Articles tagged with: BI-505
Press Releases»
Lund, Sweden (Press Release) – BioInvent International (STO:BINV) announces that it has decided to terminate its current clinical Phase II study with BI-505 in multiple myeloma. The decision follows BioInvent’s review and discussion with the US Food & Drug Administration (FDA), who put BI-505 on full clinical hold in November 2016.
The terminated trial, which was performed in collaboration with Penn Medicine, targeted a specific population of multiple myeloma patients undergoing autologous stem cell transplantation with high-dose melphalan.
About BioInvent
BioInvent International AB (OMXS: BINV) is focused on developing a first-in-class and …
Press Releases»
Lund, Sweden (Press Release) – BioInvent International (STO:BINV) has received verbal notice from the U.S. Food and Drug Administration (FDA) 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 …
Press Releases»
Lund, Sweden (Press Release) – BioInvent International (BINV) announced today that patient recruitment into the trial can now start in the upcoming clinical Phase II study with the antibody BI-505 in patients with multiple myeloma, as necessary regulatory approvals have been obtained. The first patient is expected to be dosed in May.
Multiple myeloma is a bone marrow cancer which affects more than 120,000 people globally every year [1]. Initial treatment is often successful, but unfortunately, most patients will relapse and in 2015, nearly 90,000 patients died as a result of the …
Press Releases»
The ability of BI-505 to prevent or delay relapse of multiple myeloma (MM) to be investigated in clinical study conducted by leading clinicians at University of Pennsylvania
Lund, Sweden (Press Release) – BioInvent International AB (OMXS: BINV) completed a strategic analysis of its ICAM-1 targeted phase II antibody BI-505 with thought leaders to garner support on the development of BI-505.
Based on the analysis of BI-505’s data, a clear direction emerged that BI-505 is uniquely positioned to increase the potential depth and quality of response in patients receiving standard of care treatment …
NewsFlash »
FDA Approves Generic Doxil – The FDA recently approved a generic version of Doxil (doxorubicin liposomal), a drug used to treat several different cancers, including multiple myeloma. Doxil was in limited supply from August 2011 to October 2012 due to manufacturing problems. However, the generic version will be readily available in 20 mg or 50 mg vials. Doxil kills cancers cells by damaging their DNA. When used as a treatment for multiple myeloma, the drug is typically combined with Velcade (bortezomib). For more information, please see the related FDA press release
Researchers Develop New Technique To Identify Kyprolis-Resistant Myeloma Cells – Researchers from George Washington University have developed a new technique that can identify multiple myeloma cells resistant to treatment with Kyprolis. The technique involves the use of an imaging dye known as CDy1, which the researchers found effective for identifying myeloma cells with high levels of the gene ABCB1. The cells with high levels of ABCB1 were found, in turn, to be resistant to treatment with Kyprolis (carfilzomib). Based on their findings, the researchers conclude that their new technique may help determine whether levels of the ABCB1 gene can predict how well a multiple myeloma patient will respond to treatment with Kyprolis. For more information, please refer to the study in the American Journal of Hematology (abstract) and the related press release from George Washington University.
MGUS Patients May Have Increased Risk Of Developing MDS – Results of a recent study indicate that, compared to the general population, patients with monoclonal gammopathy of undetermined significance (MGUS) have a 2.4 times higher risk of developing the blood disorder myelodysplastic syndromes (MDS). However, the study also found that MGUS patients do not have a significantly increased risk of developing acute myeloid leukemia or acute lymphoblastic leukemia. For more information, please see the study in the journal Leukemia (abstract).
BI-505 Shows Limited Activity In Multiple Myeloma – Preliminary results from a Phase 1 clinical trial indicate that investigational drug BI-505 shows limited activity in multiple myeloma. However, the study investigators note that the drug had a favorable safety profile. Data from the trial are available for 29 myeloma patients, all of whom had at least two previous treatment regimens before entering the trial. Increasing doses of BI-505 were tested during the study, but the best response seen was stable disease for at least two months, which was observed in 24 percent of the patients. None of the trial participants achieved a partial response or better. BI-505, which is being developed by the Swedish pharmaceutical company BioInvent, is an antibody that binds selectively to myeloma cells, triggering their death. BioInvent has described the trial results as "encouraging," and plans to test the 10 mg/kg dose of BI-505 in a future Phase 2 trial. For more information, please see the BioInvent press release.
News»
Earlier this year, an international group of myeloma experts published a review of ongoing research into new myeloma treatments. This review not only described a wide range of potential new myeloma treatments, but also included the experts' thoughts on where research into new treatments should go in the future.
Given the recent new drug application for carfilzomib and the upcoming annual meeting of the American Society of Hematology -- which undoubtedly will host discussions of many potential new myeloma treatments -- it seems an appropriate time to go back to the experts' review from …
Resources, Treatments Under Development»
| Brand Name: | |
| Generic Name: | |
| Code Name: | BI-505 |
| Company: | BioInvent |
| FDA Clinical Phase: | 1 |
Description:
BI-505 is a fully human antibody that causes cell death. It binds to the protein ICAM-1 (CD54), which is more common in tumors than in normal tissue. BI-505 may therefore be used to kill cancerous cells that have ICAM-1, including multiple myeloma cells. …
