|HGSI's drug helps monkeys, rabbits survive anthrax|
|By Staff and Wire Reports|
|Sunday, 12 July 2009 03:00|
The treatment, ABthrax or raxibacumab, works by preventing toxins produced by anthrax bacteria from causing cell damage and death.
It is designed to work with antibiotics to improve the chances of survival in people infected with anthrax, a deadly bacteria that is a top choice as a biological weapon because it can be made into a fine, airborne powder.
Anthrax is a common disease of animals and people can catch it by inhaling the spores, getting them on the skin or ingesting them.
Quick treatment with antibiotics easily cures the infection but, by the time people develop symptoms, it is usually too late as the bacteria has pumped toxins into the body. ABthrax is designed to latch onto the toxins and disable them.
"This is a different mechanism of action than antibiotics, which have been the mainstay of treatment," Bolmer said.
Bolmer said 44 percent of rabbits and 64 percent of monkeys that got a single shot of raxibacumab survived anthrax exposure that was 200 times the average lethal dose.
"That's a very significant survival benefit. In other areas of medicine like cardiovascular disease, an improvement in mortality of 1 or 2 percent is considered medically important," she said.
The company also tested the treatment in 300 healthy people who got single or double doses or raxibacumab and found it caused no serious side effects.
Bolmer said rare side effects such as headache, pain at the injection site and mild itching were about the same in people who got raxibacumab and in those who got a placebo treatment.
The company has already submitted the data to the U.S. Food and Drug Administration.
It is the first to seek approval under a new rule that allows drugmakers to submit effectiveness data from animal studies in infectious diseases that are difficult to study in humans.
Under the so-called animal rule, companies must show the treatment works in two animal species and must produce human studies showing it is safe.
Human Genome Sciences is developing the treatment under a 2006 contract with a special agency of the U.S. Department of Health and Human Services called the Biomedical Advanced Research and Development Authority, which was formed to develop measures to counteract biological threats.
The company has already delivered 20,000 doses of ABthrax to the U.S. Strategic National Stockpile for emergency use in the event of an anthrax attack.
The Rockville, Maryland-based company began the research after attacks in 2001 in which anthrax-laced letters were sent to journalists and politicians, killing five people.
"A lot of passion went into this," Bolmer said.
HGSI has 3 entries on the BioMedReports FDA Calendar. Coming up, GlaxoSmithKline (NYSE:GSK) and HGSI expect to report the first Phase 3 data for their BENLYSTA therapy. That event, also listed and detailed on the calendar, is expected to take place very soon.