PINE BROOK, N.J., March 8 /PRNewswire/ -- Scientists from Elusys Therapeutics, Inc. presented data today showing that the company’s anthrax antibody, ETI-204, provides complete protection from death due to anthrax exposure in two animal species, and may clear anthrax bacteria from the site of infection and from the bloodstream. The data were presented at the American Society for Microbiology’s Biodefense Research Meeting in Baltimore.
ETI-204, an affinity-enhanced monoclonal antibody (Mab), is being developed as a drug for prevention and treatment of infection and death caused by anthrax toxin.
“ETI-204 continues to deliver strong data demonstrating its protective power at low doses,” said Linda Nardone, PhD, vice president of clinical and regulatory affairs for Elusys and director of the company’s anthrax biodefense program. “ETI-204 is one of the best anti-anthrax antibodies under development.”
Results
Leslie Casey, PhD, senior director of research at Elusys, presented the results of two key studies at the meeting. One trial showed that mice given ETI-204 fared significantly better than those given a non-affinity enhanced Mab (14B7) or placebo. The mice received ETI-204, 14B7 or placebo followed by injection of anthrax spores into the trachea. All of the mice given ETI-204 were still alive at the end of the 14-day trial. Even more significantly, none of the mice given ETI-204 had evidence of anthrax bacteria spreading to the spleen.
The second study found that the Elusys Mab completely protected rabbits exposed to aerosolized anthrax. ETI-204 was given intravenously to the animals in the study group immediately before exposure to a lethal dose of aerosolized anthrax. The control group received no drug. All of the animals given ETI-204 survived the 28-day study, whereas none of the rabbits in the control group survived past five days.
New Analyses Show Interesting Potential of ETI-204
Dr. Casey presented compelling new data based on blood samples drawn from the rabbits to determine the level of anthrax bacteria in the blood and major organs. These data go beyond the survival data for the rabbits that were previously released.
Seven of the nine rabbits treated with ETI-204 had no evidence of bacteria in the lungs, which was the site of infection, and none of the treated rabbits had bacteria in their blood at any time point. This was unexpected because ETI-204 targets the anthrax toxin, not the bacteria, yet it seems to clear bacteria from the site of infection and to keep it out of circulation in the bloodstream.
Also remarkable was that there was no evidence of ETI-204 in the bloodstreams of the treated rabbits by day 28, yet the rabbits remained free of infection.
“Our pre-exposure studies show that a single low dose of ETI-204 before exposure to lethal levels of anthrax protects the animals from death caused by anthrax toxin, but does even more than that,” commented Dr. Casey. “It was unexpected, but striking, that our Mab prevented bacteria from entering the bloodstream and cleared the bacteria from the site of infection. ETI-204 appears to have some very beneficial effects that we plan to study further.”
Finally, blood samples from the rabbits indicated that the animals developed their own antibodies to the anthrax toxin. “ETI-204 may also enable recipients to mount their own immune response to anthrax. We may test this further to verify the effectiveness and duration of this effect,” added Dr. Casey.
“We have new data showing that ETI-204 protects animals when it is given after they have been exposed to anthrax spores,” added Dr. Nardone. “In addition, we have excellent data that show protective levels of ETI-204 can be deliver by intramuscular injection, which will allow more rapid deployment than intravenous injection, especially in emergency situations.” Elusys will release the post-exposure and intramuscular data in the near future.
The Elusys Anthrax Monoclonal Antibody
ETI-204 is an affinity-enhanced, de-immunized antibody, which means that its ability to bind to its target pathogen has been strengthened and that elements that might cause an immune response have been removed. ETI-204 targets and binds to Protective Antigen, which prevents the anthrax toxins from binding to and entering the cells in the body, thereby preventing death.
About Elusys
Elusys develops antibody-based therapies using proprietary technology in Heteropolymer antibody chemistry and complement biology. The Company’s pipeline of products includes treatments for cancer, lupus nephritis, infectious diseases and thrombosis. The Company has successfully advanced three products to the IND and Phase I stage, with additional products in its pipeline. Founded in 1998, Elusys is headquartered in Pine Brook, NJ. Additional information about Elusys can be found at http://www.elusys.com/.
Contact: Safian Communications Inc. Karen Hamel: 973-761-0689 Karen.hamel@verizon.net Gail Safian: 973-378-3672 Gsafian@safianhealth.com
Elusys Therapeutics, Inc.
CONTACT: Karen Hamel, +1-973-761-0689, Karen.hamel@verizon.net, or GailSafian, +1-973-378-3672, Gsafian@safianhealth.com, both of SafianCommunications Inc.
Web site: http://www.elusys.com/
