Bioscope ‘09

by  Dr. Barbara Price

Anthrax

          BARDA changed its approach to countermeasures for anthrax this month when it canceled its request for proposals for a new anthrax vaccine. The RFP was announced in Feb 2008, with a close on 29 May 2008. According to BARDA, none of the companies who submitted proposals (including Pharmathene nor Emergent Biosolutions) were likely to have their recombinant Protective Antigen (rPA) anthrax vaccine approved by the FDA within eight years. BARDA then issued a five year contract for up to $143 million to Elusys Therapeutics for their monoclonal antibody antitoxin, Anthim, which is effective even when injected up to 48 hours after anthrax exposure. Anthim works by preventing the anthrax toxin from interacting with target cells and prevents the spread of bacteria in the blood and other organs. Anthim has received FDA fast track and orphan drug designation. If licensed by the FDA, BARDA could use Project Bioshield funds to buy anthim for the Strategic National Stockpile.

          BARDA has not given up on anthrax vaccines and stated that BARDA's Broad Agency Announcement for the Advanced Research and Development of Chemical, Biological, Radiological, and Nuclear Medical Countermeasures, BAA-BARDA-09-34, issued in March 2009, could be used to fund new vaccine/adjuvant formulations. Of course, deadlines for whitepapers and other initial products have already passed, but BARDA will issue special instructions to the companies submitting RFPs using this contract vehicle. This is more paperwork that will boost the price of the final vaccine products.

          Interestingly, other news stories about anthrax include deaths from anthrax-laced heroin in Scotland and ingestional anthrax from animal hide drums at the University of New Hampshire, US. There are only about 2000 cases of cutaneous anthrax annually worldwide, and a dozen naturally occurring anthrax infections in the US since 1957. Indeed, http://www.healthmap.org, a free on-line mapping of diseases, indicates 32 cases of anthrax for 2009, globally.

Biomarkers

          Biomarkers for chemical exposures are now part of mainstream toxicology. Articles describing the high-throughput bioassays to measure changes in key enzymes and receptors, including OPs and carboxylated pesticides reflect the growing databases required for toxicity evaluation by Europe (REACH) and the US (USEPA's TRI and HPV). Those involved in research of nerve agent toxicology have learned that measuring the response of the first target, AChE, is dominant for CW agents, but although AChE remains a target, other endpoints and target cells become more important in describing and treating less toxic OPs. Hopefully these evaluations of several biomarkers for OPs, and some of the many decades of data from CW studies, will be used and the difficulties in selecting target enzymes and models acknowledged in building these databases.

For the Professional in Government and Industry with an interest in Nuclear, Biological and Chemical Defense, Disarmament and Verification; Emergency and Disaster Medical Planning; Industrial Health and Safety; and Environmental Protection