"The world is now more vulnerable to smallpox.”

A high-flying biotech outfit with a low-profile La Jolla research outpost has been besieged by critics who say the company's sponsorship of a Canadian horsepox genome project could ultimately lead terrorists to unleash a deadly worldwide smallpox pandemic.

"The synthesis of horsepox virus takes the world one step closer to the reemergence of smallpox as a threat to global health security,” Gregory D. Koblentz, a bio-defense scholar at George Mason University, wrote last spring. He warned that making horsepox from scratch could pave the way for the quick and easy synthesis of variola, the long-eradicated smallpox virus.

"The primary risk posed by this research is that it will open the door to the routine and widespread synthesis of other orthopoxviruses, such as vaccinia, for use in research, public health, and medicine," Koblez continued.

"The normalization and globalization of orthopoxvirus synthesis for these beneficial applications will create a cadre of laboratories and scientists that will also have the capability and expertise to create infectious variola virus from synthetic DNA. "

The controversy began last March when Tonix Pharmaceuticals announced that researchers led by professor David Evans at the University of Alberta had perfected its horsepox-making process for the company.

"Under their research and development agreement, Tonix wholly owns the synthesized [horsepox] virus stock and related sequences," said the company's March 2 news release touting the efficacy of a horsepox-based vaccine it ultimately plans to market for use against smallpox.

Critics say the threat to global health has been made worse by the January 19 publication in the scientific journal Plos One of the step-by-step infectious horsepox recipe developed by the Canadians.

Thomas Inglesby, director of the Center for Health Security at the Johns Hopkins University Bloomberg School of Public Health in Baltimore, Maryland told Science Magazine that publication was "a serious mistake." He added, "The world is now more vulnerable to smallpox.”

Diane DiEuliis, a biosecurity consultant at the National Defense University in Washington DC, told Science, “I would have liked to see an open debate about that at the outset of these experiments.”

According to the account in Science, Tonix funded the Canadian research after a discussion between Evans and Tonix CEO Seth Lederman about the refusal by the U.S. Centers for Disease Control and Prevention to make samples of its closely guarded stockpile of horsepox available to the company.

"I think if you’re really interested in that, I know how to make it,” Evans told Lederman.

Based in New York, Tonix has research and development offices in La Jolla, as well as Dublin, Ireland, and Montreal, Canada, according to federal disclosure records. In addition to synthetic horsepox, the company has been testing TNX-102 SL, a drug to treat post-traumatic stress disorder.

Tonix is currently recruiting experimental subjects for further research on its PTSD drugs through what it bills as the Honor Study, aimed at stricken veterans.

"The study is for an investigational drug that may help improve trauma-related symptoms, including sleep disturbances. There is no cost to participate, and you will also be compensated for your time and travel," says the study website.

Mark Edgar, senior vice president of product development at Tonix, previously held a similar position at La Jolla Pharmaceutical Company. "He has extensive expertise in advancing research-stage pharmaceutical candidates to commercialization, and has authored chemistry, manufacturing and controls (CMC) strategies for numerous drug development programs," per his Tonix website profile.