An experimental drug manufactured by a little-known San Diego company, called Mapp Biopharmaceutical, is now at the forefront in the fight against the recent Ebola virus outbreak that has claimed almost 900 lives. The research in the production of monoclonal antibodies, as the drug is classified, is being conducted in several institutions around the globe, including the National Microbiology Lab of Canada. The experimental and unlicensed drug, which was referred as a “secret serum” is manufactured from tobacco, and may have saved the lives of two Americans who recently contracted the deadly Ebola virus while on aid missions in Liberia.
The San Diego Company has partnered with a competitor known as BioLeaf, which recently acquired the rights to a cocktail of three monoclonal antibodies. The cocktail, now known as ZMapp, was given to Dr. Kent Brantly and Nancy Writebol, before they were transferred from the continent to the U.S. last weekend. Dr. Brantly was transferred to an isolated treatment unit at the Emory University Hospital in Atlanta, on the weekend, while missionary Nancy Writebol arrived on Tuesday, August 5. They were both given doses of the test serum that was flown to Liberia and arrived on July 31.
Although the drug has not been approved, by any regulatory body for the treatment of the Ebola virus, and is still strictly experimental, the FDA occasionally allows distribution of experimental drugs without approval in cases that are considered life-threatening. They also allow access in conditions that can be described as circumstances of compassion.
ZMapp had been previously tested only on a small group of monkeys, who all survived after being treated within 24 hours of being infected. The frozen serum required up to 10 hours to thaw, while Brantly and Writebol waited and their conditions worsened. Both were warned that the drug had not been approved, but were willing to try the treatment. Reports indicate that Dr. Brantly showed a positive response after only one hour of being treated. He showed much improved breathing and better mobility after being ill for nine days, as his rash subsided and he was able to move without assistance. Nancy Writebol, who is older, required an additional treatment before her condition stabilized enough for her to be transported.
The drug is produced from tobacco plants, which have been genetically modified to produce the monoclonal antibodies. The bioengineering is done by a subsidiary of Reynolds American, known as BioProcessing of Owensboro in Kentucky. The company was asked for a limited supply to treat Writebol and Brantly, and representatives for tobacco giant Reynolds said that the FDA granted an Investigational New Drug status.
As the death toll from the Ebola virus outbreak continues to climb with more infections being reported daily, there is now some hope that the spread of the outbreak can be curtailed by targeting it with experimental drugs such as ZMapp, but researchers admit that there is still a lot of work to be done. The manufacturers of the drugs hope that Phase I clinical trials can begin in a few weeks, where additional testing and more extensive studies will involve healthy volunteers, and the determination of appropriate doses.
By Dale Davidson