Anthim is Safe and Provides Complete Protection from Anthrax Infection
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.
SOURCE Elusys
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Related links:
http://www.elusys.com
http://www.elusys.com/technology_hp_overview.php
CONTACT:
Bryan P. Murphy of LaVoie Group,
+1-978-745-4200 Ext. 105, bmurphy@lavoiegroup.com
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