A new and more virulent form of antibiotic-resistant staph infection has spread beyond its traditional setting in U.S. hospitals and has begun appearing with increasing – and lethal -- frequency in communities around the country. Methicillin-resistant Staphylococcus aureus infections in the community now account for 12 percent of all staph cases, according to the Centers for Disease Control in Atlanta. MRSA is significantly more lethal than the staph infections that have grown ever more commonplace in hospitals. The CDC now estimates that 89.4 million Americans carry Staph aureus in their nasal passages, and a whopping 2.3 million carry MRSA. One recently published study linked MRSA infections to the recent death of three Chicago children. Fourteen cases of skin-eating MRSA infections have appeared in the Los Angeles area. And hospitals in the Nashville area have reported a troubling surge in MRSA cases. "The times – along with MRSA colonization rates – are, indeed, changing," Drs. Clarence "Buddy" Creech II, Thomas R. Talbot, and William Schaffner, all of Vanderbilt University in Nashville, recently concluded. The longtime overuse of antibiotics has helped dilute their effectiveness, say the experts, laying the fertile groundwork for the rise of new, deadlier strains, including Clostridium difficile and Streptococcus pneumoniae. MRSA infections have proven stubborn survivors to such antibiotic standards as methicillin, penicillin and amoxicillin. Inhibitex, which has been developing what it hopes proves to be a new therapy for MRSA, estimates that 30 percent to 50 percent of hospital patients contracting an MRSA infection die and that an MRSA patient consumes an extra $27,000 in costs for an extra 12 days spent in the hospital. Those numbers have helped attract attention to Inhibitex's research into an experimental new therapy, Aurexis. "It turns out that Staph, like a lot of organisms, uses a protein on its surface to attach to human tissue," says Inhibitex CEO William D. Johnston, PhD. The concept that is driving the development of Aurexis is that their compound prevents Staph from bonding, blocking the disease before it can do any damage. Once blocked, says Johnston, the immune system can go about its clean-up role and devour the organism. Researchers at the University of South Carolina carefully tracked the cases of 60 patients with hospital-associated or community-acquired Staph bloodstream infections and found that Aurexis demonstrated positive results for mortality, relapse rates and complications. In addition, researchers said that the drug demonstrated a good safety profile with few side effects. For Alpharetta, Ga.-based Inhibitex, the results were a crucial rite of passage. Researchers will now go back and do a small safety study to see how patients respond to a higher dose of the drug. Pivotal phase III trials could come in 2009. The biotech company already has launched a late-stage trial for preventing hospital-associated infections in very low birth weight infants, a patient group that experiences an 18 percent mortality rate. Dr. Johnston feels certain that the problem is going to get much worse in the next few years "I think we're going to see continued growth in MRSA rates," he says, which are likely to reach the extremely high rates that are already being seen in England. That's likely to be a boon to Inhibitex. "The competition is very thin, especially since drug candidates for Nabi Biopharmaceuticals seem to be out of the race," Friedman, Billings, Ramsey & Co. analyst Jim Reddoch wrote recently. And that helped Reddoch estimate the potential annual revenue from Aurexis at $400 million. Health experts warn that without a solution, America's problems with MRSA are likely to worsen rapidly, with ominous implications for the healthcare system. "Two million patients contract hospital-based infections in the U.S. each year," said Betsy McCaughey, PhD, chairman of the Committee to Reduce Infection Deaths. That's one out of every 20 patients. "Infections that have been nearly eradicated in some countries – such as MRSA (methicillin-resistant Staphylococcus aureus) – are raging through hospitals in the United States." In 1974, only two percent of Staphylococcus aureus infections were drug resistant, says McCaughey. By 2003, that figure had soared to 57 percent and is still rising. And McCaughey believes these infections are almost all preventable. McCaughey's group, among others, has been warning that the steady spread of infections has demonstrated just how hard it would be for our healthcare system to deal with a human bird flu pandemic. If hospitals are already incapable of preventing well-known infections among patients, how could they hope to tackle a deadly pandemic?