Skip to main content

CANbridge’s CAN-008 Approved For Phase I/II Trial In Taiwan

 

Clinical courses

CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, announced that the Taiwan Food and Drug Administration (TFDA) has approved the Investigational New Drug (IND) application for a Phase I/II clinical study of CAN-008, plus temozolomide (TMZ), during and after radiation therapy, in patients with newly-diagnosed glioblastoma multiforme (GBM). The study design  consists of an open-label, dose-escalation Phase I trial, and a multi-center, double-blind, randomized, placebo-controlled Phase II trial. The Phase I trial will evaluate safety, tolerability, pharmacokinetics and preliminary efficacy. The Phase II trial will evaluate efficacy and safety. The combined Phase I/II trial will enroll a total of approximately 55 patients.  The Phase I portion of the trial will commence in August 2016. 

“The approval of our first human clinical trial marks CANbridge’s transition to a clinical stage company, validating our business strategy and regulatory approach to develop promising Western drug candidates for underserved conditions in the Asian market, “ said James Xue PhD, CANbridge Chairman and CEO.   “That we will be moving forward in a front-line setting is also good news for glioblastoma patients in Taiwan, and the rest of Asia, who have very few treatment options.” 

“This approval by the TFDA is a very important step in the development of CAN008 for patients with glioblastoma multiforme (GBM) brain tumors,” said Mark Goldberg,  MD, CANbridge Acting Chief Medical Officer. “Glioblastoma multiforme is a devastating type of brain tumor. Better therapies are desperately needed.  We are pleased to be able to move the clinical program forward and hope that CAN008 will prove to be an important advance, improving outcomes for patients with GBM. “

<< Pharma News

Subscribe to PharmaTutor News Alerts by Email