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

ST266 has been shown to be safe and can be delivered via diverse routes of administration: topical (dermal, oral mucosa, ocular), parenteral, intranasal, intravenous, oral gavage, intracameral. In addition, its anti-inflammatory, neuroprotective, and other properties suggest that it may be useful for the treatment of a wide range of indications beyond the eye.

Chronic Traumatic Encephalopathy (CTE)

CTE is a progressive degenerative disease of the brain linked to repetitive head trauma. It is 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).

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). 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. 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. ST266 can be given by intranasal delivery for CTE and all other central nervous system (CNS) indications. Noveome sponsored studies in CNS received support from the Department of Defense and the Commonwealth of Pennsylvania.

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 no change in its mortality rate in 30 years. Moreover, the population at greatest 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 NEC and/or accelerate its recovery. Noveome sponsored studies in NEC received support from the Commonwealth of Pennsylvania.

Radiation Burns

Radiation burns of the skin are a common side effect of external beam radiotherapy for the treatment of cancer. These dermal burns are often severe, particularly when treating head-and-neck cancer or pelvic cancer, such that radiation treatments are sometimes interrupted to allow the patient time to recover.

When radiation therapy is interrupted, especially in head-and-neck cancer, the mortality may go up. There is no ideal preventive therapy to reduce the severity of radiation burns of the skin. ST266 has been shown to be anti-inflammatory and offers the possibility of reducing the severity of radiation burns, thereby lessening the pain, and thus improving survival by preventing the need for a break in the treatment regimen. Noveome sponsored studies in radiation burns received support from the U.S. Department of Defense and the Commonwealth of Pennsylvania.

Trigeminal Neuralgia

Trigeminal Neuralgia is a rare disease of the fifth cranial nerve commonly seen in people over 50 years of age. Patients have severe pain in their face triggered by minor events such as brushing their teeth and lasting several minutes to several hours. The pain is sometimes on only one side. It interferes with activities of daily living because of fear of triggering an attack.

Treatments include surgery or medications such as anticonvulsants or antidepressants. Noveome can deliver its platform biologic ST266 intranasally to the trigeminal nerve. Noveome sponsored studies in Trigeminal Neuralgia will receive support from the Commonwealth of Pennsylvania.

Periodontal Disease

Severe periodontitis is a problem that affects 3.5 million Americans and lacks adequate therapy. Periodontitis is characterized by an acute inflammatory reaction that, if unresolved with failure of tissue to return to homeostasis, results in tissue destruction and chronic inflammation. Severe periodontitis remains the primary cause of tooth loss. Resolution of inflammation in periodontitis with ST266 may reduce injury, promote healing, and restore tissue homeostasis.

Preclinical experiments have shown that ST266 reduces inflammatory cytokines, restores lost bone and resolves inflammatory infiltrates. In a Phase 2 clinical study sponsored by Noveome, ST266 resulted in a statistically significant reduction in inflammation by day 15 and was shown to be safe and well tolerated. Noveome sponsored studies in periodontal disease received support from the U.S. Department of Defense.

Polytrauma

“Polytrauma” and “multiple trauma” are terms often used to describe the injuries to a person from violence, motor vehicle wrecks, falls, wars, or other accidents. In many cases there is also loss of blood. The organs injured are commonly skin, bones, brain, and internal organs of the chest and/or abdomen. At a time when deaths from cancer or heart disease are decreasing, death from polytrauma is increasing. Alcohol is often a factor in these accidents and deaths. Each year, over 200,000 people die from multiple trauma with many more people injured. Deaths can be reduced by life-saving measures including early diagnosis, resuscitation, control of bleeding, and treatment of the injuries.

Early in the course of multiple injuries, there is an inflammatory reaction which can lead to multi-organ failure, sepsis, and death. Preclinical studies of ST266 given systemically in polytrauma have shown the potential benefits of controlling inflammation and resuscitating damaged tissues in the early period after an injury. Noveome sponsored studies in polytrauma received support from the Commonwealth of Pennsylvania.