Elusys Therapeutics, Inc. Presents Positive Data On Anthrax Therapeutic At ICAAC
SAN FRANCISCO and PINE BROOK, N.J., Sept. 28 /PRNewswire/ -- Today at the 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), researchers from Elusys Therapeutics Inc., a developer of targeted anti-infective therapeutics, described results of a Phase I human clinical trial and a preclinical efficacy study of Anthim(TM), (ETI-204), the company's anthrax antibody therapeutic. To date, Anthim has been granted Fast-Track Status and Orphan Drug Designation by the U.S. Food and Drug Administration.
Elizabeth Posillico, Ph.D., President and Chief Executive Officer of Elusys Therapeutics commented on the presentations, "Anthim has now been shown to be safe, effective and well tolerated in relevant animal and human studies, with or without antibiotics. In an efficacy study, only 33 percent of animals receiving an antibiotic alone, following a lethal anthrax spore challenge, survived to the end of the study. If antibiotic therapy is discontinued at any time during a typical 60 day course of treatment, dormant spores will germinate. It is clear that Anthim represents a therapeutic that clears the infection and is effective either with or without antibiotics. In the same study, we saw 100 percent survival of animals that received a single intramuscular dose of Anthim as either a monotherapy or when co-administered with an antibiotic. Based on its continued record of impressive human safety and animal efficacy data, Anthim is an obvious choice for addition to the U.S. Government's Strategic National Stockpile."
In a podium presentation entitled "ETI-204, a Monoclonal Antibody with High Affinity Against Protective Antigen Produced by Anthrax, is Well Tolerated and Safe When Administered Alone or With Ciprofloxacin in Healthy Volunteers," Vincent Strout, Senior Director at Elusys Therapeutics, presented results of a Phase I human clinical trial designed to determine the safety and pharmacokinetics (PK) of Anthim delivered via intravenous (IV) infusion, in thirty six healthy volunteers, as a monotherapy, or when co-administered with the antibiotic ciprofloxacin.
The results of this trial show Anthim to be safe and well tolerated, with a mean half-life of 16 days. Anthim exhibited a favorable safety risk-profile as both a monotherapy and in combination with ciprofloxacin, with no serious adverse events indicating that Anthim and ciprofloxacin can be safely administered together. Adverse events were transient and mild-to-moderate in severity and were not dose dependent. Maximum serum levels of Anthim were greater than those which afforded protection in an established rabbit model of inhalation anthrax, and the half-life in humans was much longer than in rabbits.
These findings clearly support future clinical development of Anthim as a novel therapeutic agent for inhalation Anthrax. (Presented September 28, 2006 at 11:00 AM)
In a second podium presentation entitled "Intramuscular Administration of a High-Affinity Anti-Protective Antigen Monoclonal Antibody Enhances Post-Exposure Fluoroquinolone Efficacy Against Anthrax," Leslie Casey, Ph.D., Executive Director at Elusys Therapeutics, presented data from a preclinical efficacy study that investigated whether co-administration of Anthim and levofloxacin to rabbits after exposure to inhaled anthrax would result in greater survival than levofloxacin alone. This study also examined the pharmacokinetics (PK) of Anthim when delivered to non-human primates via IV and intramuscular (IM) routes.
In the efficacy study, rabbits were given a lethal inhalation anthrax spore challenge, followed 6-12 hours later by a single dose of Anthim IM and/or a five-day course of levofloxacin. Only 33 percent of animals receiving levofloxacin alone survived to the end of the study after discontinuation of treatment. In contrast, 100 percent of subjects co-administered levofloxacin and Anthim IM survived to the end of the study, a significant improvement over levofloxacin monotherapy. Further, treatment with Anthim IM 6-12 hour post-exposure as monotherapy resulted in 100 percent survival, indicating that co-administration of the antibiotic did not lead to increased survival.
In the PK study, non-human primates were given a single IV or IM dose of Anthim to study serum concentration levels. Anthim levels in sera were analyzed by anti-Protective Antigen ELISA and the results demonstrate that the bioavailability of Anthim IM (average of 83 percent) was comparable to IV administration (100 percent).
These results support development of Anthim IM as monotherapy for prophylaxis therapy and for post-exposure treatment of inhalation anthrax, with or without an antibiotic. (Presented September 28, 2006 at 10:15 AM)
Anthim Background
Anthim is high affinity monoclonal antibody that targets the protective antigen component of anthrax, blocking the bacteria's ability to form deadly toxins. It is being developed for prophylaxis and post-exposure treatment of inhalation anthrax. Anthim has been granted Fast Track status (May 2005) and Orphan Drug Designation (June 2006) by the FDA and is being developed under the FDA Animal Rule, a regulatory process specifically designed for the development of medical countermeasures to bioterror threats.
In 2005, Elusys was awarded over $5 Million from the National Institute of Allergy and Infectious Diseases (NIAID) and the Department of Defense (DoD) for advanced formulation development. To date, the Company has been awarded over $20M from the U.S. Government for the development of novel therapeutics to combat bioterror agents.
About Elusys
Elusys is a privately-held biopharmaceutical company focused on the development of targeted anti-infective therapeutics using proprietary Heteropolymer (HP) Antibodies for the treatment of infectious disease. Visit http://www.elusys.com/technology_hp_overview.php for more information on the Company's HP Antibody technology. Current venture investors include Essex Woodlands Health Ventures LLC, Invesco Private Capital, Crescendo Ventures and MedImmune Ventures. For more information please visit http://www.elusys.com.
ElusysCONTACT: Bryan P. Murphy of LaVoie Group, +1-978-745-4200 Ext. 105,bmurphy@lavoiegroup.com