CereMark Pharma LLC entered into a supply agreement with SpectronRx for the production of [F-18] Flornaptitril, an investigational new positron emission tomography (PET) imaging radiopharmaceutical being studied in the management of neurodegenerative diseases including the development and progression of Alzheimer’s Disease (AD), Chronic Traumatic Encephalopathy (CTE), and other diseases associated with cognitive impairment. 

CereMark’s CEO Henry Chilton said, “We are pleased to be working with SpectronRx for the manufacture, supply, and distribution of [F-18]Flornaptitril. SpectronRx is a leader in the cyclotron-assisted production and clinical trial support of investigational new radiopharmaceuticals and is globally respected for its clinical development capabilities and manufacturing services. Our engagement of SpectronRx is another significant milestone towards fulfilling the regulatory requirements for the development and approval of this unique, dual-targeting, short-lived PET imaging biomarker.”

Anwer Rizvi, president of SpectronRx said, “SpectronRx is delighted to offer its services to support the manufacturing and distribution of [F-18]Flornaptitril for CereMark’s clinical trials and to create the necessary radiochemistry synthesis platform that could be used in commercializing Flornaptitril when approved by FDA.”

Previous clinical studies with [F-18] Flornaptitril have demonstrated unique imaging abilities – as seen on PET scans – to simultaneously detect both beta-amyloid plaques and tau macroaggregates.

SpectronRx will manufacture [F-18] Flornaptitril for CereMark using the patented radiochemical synthetic technique held exclusively by CereMark under license from UCLA.  CereMark plans to use [F-18] Flornaptitril manufactured by SpectronRx in its Phase 3 multi-site clinical study planned to start later this year.