Like everyone I am very excited about the prospect of Mapp Biopharmaceutical's innovative tobacco-based monoclonal antibody product, ZMapp, dministered to both individuals with Ebola who were subsequently transported to Atlanta. One of these patients is ambulatory and the other is able to eat--encouraging signs of recovery.
Monoclonal antibodies are a promising new technology used in host of illnesses and provide an elegant means to avert the use of antibiotics by using a rationally-designed targeted treatment. I spent a lot of thinking about monoclonal antibodies working as a team member on this project (in which we even interviewed Mapp's Larry Zeitlen). Currently, the only FDA-approved monoclonal antibodies for infectious diseases are for RSV and anthrax.
There have been reports labeling these drugs as a "miracle cure" with near instantaneous effects. I believe that people should be cautious, as NIAID director Dr. Anthony Fauci noted, about such interpretations for a number of reasons that include:
- The small number of humans (2) that have received the drug--were these two already going to recover without this medication and was ZMapp administered on the cusp of convalescence?
- The presence of confounding effects: Atleast one patient received convalescent sera prior to ZMapp, a treatment that likely has some efficacy on its own.
- The lack of published data from these patients on such biomarkers as viral load, liver function tests, blood clotting times, etc.
In short, much excitement is justified and this drug has proven to be highly efficacious in non-human primates. However, I think that more data is clearly needed to establish causation with respect to the course of illness in these two patients (and I am confident it will emerge as more individuals are administered this treatment). But I, for one, am cheering the use of monoclonal antibodies for the treatment of an infectious disease.