Mt. Pleasant’s GenPhar at forefront of bioterrorism fight

Tucked away in an inconspicuous brick office building off Johnnie Dodds Boulevard, a Mount Pleasant company stands apart from the numerous real estate agencies, medical practices and consulting firms nearby.

Tiny GenPhar Inc. is on the forefront of research against potential biological nightmares such as avian flu, the West Nile virus and HIV.

More recently, the local pharmaceutical company has made strides by developing a vaccine that was 100 percent effective in recent trials against the Ebola virus, one of the world’s deadliest pathogens.

GenPhar, working with the Army’s Medical Research Institute of Infectious Diseases, recently exposed rhesus monkeys to the virus at 1,000 times the lethal dose, with not a single monkey getting sick.

The FDA said it couldn’t comment on whether the vaccine would be approved. However, the promising results could mean a marketable vaccine within a year.

The Ebola virus has killed a few thousand people since the 1970s, when it first was discovered, but with a 50 percent to 100 percent fatality rate, it’s one of the deadliest pathogens known.

“This virus is very dangerous,” said Dr. John Dong, co-founder, president and chief scientific officer of GenPhar. “If it spread into a modern city with a dense population, it’s basically a disaster.”

Ebola, and its cousin, the Marburg virus, cause high fever, nausea, dizziness and, in some cases, hemorrhagic bleeding.

“We have a product that will save lives, help the nation and gets a good economic return, and that’s what we focus our business model on,” Dong said.

Dong said he anticipates that a lot of goverment grants will go toward biological threat in the future, and that is the direction he hopes to steer his company.

“This is the type of business that should be developed in South Carolina, especially in coastal regions that have a sensitive environment,” he said.

GenPhar is looking to build a $10 million facility to manufacture its vaccine. The company hasn’t selected land yet, but Dong said he hopes it will be close to the Medical University of South Carolina or Clemson University.

The new vaccine GenPhar researchers are working on would be “multivalent,” meaning it would protect against multiple strains of Ebola and Marburg. The vaccine works by inducing the immune system to attack a benign virus with the same shape as Ebola. “A sheep in the clothing of a wolf,” Dong said.

The lethal and mysterious nature of the virus has translated into big bucks for the entertainment industry, with such hits as the 1995 movie “Outbreak” and Richard Preston’s 1996 best-seller, “The Hot Zone.”

In reality, the virus rarely becomes airborne and usually is confined to periodic outbreaks in Africa, mostly in the Democratic Republic of Congo.

However, with an increasingly globalized society, fears are mounting that Ebola could spread through air travel. Ebola also is viewed as a potential bioterrorism threat because it can be spread so quickly and easily.

“Ebola has the potential to go airborne and be spread like the flu. An airborne strain of Ebola could circle the world in about six or seven weeks,” Peter Jahrling of the Army’s Medical Research Institute of Infectious Diseases said in a statement.

GenPhar receives $30 million each year, about half from the Department of Defense and half from private investors in New York and California. Because of the potential hazard of the virus, much of the research was done at a secure Army facility in Maryland.

If the vaccine is approved, it will be offered to the Army to protect soldiers, and possibly even civilians, from a bioterrorism threat.

A 2002 FDA rule allows certain drugs go to market if there is a great need for the drug and if testing on humans would be impossible without killing someone. The new vaccine still would have to go through trials to determine the best dose, the effect on fetuses and other unanswered questions. But it would not go to a human phase for ethical reasons.

If a disease threat is particularly hazardous, a drug can go on the so-called “fast track,” meaning the application would be reviewed in six months rather than 10.

Other companies also are working in conjunction with the government on Ebola vaccines. The National Institutes of Health did a study based on technology from San Diego-based Vical. The Dutch firm Crucell NV also is working in collaboration with the Army on Ebola vaccine research.

GenPhar was founded in 1999 with about 20 scientists and other workers. Although the Mount Pleasant-based pharmaceutical is small, it has been working in numerous partnerships with other companies and the government to conduct vaccine research. It now is working on vaccines for HIV, avian flu, Spanish flu and other diseases.

Dong, originally from Beijing, moved to the Lowcountry when he founded GenPhar to take advantage of research being done at MUSC and for the quality of life here.

Dong said he hopes the knowledge-based economy in South Carolina will evolve as parts of California have, with “high-technology, high-income, low-environmental-impact development.”

“Once (a company has) a technology, they have a project, and they can have a billion-dollar company,” he said.

GenPhar

Founded: 1999 by Dr. John Dong and Dr. Danher Wang.

Business: Has been focused on developing bio-defense vaccines since 2004.

Headquarters: Mount Pleasant.

Top executive: Dr. John Dong.

Miscellaneous: GenPhar has a joint venture with Tsinghua Yuanxing, a China-based pharmaceutical company, to manufacture and market GenPhar’s hepatitis B, hepatitis C and HIV vaccines in China.

Reach Lucia Walinchus at 937-5921 or [email protected].