BioInvent reports clinical hold on BI-505 phase II study
BioInvent International has received verbal notice from the U.S. Food and Drug Administration that a full clinical hold (i.e. no further dosing of patients) has been placed on BioInvent’s current clinical Phase II study with the antibody BI-505 in patients with multiple myeloma.
BioInvent has not yet received written notice of the clinical hold from the FDA, however, based on verbal communications, the FDA informed BioInvent that the clinical hold is due to an adverse cardiopulmonary event in the clinical study.
The clinical study is being conducted by BioInvent in collaboration with investigators at the University of Pennsylvania in the United States and aims to document the ability of BI-505 to deepen therapeutic response and thereby prevent or delay relapse of multiple myeloma in patients undergoing autologous stem cell transplantation (ASCT) with high-dose melphalan.
BioInvent will analyse the possibility to obtain release of the clinical hold and markets will be updated when there is further information to report.
Organizations
Other news from the department research and development

Get the life science industry in your inbox
By submitting this form you agree that LUMITOS AG will send you the newsletter(s) selected above by email. Your data will not be passed on to third parties. Your data will be stored and processed in accordance with our data protection regulations. LUMITOS may contact you by email for the purpose of advertising or market and opinion surveys. You can revoke your consent at any time without giving reasons to LUMITOS AG, Ernst-Augustin-Str. 2, 12489 Berlin, Germany or by e-mail at revoke@lumitos.com with effect for the future. In addition, each email contains a link to unsubscribe from the corresponding newsletter.
More news from our other portals
Last viewed contents

Rapid genome analysis of a Whippet sighthound sets new standard for biodiversity research - “We are demonstrating that we can obtain and analyse complete genome information in a matter of days – not months”

Unveiling a new era of imaging: Boston University engineers lead breakthrough microscopy techniques - Researchers made significant advancements in the field of vibrational imaging
Anthrax, rabbit fever and brucellosis - How can the population be better protected from highly pathogenic bacteria in food?

New corona mass test up to 100 times more sensitive than rapid antigen tests - The innovative corona test "LAMP-Seq"

Detailed structure of cell’s garbage disposal unit reveals surprise in how it is targeted by cancer drugs - Every atom counts
MIT: New cell measurement system - New system could shed light on how cells control their growth

BluSense Diagnostics - Kopenhagen, Denmark

Rice University lab encodes collagen - Program defines stable sequences for synthesis, could help fight disease, design drugs
MorphoSys Strengthens Patent Position on MOR202 Program
Traditional_Chinese_medicine
