ProThera Biologics Awarded $1.95-Million NIH Grant

ProThera Biologics and Women & Infants Hospital to Use Funding to Study Treatment for Infant Brain Injury

Providence, R.I., June 26, 2017 – ProThera Biologics today announced that it has been awarded a $1.95-million Phase II Small Business Innovation Research (SBIR) grant by the National Institutes of Health (NIH) to study the potential of Inter-Alpha Inhibitor Proteins (IAIP) to prevent and treat neonatal hypoxic ischemic brain injury.  

ProThera collaborated with Women & Infants Hospital (WIH) on the pilot phase of the study, which was supported by a 2010 research grant from the Rhode Island Science and Technology Advisory Council (STAC). Based on the success achieved during Phase I, ProThera was issued the second round of SBIR grant funding. ProThera will work once again with Dr. Barbara Stonestreet, M.D., a neonatal-perinatal specialist at WIH and professor of pediatrics at the Warren Alpert School of Medicine at Brown University, and Xiaodi Chen, M.D., Ph.D., a key member of her team, to conduct the Phase II study.

ProThera is a biotherapeutics company developing IAIP for the treatment of acute inflammatory disease, including severe community-acquired pneumonia and neuro-inflammatory diseases.  IAIP are naturally occurring proteins that circulate in the blood and play an essential role in human health by modulating inflammation, preventing damage and repairing injured tissues. They exert their anti-inflammatory effects through multiple mechanisms and have a broad range of potential uses. Since inception, ProThera has invested an aggregate of $12 million in the preclinical development of IAIP, funded primarily from peer-reviewed grants awarded by the NIH.

Hypoxic ischemic (HI) injury, which occurs in infants when blood flow to the brain is reduced, is the one of leading causes of infant mortality and long-term neurologic disability.  Inflammation of the brain is a major contributor to the disease, and ProThera and WIH researchers have determined that IAIP levels play a part in the inflammatory process. In animal models, IAIP therapy has been shown to reduce this inflammation and dramatically improve outcomes. ProThera’s goal is to provide the first drug therapy to address the inflammatory process in neonatal HI brain injury, leading to improved survival and a reduction in the many detrimental effects of this disease. 

“Hypoxic ischemia brain injury is one of the most significant challenges faced by infants today, and we have great hopes that IAIP can have significant benefit in treating and preventing the effects of this terrible disease,” said Dr. Stonestreet. “So far, we have seen extremely promising results with this drug, and this new grant will allow us to more fully understand and explore the promise of IAIP.”

“We are delighted to be working with Dr. Stonestreet on this critical program,” said Dr. Yow-Pin Lim, founder and CEO of ProThera Biologics, who serves as Principal Investigator in this NIH supported project. “Her extensive knowledge is key to our program’s success. Our goals in working with her are to demonstrate the value of IAIP, move IAIP into clinical testing, and ultimately make IAIP a key part of the limited therapeutic tools available today to treat these delicate and important patients.”

About ProThera Biologics

ProThera Biologics was founded to focus on the critical role of Inter-alpha Inhibitor Proteins (IAIP) for treating life-threatening inflammatory diseases. Based on research that originated in the laboratories of the co-founders, Dr. Yow-Pin Lim, and Douglas C. Hixson, Ph.D., at Lifespan’s Rhode Island Hospital, ProThera Biologics has pioneered the usage of IAIP to fight acute inflammation in critical disease. Today, the company has expanded its executive team to include Denice Spero, Ph.D., the president and chief business officer, and Richard Andrews, the chief operating officer, and is focused on moving into the clinic with IAIP to treat acute inflammatory diseases such as severe community-acquired pneumonia and has a pipeline of indication areas, including neonatal brain injury and ischemic stroke.

In 2015, ProThera Biologics formed a strategic alliance with ProMetic Life Sciences (TSX: PLI), a biopharmaceutical company with globally recognized expertise in bioseparation technology. ProMetic will manufacture IAIP using its own advanced and proprietary affinity separation technology. The ProMetic alliance has been a key to accelerating ProThera’s progress to the clinic.

About Women & Infants Hospital

Women & Infants Hospital of Rhode Island, a Care New England hospital, is one of the nation’s leading specialty hospitals for women and newborns. A major teaching affiliate of The Warren Alpert Medical School of Brown University for obstetrics, gynecology and newborn pediatrics, as well as a number of specialized programs in women’s medicine, Women & Infants is the 9th largest stand-alone obstetrical service in the country and the largest in New England with approximately 8,500 deliveries per year. A Designated Baby-Friendly® USA hospital, U.S.News & World Report 2014-15 Best Children’s Hospital in Neonatology and a 2014 Leapfrog Top Hospital, in 2009 Women & Infants opened what was at the time the country’s largest, single-family room neonatal intensive care unit. 

Women & Infants and Brown offer fellowship programs in gynecologic oncology, maternal-fetal medicine, urogynecology and reconstructive pelvic surgery, neonatal-perinatal medicine, pediatric and perinatal pathology, gynecologic pathology and cytopathology, and reproductive endocrinology and infertility. It is home to the nation’s first mother-baby perinatal psychiatric partial hospital, as well as the nation’s only fellowship program in obstetric medicine.

Women & Infants has been designated as a Breast Imaging Center of Excellence by the American College of Radiography; a Center of Excellence in Minimally Invasive Gynecology; a Center of Biomedical Research Excellence by the National Institutes of Health (NIH); and a Neonatal Resource Services Center of Excellence. It is one of the largest and most prestigious research facilities in high risk and normal obstetrics, gynecology and newborn pediatrics in the nation, and is a member of the National Cancer Institute’s Gynecologic Oncology Group and the Pelvic Floor Disorders Network.