PINE BROOK, N.J., Nov. 17 /PRNewswire/ -- Elusys Therapeutics, Inc. presented post-exposure data for the first time today showing that Anthim(R), the company’s antibody treatment for anthrax toxin, improves survival when given after anthrax exposure. In addition, the Company presented new data demonstrating that its proprietary Heteropolymer (HP) technology can be used to produce drugs that protect against a variety of infectious pathogens. The data were presented today at the 2004 Scientific Conference on Chemical & Biological Defense Research in Hunt Valley, Maryland.
“These data show the strength of our monoclonal antibody-based pipeline and its broad application in the area of biodefense,” said Elusys president and CEO Stephen Sudovar. “Elusys is developing products for infectious disease based on two mechanisms of action. Our single antibody products can neutralize a pathogen and render it harmless, and our HP technology can be adapted for a broad array of pathogens to prevent and clear existing infections.”
Anthim Shows Significant Post-Exposure Benefits
Elusys scientists presented new data showing that Anthim, a single affinity-enhanced monoclonal antibody, provides significant therapeutic benefits after exposure to anthrax toxin. In the controlled study, 40 rabbits were exposed to lethal levels of aerosolized anthrax spores and then injected with Anthim 24-, 36- or 48-hours later or with placebo. Anthim improved survival at all time points, with highly significant results at 24- and 36-hour: 80% of the rabbits that received Anthim 24 hours after anthrax exposure survived the 28-day study; 50% that received Anthim 36 hours after exposure survived, and 43% treated 48 hours after exposure survived. None of the rabbits in the control group survived past the fourth day.
Elusys also presented new data on the intramuscular (IM) administration of Anthim. Eight rabbits were given Anthim intramuscularly one hour before exposure to anthrax spores, and all survived the 28-day study. None of the rabbits that received placebo survived. IM is a better method of administration than intravenous injection for emergency situations.
In a connected study, Elusys evaluated different doses of Anthim in rabbits (4 mg/kg, 2 mg/kg, 1 mg/kg and 0.5 mg/kg) to determine the lowest effective dose. The 4 mg/kg dose led to a survival rate of 88%. Four mg/kg in rabbits translates into 100 mg dose in humans, which is a low dose for antibody drugs, and is feasible to deliver via IM injection. The 2 mg/kg and 1 mg/kg doses both had survival rates of 63%. Although the 0.5 mg/kg dose had only a 13% survival rate (1 of 8 rabbits), the delay in time to death was significant. In the event of an anthrax attack, this type of delay might buy time for treatment with antibiotics.
“The data demonstrate that one dose of Anthim can be used to improve survival in a realistic time frame following exposure to anthrax, and that it can be delivered quickly, as would be necessary in an emergency,” said Leslie Casey, PhD, executive director of Elusys, who presented the data at the conference. “Even in the rabbit model which succumbs quickly to anthrax, we are seeing significant post-exposure results which bode well for our primate and human studies.”
In the coming months, Elusys will study the effectiveness of Anthim in non-human primates as well as the drug’s safety in humans.
Heteropolymer Technology Demonstrates Protective Immunity
Elusys also presented data on the power and broad applicability of its Heteropolymer, a monoclonal antibody-based technology that can potentially reduce the high mortality rate of bloodstream infections.
A drug developed with the HP technology to target West Nile Virus (WNV) demonstrated protective immunity in mice. In the study, mice were given one of two doses of the WNV drug, a single antibody or a placebo 24 hours in advance of a lethal injection of the virus. Sixty percent of the mice given 10 mcg of the WNV drug survived the 14-day study; 40% of the mice that received 1 mcg survived; 20% of the mice given the single antibody survived and 5% of the mice that received placebo survived.
In a separate study, drugs made with the HP technology that were designed to target Staphylococcus aureus bacteria were also shown to completely protect mice against infection with a lethal dose of S. aureus. In addition, all of the mice that were re-exposed to S. aureus had developed a strong immunity to the bacteria and survived.
The HP process chemically joins together two antibodies: one targets the pathogen to be removed and the other targets a receptor found on red blood cells in all primates. Elusys uses the HP technology to produce drugs that bind the pathogen to red blood cells, which carry it to the liver for destruction and return unharmed to circulate in the blood.
“We are excited about the ability of the Elusys HP technology to prevent and clear both viral and bacterial infections,” added Mr. Sudovar. “These data support our strategy of using our patented HP technology to develop drugs against a broad range of infectious diseases which are currently without effective treatments.”
About Elusys
Elusys develops antibody-based therapies using proprietary technologies in Heteropolymer antibody chemistry and complement biology. The Company’s pipeline of products includes treatments for biodefense, 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. Sharon Arnold: (973) 992-7720 Sarnoldpr@comcast.net Karen Hamel: (973) 761-0689 Gail Safian: (973) 378-3672 Gsafian@safianhealth.com
Elusys Therapeutics, Inc.
CONTACT: Sharon Arnold, +1-973-992-7720 or Sarnoldpr@comcast.net, orKaren Hamel, +1-973-761-0689, or Gail Safian, +1-973-378-3672 orGsafian@safianhealth.com, all of Safian Communications Inc.
Web site: http://www.elusys.com/
