Status: not approved; in U.S. biodefense (military) stockpile
Organizations involved:
DVC LLC – Manuf.; R&D; Tech.
DynPort Vaccine Co. LLC – Former
Computer Sciences Corp. (CSC) – Parent
Joint Vaccine Acquisition Program (JVAP), DOD – R&D; USA mark.
U.S. Army Med. Res. Acquisition Activity – R&D
U.S. Department of Defense (DOD) – Parent
Porton International – Former
Ipsen S.A. – Former
Cross ref.: See also Immune Globulin Products (#743), the main Anthrax Vaccine entry (#404), and the entries below for other Anthrax Immune Globulin products.
Description: Anthrax immune globulin refers to formulations of immune globulin containing high levels of Bacillus anthracis (anthrax) antibodies derived from pooled plasma of adults immunized with Anthrax Vaccine [see the Anthrax Vaccine (BioThrax) entry].
Equine anthrax antitoxin (immune globulin), obtained from vaccinated horses, was the only anthrax treatment available prior to antibiotics and anthrax human immune globulin. This product is still used in Russia and China.
Nomeclature: Anthrax Immune Globulin [BIO]; AIG [SY]
Companies.: The current stock (original manufacturer unknown) is controlled by the U.S. Department of Defense (DOD). DOD’s Joint Vaccine Acquisition Program (JVAP) [and/or the U.S. Army Medical Research Acquisition Activity (USAMRAA)] plans to use its master biodefense R&D contract with DVC LLC, a subsidiary of Computer Sciences Corp. (CSC), formerly DynPort Vaccine Company LLC, to manufacture and test additional supplies from DOD-held plasma from BioThrax vaccinated DOD employees (soldiers). DynPort was a joint venture of Porton International, a subsidiary of Ipsen S.A. DynCorp.; later became DVC and fully owned by CSC.
FDA class: Biologic
Status: This product has not been approved. The current supply of anthrax immune globulin was collected from U.S. Department of Defense (DOD) personnel having received anthrax vaccination. Only 135 units (~600 mL/unit) of plasma have been reported to be currently available, enough for animal testing and testing/use in a few dozen patients. Through its contract with DynPort/DVC, the JVAP, DOD is planning to collect and process a second, larger batch of plasma from anthrax-vaccinated military personnel.
Anthrax immune globulin is available under IND for emergency use. However, antibiotics, supplemented with anthrax vaccine (BioThrax/AVA), is now the standard treatment for anthrax spore exposure.
R&D: Elusys Therapeutics Inc. is developing Anthim, a therapeutic affinity-enhanced recombinant monoclonal antibody with specificity for B. anthracis protective antigen to inhibit binding of anthrax toxins. Phase I studies began in late 2005. An IND to begin Phase I trials was approved in Aug. 2005. The company received $4.4 million from the National Institute of Allergy and Infectious Diseases (NIAID), NIH, and $1 million from the DoD for Anthim development in Aug. 2005.
Medarex, Inc. and PharmAthene, Inc. are jointly developing Valortim, a recombinant fully human antibody using Medarex’s UltiMAb Human Antibody Development System that targets B. anthracis protective antigen. The IND for Valortrim was granted fast track status.
Virionyx (South Auckland, New Zealand) and Zeptometrix Corp. (U.S.) are developing Trithrax, a polyclonal immune globulin from immunized goats. They hope to sell this to the U.S. government (and others) for about $7,200/treatment. Trithrax is currently in early trials.
Human Genome Sciences, Inc. is developing and has received a Department of Health and Human Services (DHHS) contract (HHSO10020050006C) for development, manufacture and supply of stocks of ABthrax (raxibacumab), a recombinant human B. anthracis monoclonal antibody. The company received a two-phase federal contract in Oct. 2005. In the first phase, for $1.8 million it will supply of 10 grams of ABthrax. The second phase, in the future, would be for development and manufacture of 10,000 to 100,000 doses for the Strategic National Stockpile. Positive Phase I trial results with ABthrax were reported in July 2005.
Index Terms:
Companies involvement:
Full monograph
744 Immune Globulin/DVC
Nomenclature:
Anthrax immune globulin/DVC [BIO]
AIG [SY]
FDA Class: Biologic BLA
antibodies (see also immune globulins; monoclonal antibodies)
biopharmaceutical products
blood products
human materials used<!-- humansource -->
immune globulins, Fab fragments <!-- immunoglobulins -->
immune globulins, Fab fragments <!-- immunoglobulins -->
anthrax prophylaxis
BHK-21 (C-13)
conjugates
implants
North American coral snake
EU000 Not yet/Never filed with EU
UM100 Controlled/Gov't Distribution in US
US000 never filed/no plans
US666 Biodefense stockpile
EM999 Not Available/Not Marketed in EU
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