NIH gives startup $2.8M for sepsis, anthrax trials

Every year, across the United States, nearly 800,000 people develop severe sepsis, a life-threatening condition in which the body is overwhelmed by infection, and the organs begin to shut down. About 30 to 50 percent of patients who go into severe sepsis die.

To save patients, hospitals have to provide very intensive, costly care; in the United States alone, sepsis is estimated to cost $17 billion per year.

So if someone could treat sepsis more effectively – or even better, prevent it by identifying patients at risk and protecting them – can you imagine the impact that would make?

The scientists at East Providence-based ProThera Biologics think they have what it takes. And last week the company, a Brown University research spinoff backed by the Slater Technology Fund, announced it has been awarded $1.8 million from the National Institutes of Health to put its therapies to the test at local hospitals.

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In addition, ProThera is getting $1 million from the NIH’s National Institute of Allergy and Infectious Diseases to support development of a separate therapy for people who have been exposed to anthrax.

Anthrax is considered one of the greatest bioterror threats due to its ease of transmission, high mortality and morbidity rate, potential for public panic, and special measures required to avoid an epidemic. In 2001, a deliberate attack through the mail killed five Americans.

Both the anthrax and the sepsis therapy are based on biomedical research by Dr. Yow-Pin Lim, the president and chief scientific officer of ProThera Biologics and a research oncologist at Brown Medical School. Lim is recognized as a pioneer in the study of natural proteins known as “inter-alpha inhibitors.”

In 2001, Lim and fellow Brown researcher Douglas C. Hixson started ProThera to translate the science into therapies. Since then, they’ve developed several potential applications for diagnostics, treatments, and hybrid “theranostics” that could identify at-risk patients and give them personalized therapies.

“Our goal is to develop products that will address major unmet medical needs and significant markets,” Lim said in a news release. “I am extremely excited and proud that the NIH has recognized the scientific value and commercialization potential of our translational and clinical research.”

ProThera is part of Slater’s portfolio, and Richard G. Horan, managing director of the state-financed technology fund, praised the company for “making great progress” with a “traditional biotech strategy.”

“Focusing on the clinical development of a particular class of therapeutic protein, the company has leveraged a limited equity capitalization with significant federal grant funding,” Horan said in the news release. “In addition, the company has developed proprietary biomarkers to stratify the patient populations to be treated, which is an emerging paradigm becoming more widely practiced among biopharmaceutical companies. We’re very excited about the progress being made and look forward to working with the company in completing a next round of financing.”

The sepsis grant is a Phase II Small Business Innovation Research award. Lim is collaborating with Dr. Steven M. Opal, a Brown Medical School professor, who will direct clinical trials in septic patients at Memorial Hospital of Rhode Island, The Miriam Hospital of Rhode Island and Rhode Island Hospital.

The anthrax grant is a two-year Phase I Small Business Technology Transfer Research grant. ProThera’s technology focuses on blocking the harmful anthrax toxin and preventing the severe, usually fatal inflammation that follows – a complication similar to what occurs in sepsis. That approach, Slater said, gives ProThera “a distinct competitive advantage” against those companies targeting the anthrax bacteria itself.

Lim is also collaborating with Opal on that project, working in this case at the Center for Biodefense and Emerging Pathogens at Memorial Hospital.

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