03-23-07

Media Release

Local Company, University Helping Toddler Fight for Life

CORVALLIS, Ore. – Decades of basic virology research at Oregon State University that helped support the development of an antiviral drug made by SIGA Technologies, Inc., is getting a real-world test this week as a toddler fights for survival after a near-fatal encounter with his father’s smallpox vaccination.

The drug, called ST-246, is part of SIGA’s biowarfare drug development program. It is intended to help treat smallpox and is still not approved for general use – but was called into emergency use recently when a 2-year-old child became severely ill after being with his father, a soldier who had been vaccinated for smallpox. Other efforts to help treat the problem had been unsuccessful, but the experimental drug appears to be working, news reports indicate.

This drug and several other SIGA products make use of decades of basic research in the laboratory of Dennis Hruby, a professor of microbiology in the OSU College of Science, and are now being commercialized by SIGA Technologies, a national biotechnology company with research headquarters in Corvallis.

“ST-246 was discovered elsewhere, but the poxvirus knowledge base from federally-funded basic research at OSU has certainly provided us with an excellent platform to guide its continued development,” Hruby said. “Although the drug is being developed to combat smallpox, we are appreciative of the opportunity to work with the CDC and FDA to use it to treat this gravely ill child. We are most hopeful it will contribute to a successful outcome.”

Hruby has been a faculty member at OSU since the 1980s and the chief scientific officer of SIGA since 2000. He is one of the world’s leading experts on the vaccinia virus, which was once used routinely to vaccinate people against smallpox. Since smallpox was eradicated and routine public vaccinations were halted, there has been less awareness of the sometimes-dangerous side effects from the vaccinia vaccine. But vaccinations of military and some other health workers began again in 2002, due to concerns about the possible use of smallpox by terrorists.

The drug developed by SIGA scientists is still in clinical trials, but officials say they are optimistic it will offer an effective way to treat smallpox if an outbreak were to occur.

In the recent case, the child developed a severe and life-threatening skin reaction, and was given an intravenous form of vaccinia immune globulin -- developed in the 1960s to treat complications of smallpox vaccinations. That and other treatments failed to address the problem, but the experimental drug appears to be helping, according to published reports.

The relationship between OSU and SIGA has already had significant payoffs for OSU student education and collaborative research in the past decade, officials say, and the apparent value of the new drug is a demonstration of how basic research in the academic arena can eventually lead to applications and economic growth in the private sector.

“About 25 years of basic research at OSU has set the stage for much of what we hope to accomplish at SIGA in the area of antivirals,” Hruby said. “We’re able to enhance our research operations in Oregon because of our close working relationship with the university and its substantial talent base. A lot of students do internships here, and, in turn, our staff helps teach several university courses.”

The drug being used in the recent case is one example of SIGA’s efforts to create antiviral drugs that can help treat serious illnesses where a vaccine is unavailable, too risky or not able to be prepared or deployed in time. Vaccine development is continuing as well, including work on a strep throat vaccine and a new type of smallpox vaccine – effective but without the side effects of the original.

Biowarfare concerns led to some of the original support for this work, Hruby said, but the studies should ultimately have applications for other diseases as well. Similar approaches could have use to create treatments for hemorrhagic diseases such as Ebola, tropical diseases like dengue or Lassa fever, or even SARS or avian flu.

Smallpox used as a weapon, experts say, could have an incubation time as short as seven days, allowing very little time for vaccine administration even if one were available. The use of current live vaccines for mass immunizations has been discontinued because of complications in some individuals – a problem illustrated by the severe reaction the toddler experienced.

This work has been funded primarily by the National Institutes of Health. A successful product will be available for purchase through the federal BioShield program, which is designed to improve medical countermeasures that could protect Americans from a chemical, biological, radiological or nuclear attack. That program has been allocated $5.6 billion over the next five years.