Flouromannitol PET Imaging Agent (SJ-23-0039)

St. Jude Reference #SJ-23-0039

Description

Infections are responsible for the highest morbidity and the third most deaths among all human diseases worldwide, and drug-resistant infections are predicted to become the leading cause of global death by 2050. Most healthcare-associated infections in the United States arise from several common pathogens, including S. aureus, A. baumannii, P. aeruginosa, and those of the Enterobacteriaceae family. Rising antimicrobial resistance, compounded by a growing population of immunocompromised individuals (HIV/AIDS, chemotherapy, organ transplant, diabetes) creates an annual estimated $28-$45B strain on the U. S. healthcare system.

The most common approach for diagnosing infection involves a cultured sample biopsy to confirm the presence, identity, and drug sensitivity of the bacteria; however, deep-seated infections that cannot be accessed rely upon non-invasive imaging techniques like CT or MRI, based on changes in anatomy or tissue morphology; however, neither can adequately differentiate active infection from sterile inflammatory disease, nor can they diagnose deep-seated infection.

Radiopharmaceuticals have been used to exploit various bacteria-specific signatures such as metabolism, cofactor biosynthesis, and labeled antibiotics. Despite these scientific advances, a dire need persists for imaging agents that meet the challenges of clinical infectious diseases practice, possess broad bacterial strain sensitivity, with desirable pharmacokinetics, and clinical ease of use.

Researchers at St. Jude have developed a diagnostic tool, [18F]fluoromannitol ([18F]FMtl), which is rapidly taken up by gram-positive and gram-negative bacteria at infection sites but not inflammatory  or cancer cells. These characteristics result in a specific PET imaging method for detection of deep-seated and difficult to manage bacterial infections, such as osteomyelitis, prosthetic joint infection, or in patients with sickle cell disease. [18F]fluoromannitol can detect and differentiate infection rapidly and can be produced easily on commercial synthesizers to facilitate user accessibility and mitigate unnecessary antibiotic use.

Keywords

Radiopharmaceuticals, pathogenic bacterial infection, [18F]fluoromannitol ([18F]FMtl), PET imaging, osteomyelitis, prosthetic joint infection, sickle cell disease, antibiotic.

Granted patents or published applications

WO Pending Patent Published as WO 2023/006582.

Related scientific references

Spenser R. Simpson, Alexandria E. Kesterson, Justin H. Wilde, Zoraiz Qureshi, Bijoy Kundu, Mark P. Simons and Kiel D. Neumann, Imaging Diverse Pathogenic Bacteria In Vivo with 18F-Fluoromannitol PET, Journal of Nuclear Medicine May 2023, 64 (5) 809-815; DOI: https://doi.org/10.2967/jnumed.122.264854 

Licensing opportunities

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