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First Patient Dosed in CANbridge’s CAN-008 Phase I/II Trial in Newly-Diagnosed Glioblastoma Multiforme in Taiwan

2016年09月26日 PM09:02
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BEIJING

CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, announced that the first patient was dosed in the Phase I/II trial of its lead candidate, CAN-008, for the treatment of newly-diagnosed glioblastoma multiforme (GBM), in Taiwan. The patient was treated at Linkou Chang Gung Memorial Hospital, in Taipei, Taiwan. CAN-008, CANbridge’s lead candidate, is an immunotherapy that enhances the immune system response to cancer and inhibits tumor cell growth. 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 55 patients. CANbridge expects to report Phase I safety data after mid-2017.

“CANbridge is now a clinical stage company, delivering on our mission to develop Western drug candidates for Asian markets,” said James Xue, CANbridge CEO. “It is of particular value to us that CAN-008 shows promise in glioblastoma multiforme, a terrible cancer that has had no new front-line treatments approved, anywhere in the world, since 1999. We are proud to bring a potentially new treatment option to this underserved group of patients.”

“I am honored to lead this well-designed, high-quality clinical trial,” said principal investigator (PI) Kuo-Chen Wei, MD, Professor of Neurosurgery, Vice Chairman of Cancer Center, and Director of Brain Tumor Division, Linkou Chung Gung Memorial Hospital. “We look forward to doing all we can to explore CAN-008’s potential to make a meaningful difference in the treatment of GBM patients.”

About CAN-008

CAN-008 is a fully human fusion protein that inhibits the CD95 ligand, a member of the tumor necrosis factor (TNF) family. By blocking it, CAN-008 restores the immune system’s anti-tumor response and inhibits invasive tumor cell growth. In a European Phase II trial in patients with recurrent glioblastoma, conducted by the drug’s developer, privately-held Apogenix, patients with biomarkers for the CD95 ligand experienced the greatest benefits. In July 2015, CANbridge acquired an exclusive license to develop, manufacture and commercialize CAN-008 for GBM and other indications, in China, Hong Kong and Macau. The license was later expanded to include Taiwan.

About CANbridge Life Sciences

CANbridge Life Sciences, Ltd. is a bio-pharmaceutical company accelerating development and commercialization of specialty healthcare products for serious and critical medical conditions in China and North Asia (Korea and Taiwan). CANbridge develops partnerships with Western bio-pharmaceutical companies with clinical-stage pharmaceutical, medical device or diagnostic products that are either unavailable in China/North Asia or address medical needs that are underserved in the region. CANbridge also licenses, or obtains exclusive rights to commercialize, drug and device products that are approved in their home markets, for commercialization in China and North Asia.

CANbridge has an agreement with EUSA Pharma, to commercialize Caphosol® in China for the prevention and treatment of oral mucositis caused by cancer treatments, and a license with Apogenix to develop, manufacture and commercialize immune-oncology therapy, APG101, for the treatment of glioblastoma multiforme in China, Macao, Hong Kong and Taiwan, where it is being developed as CAN-008. CAN-008 is currently in a Phase I/II trial in glioblastoma multiforme (GBM) in Taiwan. CANbridge also has a world-wide license (ex-North America) with AVEO Oncology to develop, manufacture and commercialize clinical-stage ErbB3 (HER3) inhibitory antibody candidate AV-203, now CAN-017.

Led and backed by a highly-seasoned executive team, with extensive Chinese drug development experience, CANbridge has the capability to select, acquire, develop and commercialize future therapeutics and diagnostics targeting the unmet medical needs of Chinese and East Asian patients with serious or critical conditions.

CANbridge is privately-held and headquartered in Beijing, China. For more on CANbridge Life Sciences, please go to www.canbridgepharma.com.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160926005368/en/

CONTACT

CANbridge Life Sciences
James Xue, +8610.8414.8018 or
781-995-0074
CEO
or
Planet Communications
Deanne
Eagle, 917-837-5866

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