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Preclinical areas of interest

Noveome’s preclinical programs will help demonstrate the significant platform capability of ST266.

Chronic Traumatic Encephalopathy (CTE)

CTE is a progressive degenerative disease of the brain linked to repetitive head trauma. It is most frequently seen in athletes and combat soldiers. A recent study published in the Journal of the American Medical Association (JAMA) found CTE in 99% of brains obtained from autopsies of National Football League (NFL) players, as well as 91% of those from college football players and 21% of those from high school football players (Mez, et al. 2017). It has also been shown that CTE involves formation of extensive tau aggregate deposits, the same deposits seen in other neurodegenerative conditions such as Alzheimer’s disease.

Preclinical studies have shown that ST266 attenuates the neurodegeneration and inflammation of penetrating ballistic brain injuries, a model of gunshot wounds and other open-head traumatic brain injuries (Deng-Bryant, et al. 2015). As many of the same pathways are involved in closed-head traumatic brain injuries, it is hoped these findings will translate into similar positive effects in CTE.

Emphysema

Emphysema is a chronic disease involving the gradual damage of lung tissue—specifically the thinning and destruction of the alveoli—usually caused by smoking or significant exposure to air pollution. The estimated prevalence of emphysema in the U.S. alone is 3.5 million (source: www.cdc.gov). Currently, there are no approved drugs that can protect and rebuild the damaged lung tissue that occurs with emphysema.

In a preclinical animal model of emphysema, ST266 has been shown to restore lung tissue. Additional studies in this arena are in progress.

Necrotizing Enterocolitis (NEC)

NEC is a leading cause of death in infants born prematurely (before 37 weeks of pregnancy) or born with a low birth weight (less than 5.5 pounds). NEC may be linked to a reduced exposure to amniotic fluid as a result of premature birth (Hackam, D.J. and Sodhi, C.P. (2018). There is no cure for this disease and there has been no change in its mortality rate in 30 years. What’s more, the population most at risk for NEC continues to increase, as technological advances have improved the neonatal care of very low birth weight infants.

Approximately 480,000 infants are born preterm each year in the U.S.—all at increased risk for NEC. The percentage of very low birth weight infants who develop NEC remains steady at about 7% (source: www.nichd.nih.gov).

Because ST266 is made from selected and cultured amnion epithelial cells, it may provide many of the same benefits as amniotic fluid. Preclinical studies are underway to investigate the potential role of ST266 in helping prevent the onset of NEC and/or accelerate its recovery.