By GREGORY ZELLER //
With a little help from the besieged National Institutes of Health, a pillar of Long Island-based scientific research and one of its shining biotech spinoffs are taking the fight to a modern-medicine scourge responsible for some 500,000 U.S. deaths each year.
The Feinstein Institute for Medical Research, the R&D division of the Northwell Health system, and Manhasset-based TheraSource LLC, a circa-2004 biopharma spun out of the Feinstein Institute, announced this week that they’ve received a Phase I Small Business Technology Transfer grant from the NIH’s National Institute of General Medical Sciences.
With its ability to support laboratory research not yet crippled by a proposed 2018 federal budget that cuts nearly $6 billion from the NIH budget, the NIGMS – which supports basic research that increases understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment and prevention – is still awarding research grants. This one will promote efforts to create a new pharmaceutical treatment for sepsis, a life-threatening immune system reaction to infection.
Sepsis occurs when chemicals released into the bloodstream to fight an infection trigger inflammatory responses throughout the body. The inflammation can damage multiple organ systems and cause them to fail; if septic shock occurs, blood pressure drops dramatically and death often follows.
While anyone can develop sepsis, it’s most common – and “most dangerous,” according to the Minnesota-based Mayo Clinic – in older adults or patients with weakened immune systems. Contemporary treatments usually involve antibiotics and large amounts of intravenous fluids.
Sepsis commonly presents symptoms such as fever, swelling, pain, accelerated heart rate, breathing difficulties and disorientation. It affects more than 1 million Americans annually and about half of them die, according to the NIH.
The Feinstein Institute is already working on a therapy that, if successful, could reduce tissue damage and organ deterioration associated with sepsis – and ultimately save lives, according to the Feinstein Institute.
The study – led by Max Brenner, TheraSource’s director of drug discovery, and Haichao Wang, director of the Feinstein Institute’s Laboratory of Emergency Medicine – will focus on TSA521, a compound Wang derived from tanshinone, an herbal component of extracts from Salvia miltiorrhiza (a.k.a. red sage), a root widely used in traditional Chinese medicines.
Wang and his research team previously found that chemical derivatives of tanshinone “suppressed the release of damage-causing molecules in sepsis and improved survival rates in preclinical models of lethal sepsis,” according to the Feinstein Institute.
The new study will include two phases. The first will look to determine TSA521’s optimal dose to treat sepsis. The second will examine TSA521’s safety and pharmacological parameters.
The two phases mark a final step, of sorts, before TSA521 is greenlighted for human clinical trials, according to the Feinstein Institute – or, as Wang said Monday, “a first step in the process of developing TSA521 towards clinical use.”
“We are pleased to collaborate with TheraSource in an effort to develop a potential new therapy for patients suffering from sepsis, building on the work of other accomplished Feinstein Institute investigators,” Wang added. “Our research team is grateful for the NIH’s support.”
The sepsis-focused research grant comes at a time when federal funding for pure laboratory research is under heavy fire. President Donald Trump’s first federal budget proposal, which was released in March and targets the 2018 fiscal year, cuts 18 percent from the NIH’s overall budget – a serious threat to the NIGMS’s ability to continue funding research efforts like the TheraSource sepsis study.
The new Small Business Technology Transfer grant is not the first for TheraSource. In 2016, the biopharma firm snagged a $3 million award from the NIH’s National Institute of Allergy and Infectious Diseases to develop innovative treatments to battle complications from unintentional radiation exposure.
Brenner said TheraSource – which boasts an intellectual property portfolio containing 14 U.S. patents – was “honored to be selected” by the NIH for another Phase I SBTT grant.
“The highly competitive Small Business Technology Transfer program provides critical funding to emerging bioscience companies to pursue innovative research with the potential to impact human health and society,” Brenner said in a statement. “Based on our preliminary studies, we feel that TSA521 has the potential to be developed as an effective therapeutic agent to treat patients with sepsis and septic shock.”