Clinical Trial Update

First Patient Dosed In CANbridge Pharmaceuticals CAN008 Phase 2 Trial For Treatment Of Glioblastoma Multiforme (GBM) In China

October 28,2021 09:56 AM
- By Admin

BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- CANbridge Pharmaceuticals, Inc., a leading China-based global rare disease-focused biopharmaceutical company committed to the research, development, and commercialization of transformative therapies, announced that it has dosed the first patient in the CAN008 Phase 2 clinical trial to treat glioblastoma multiforme (GBM) in Mainland China.

The multi-center, randomized, double-blind, placebo-controlled Phase 2 trial will compare standard-of-care (tumor removal, followed by radiation therapy plus temozolomide (TMZ)) with placebo, to standard-of-care with CAN008. The trial will investigate efficacy, as well as explore how select biomarkers correlate to outcome, to provide potential benefits to GBM patients.

The compound has been recognized by regulatory bodies in key international markets as potentially promising in the treatment of glioblastoma. It was granted orphan drug designation by the United States Food and Drug Administration (FDA) and received an orphan medicinal product designation by the European Medicines Agency (EMA) for the treatment of glioblastoma multiforme. In addition, it also was accepted into the EMA’s PRIME (Priority Medicines) program, which provides early and enhanced support to medicines that have the potential to address patients' unmet needs. CANbridge completed the Phase 1 clinical trial of CAN008 plus temozolomide (TMZ), during and after radiation therapy, in patients with newly diagnosed glioblastoma multiforme (GBM). The results demonstrate that CAN008 has excellent safety and tolerability in patients with GBM and could potentially improve the quality life and the survival time of the patients

“Glioblastoma multiforme is the most common primary intracranial malignant tumor,” said Professional Wenbin Li, Director of Comprehensive Treatment Ward of Neuro-Oncology, Beijing Tiantan Hospital, Capital Medical University. “Under the current standard treatment, the media survival time of patients is only 14.6 months, and the two-year survival rate is only 27%. The incidence in China has been increasing in recent years. The preliminary clinical trial results of CAN008 show that it has a good treatment effect trend, as well as very good safety and tolerability. We are pleased to participate in the domestic clinical study of CAN008 to provide a potential new treatment option for patients with glioblastoma.”

“CAN008 is our first clinical product approved to commence clinical trials that has received a Class 1 new drug designation by China Food’s National Medical Products Administration,” said James Xue, Ph.D., Founder, Chairman and CEO of CANbridge Pharmaceuticals, Inc. “The dosing of the first patient in CAN008 Phase 2 trial for the treatment of GBM in China represents a major milestone for CANbridge. We look forward to advancing this truly novel, fusion protein treatment for glioblastoma along the clinical pathway in China, where it might provide new options for patients.”

Class 1 new drug refers to new chemical entities, demonstrating clinical value, which have never been marketed anywhere in the world, and confers five years of regulatory exclusivity in China.

About Glioblastoma (GBM)

Glioblastoma (GBM) is the most common malignant tumor of the central nervous system, accounting for 35.26% – 60.9% of intracranial tumors. It is classified by the World Health Organization (WHO) as a stage-IV cancer, according to the latest classification standard of intracranial tumors. GBM is highly infiltrative and aggressive and is not surgically curable, which leads to a high recurrence rate. Although the treatment of GBM, through resection radiotherapy and chemotherapy, has continuously improved, prognosis has not been substantially improved. The median survival time is still only 14.6 months.