Horold, this press release from the Diabetes Research Institute at the University of Miami adds a little more clarity to the Antova issue. I believe that Antova is very important to BGEN, and I hope that the concerns about this drug can be overcome.
drinet.org
Last night we learned of the Biogen decision to halt some of the trials with anti-CD40 ligand (anti CD-154), including the islet trial. We learned of this decision from the press release, as many of you did. The concerns on thrombo-embolic side effects resulted from observations in other trials and we have not observed such problems in association with islet transplantation. In general, there are disease states in which there is a strong predisposition to thrombo-embolic events (i.e., Lupus or following major surgery). Unlike kidney transplantation, islet transplantation consists of an infusion of cells in the portal vein and there is no surgery involved in it. In addition, experimental evidence indicates that, if anything, treatment with anti-CD40 ligand should actually inhibit clotting (thrombosis), but it is still too early to know all potential biologic effects of the drug.
We understand the company decision and we will continue to work with Biogen and the FDA to make sure all necessary safety steps are taken in a timely fashion, so that we can resume the trials as soon as possible.
We are concerned about the delay in this trial, as we still strongly believe that this drug is the best agent we have tested so far in islet transplantation, but we agree that patient safety must be an absolute priority. The Institute will continue pilot trials with other drug combinations that have been already approved by FDA, including the infusion of donor bone marrow stem cells and other emerging anti-rejection strategies.
Camillo Ricordi, M.D. |
