27 November 2017
BerGenBio – US Clinical Trial Update
Bergen, Norway, 27 November 2017 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective Axl kinase inhibitors for multiple cancer indications, provides an update on BGBC004, an on-going, company sponsored US study evaluating BGB324 in conjunction with TARCEVA® (erlotinib) in patients with non-small cell lung cancer, in response to recent media coverage.
BerGenBio gained the required approvals from the US Food & Drug Administration (FDA) and from the ethics committees at the participating US hospitals prior to starting this study with BGB324. BerGenBio can confirm that it is in discussions with the Regional Ethics Committee (REK) in Bergen and the Norwegian Board of Health to gain retrospective approval to conduct the BGBC004 study in the US.
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Contact
Richard Godfrey
CEO, BerGenBio ASA
+47 917 86 304
Tom Henrik Sundby
Finance Director, BerGenBio ASA
tom.sundby@bergenbio.com
+47 477 54 415
Media Relations
David Dible, Mark Swallow, Marine Perrier
Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44 207 638 9571
About Oncoinvent
Oncoinvent is developing Radspherin®, a receptor-independent alpha radiation therapy that leverages the unique anatomy of the abdominal cavity to destroy residual micrometastases using a single, highly localized dose of alpha radiation. The initial clinical focus is treatment of ovarian and colorectal cancer patients after surgical removal of the primary tumor and visible metastases in the peritoneum, the thin membrane lining the abdominal cavity and covering the abdominal organs.
This radiopharmaceutical is designed to prevent or delay recurrence in the peritoneal cavity, keeping patients disease-free for longer than the current standard of care and thereby also impacting overall survival. It is broadly applicable to any cancer that spreads to the peritoneum, e.g. ovarian, colorectal, and gastric cancers. Radspherin® stands out for its simplicity, excellent safety profile, and seamless integration into existing surgical workflows. Oncoinvent’s product is easy to use, avoids systemic delivery and significant toxicity. It is also differentiated in being simple to manufacture, scalable, and supply de-risked.
Data from two trials in ovarian (phase 1) and colorectal (phase 1/2a) cancers, are highly promising, showing an excellent safety profile and meaningful signals of efficacy. Interim data from an ongoing, randomized, controlled phase 2 ovarian cancer trial is expected in 2026. With cost-effective manufacturing, blockbuster potential, active pharma partnership momentum, plus strong endorsements from leading experts, Oncoinvent is built for scale and commercial success, and is set to become the new standard for post-surgical cancer care. The Company was founded by the originators of Algeta and Xofigo (acquired by Bayer).
