efficacy of CNDO101 (5-imino-13 deoxy-doxorubicin). The trial has eight dose levels and allows patients to move to higher doses with each cycle if there is no evidence of toxicity. This modified design should allow the investigators to demonstrate evidence of anti-cancer activity. Coronado expects to enroll at least 30 patients in this study.
"The initiation of this clinical trial is an important milestone that marks our advancement to a clinical-stage company and is exemplary of our focus on improving cancer care," said RJ Tesi, M.D., president and CEO of Coronado Biosciences. "CNDO101 is a new drug that has been rationally designed to eliminate cardiotoxicity and improve tolerability so that it can potentially be used in combination with taxanes and other therapeutic agents to provide patients with improved treatment options. The strength of the supporting pre-clinical data and known regulatory pathway of the compound can decrease the development risk and increase the value of the compound."
The patient was treated at Holden Comprehensive Cancer Center at the University of Iowa by Raymond Hohl, M.D., Ph.D., professor of internal medicine and pharmacology and associate director of translational research at the cancer center.
"Currently available anthacyclines have some degree of cardiotoxicity that limits their use for treating many types of cancers," said Hohl, who