PINE BROOK, N.J., April 22 Elusys Therapeutics, Inc.(Elusys), a privately-held biopharmaceutical company developing antibody-basedtherapies for the treatment of life-threatening infectious diseases, todayannounced pivotal animal efficacy results of Anthim(TM), a high-affinityhumanized and deimmunized monoclonal antibody targeting the anthrax toxinprotective antigen.
Elusys' Anthim is designed as a "just in time" anthrax therapeutic thatcan be administered by a single, rapid intramuscular injection and has thepotential to provide quick protection against the lethal effects of anthraxtoxin.
In this study, primates were infected with a highly lethal dose ofaerosolized anthrax spores and observed for 60 days. A single IM dose ofAnthim provided significant protection (75% survival) when administered at theonset of clinical symptoms of disease (24 hr. post exposure). These resultsare consistent with a recent rabbit study that showed significant survival ofanimals treated 24 hours after infection when bacteremia was present.
Elizabeth Posillico, Ph.D., President and Chief Executive Officer ofElusys, commented on the results, "Anthim continues to demonstrate life-savingpotential when given in a single, low IM dose after clinical symptoms ofinfection are present. In earlier animal studies, Anthim provided 100 percentprotection when given prior to an anthrax exposure. These results have beenconsistent across studies whether Anthim was used with or without antibiotics.Our Phase I human safety study demonstrated Anthim is safe and well-toleratedas a monotherapy and as a combined therapy with the antibiotic ciprofloxacin."
Dr. Posillico continued, "Death from the effects of anthrax toxin canoccur in a few days if patients are not treated quickly. We are very excitedbecause the results of our studies show that rapid IM treatment with Anthimhas the potential to provide 'instant protective immunity' against the anthraxtoxin in a bioterrorism emergency. We believe Anthim represents an extremelyimportant medical countermeasure for the treatment of anthrax and should beadded to the National Stockpile."
Currently antibiotics represent the only option for the treatment ofanthrax infection. Antibiotics may be effective in killing the bacteria, butcan still fail to prevent death from the damaging effects of anthrax toxins.In addition, current antibiotics may not be effective at all againstantibiotic resistant strains of anthrax.
Anthim is a high-affinity, humanized and deimmunized monoclonal antibodythat targets the protective antigen of B. anthracis and neutralizes the lethaleffects of anthrax toxins. It is being developed for prevention and treatmentof inhalation anthrax. Anthim has been granted Fast-Track status and OrphanDrug Designation by the FDA and is being developed under the FDA Animal Rule,a regulatory process specifically designed for the development of medicalcountermeasures to bioterror threats. Elusys has been awarded $32 millionfrom the National Institutes of Health and the Department of Defense fordevelopment of Anthim, of which $12 million was awarded in September 2007 fromthe National Institute of Allergy and Infectious Disease (NIAID), NationalInstitutes of Health, and the Biomedical Advanced Research and DevelopmentAuthority (BARDA), Department of Health and Human Services for advanceddevelopment of Anthim. In April of 2007, Anthim was selected to R&DDirections' list of "100 Great Investigational Drugs."
Based in Pine Brook, New Jersey, venture-backed Elusys has two corporatepartnerships with MedImmune and Pfizer for development of its HP Antibodiestargeting select infectious diseases. Current venture investors include EssexWoodlands Health Ventures LLC, Invesco Private Capital, Crescendo Ventures,MedImmune Ventures and Pfizer. For more information