< Back | Home

Microbiology professor Dr. Dennis Hruby is the Chief Scientific Officer at SIGA Technologies. SIGA is developing a drug that could compat the Smallpox virus.

A life on the line, an experimental drug to try

Experimental new drug made by OSU professor offers dying child last chance for survival

By: Lisa Riordan

Posted: 6/7/07

In March 2007, a 2-year-old boy lay dying in a Chicago hospital bed, stricken with a rare affliction not seen since the 1990s. Known treatment avenues had failed, leaving doctors skeptical about the toddler's chances for recovery.

In addition to other signs and symptoms, the boy developed a severe systemic skin reaction that rendered him virtually unrecognizable. The rash, typical of eczema vaccinatum, blanketed the toddler's body in a harrowing shroud of purple sores and bloody skin.

Desperate to save a life not fully lived, health care officials sought out promising new drug - ST-246. The experimental drug, never before tested in children, was immediately airlifted from Oregon and was promptly administered in solute form.

To the collective relief of everyone involved, the boy's condition improved quickly.

Thanks to SIGA Technologies Inc. and ST-246, the boy who wasn't expected to make it through the weekend was discharged April 19.

He is expected to experience some permanent scarring due to the severity of the skin reaction, but will otherwise make a full recovery.

"It was the most terribly exciting, terribly frightening thing I've ever been a part of," said OSU faculty member Dennis Hruby, a 1973 OSU graduate and Chief Scientific Officer at Siga.

OSU graduate Melissa Lehew, executive assistant and officer manager at Siga, described the experience as nerve-wracking.

"We were all on the edge of our seats," Lehew said. "It was a stressful time."

Hruby, a leading pox specialist, was contacted by the Centers for Disease Control one Saturday afternoon in March. Officials debriefed him on the unique case of a boy who developed eczema vaccinatum after visiting with his father, an Iraq-bound soldier recently vaccinated for smallpox.

"The father was supposed to leave for duty, but I guess he was granted an unexpected furlough," Hruby said.

"So this guy had just gotten the smallpox vaccine, then he went home to visit with his family. Well the virus used in that vaccine, vaccinia, normally sheds from the site of inoculation for a couple weeks."

Apparently still shedding from the injection site, the father ventured home, unknowingly exposing his family to the vaccinia virus.

"People receiving the smallpox vaccination are supposed to avoid contact with children, people with cuts, or the otherwise immunocompromised," Hruby said. "And as it turns out, the boy already suffered from eczema. So with all those open sores, it's no wonder he contracted Vaccinia."

The boy had suffered from severe health problems throughout his life - including eczema, a skin disease. Skin lesions, like those caused by eczema, can make individuals more susceptible to infection.

CDC officials questioned Hruby about Siga's newest drug development, in the hopes that it would help save the dying boy. Still in the experimental phase, ST-246 is an oral anti-viral medication designed to combat smallpox.

The virus used in smallpox vaccinations, the vaccinia virus, is structurally similar to the smallpox virus. So theoretically, a drug designed to defeat smallpox would also work against vaccinia, and vice versa.

"They explained the situation to me ... we discussed it ... and in the end, we decided to give it a go," Hruby said. "Then the CDC got a teleconference with the FDA. We told them what we were going to do, and they granted permission."

Officials arranged for a private charter plane to immediately transport Hruby and his life saving cargo. The redeye flight departed from Oregon on Saturday night and landed in Chicago around 3 a.m. Sunday morning. From there, Hruby traveled to the hospital and met with pharmacy staff to discuss the logistics of administering ST-246.

"It was designed as an oral medication, and there was no way this child could have taken anything by mouth," Hruby said. "So we had to be creative."

In the end they decided to open the capsule, emulsify its contents, and deliver it through the child's feeding tube.

"The medicine had been tested in humans for safety, but it had never been in a child or a diseased person before," Hruby said. "We had to use our best judgment as far as dosage was concerned."

The child received his first dose of ST-246 by 9 a.m. Sunday morning, showing marked improvement almost immediately.

Health officials remained in constant contact with Hruby, closely monitoring the child for changes and scrutinizing lab results.

"We were having daily phone calls with as many as 50 people on the phone," Hruby said.

With 25 years experience in pox viruses, Hruby is an expert in his field. He founded Siga Technologies in 1996, a flourishing biotechnology company with locations in both New York and Corvallis.

The company designs and develops products for the prevention and treatment of a myriad of infectious diseases, including broad spectrum antibiotics designed to quash antibiotic resistant infections.

"We're doing a lot of exciting things right now, like our work in hemorrhagic fever viruses [such as ebola, lassa fever]," Lehew said. "And of course, smallpox."

Officially eradicated in 1977, the last known samples of smallpox are purported to be located at the CDC headquarters in Atlanta and a research facility in Russia.

This assertion is contested by Hruby, who cites the looming threat of bioterrorism as the chief motivator in the development of ST-246.

"During the Cold War, the Soviet Union was developing smallpox to use as a weapon. After the break up of the SU, thousands of scientists were suddenly out of work and nobody knows where they all went... or what happened to all the missing samples."

Hruby is concerned that samples could fall into the wrong hands.

"If smallpox were to be released on a subway in New York, the effects would be devastating," Hruby said. "Except for the military, people aren't getting vaccinated anymore ... we're very vulnerable."

Siga created the drug with plans to market it to the government. The company hopes the government will stockpile ST-246 for use in emergency situations. According to those close to him, Hruby remains modest and unassuming, despite his recent success.

"He is still the same guy I go fishing with," said Peter Bottomley, an OSU microbiology professor who has been a colleague and a friend to Hruby for more then 20 years. "He hasn't let any of it go to his head."

Hruby said he has no plans to leave OSU, and will remain committed to the university for years to come.