Friday, 29/08/2008
ABthrax™
| Partners | Product | Target | Disease | PreC | PhI | PhII | PhIII | Fld | Mkt |
|---|---|---|---|---|---|---|---|---|---|
| HGSI | ABthrax™ | b.anthracis | anthrax infection |
ABthrax™ is a human, anti-protective antigen, monoclonal antibody being developed as a potential prevention and treatment for anthrax infection. ABthrax was isolated and developed by HGSI, from antibody libraries licensed from CAT. HGSI is responsible for further development and marketing of ABthrax under the terms of an exclusive licence granted by CAT in 2002.
Anthrax infection is caused by a spore-forming bacterium, bacillus anthracis, which multiplies in the body and produces lethal toxins. Research shows that one of these toxins, protective antigen, is the key facilitator in the progression of anthrax at the cellular level. ABthrax blocks the binding of protective antigen to cell surfaces and prevents anthrax toxins from entering and killing cells.
A Phase I placebo-controlled, dose-escalation safety and tolerability trial has demonstrated that ABthrax is safe and well-tolerated in 105 healthy volunteers and achieved the blood levels that would be necessary to provide significant protection from the effects of anthrax toxin.
Further development of ABthrax will continue through a two-phase contract with the US Government. Under the first phase of the contract, HGSI supplied ABthrax to the US Department of Health and Human Services (HSS) for testing. Under the second phase of the contract, HGSI will manufacture and deliver 20,000 treatment courses of ABthrax to the Strategic National Stockpile to use in the treatment of anthrax disease after the US Government exercised its option to purchase the treatment courses.
HGSI will now complete additional laboratory and clinical studies required to support filing of a BLA and to support the emergency use of ABthrax in the event of an occurence of inhalational anthrax disease.
It is anticipated that HGSI will begin delivery of ABthrax to the Strategic National Stockpile in late 2008.
To find out more about anthrax please click on the link below: