The development of an innovative imaging agent capable of non-invasively detecting vulnerable plaques is a major objective of research in cardiovascular pathology. Such a tool would allow for better identification of patients at risk of acute events. We showed that 99mTechnetium (99mTc)-labeled fucoidan was able to target P-selectine expressed by activated platelets in vitro in humans and in vivo in a model of abdominal aortic aorta thrombus and endocarditic vegetations in rats.
One of the objectives of the Nanoathero program is the clinical translation of the 99mTc-fucoidan. As a first step, we will assess the safety, biodistribution and dosimetry of this new radiopharmaceutical in humans.

开始日期2018-02-01

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

100 项与 99mTc-Fucoidan 相关的临床结果

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100 项与 99mTc-Fucoidan 相关的转化医学

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100 项与 99mTc-Fucoidan 相关的专利（医药）

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项与 99mTc-Fucoidan 相关的文献（医药）

Marine Drugs2区 · 医学

Pharmaceutical Development and Safety Evaluation of a GMP-Grade Fucoidan for Molecular Diagnosis of Cardiovascular Diseases

2区 · 医学

ArticleOA

作者: Chollet, Lucas ; Zheng, Kang H ; Aid-Launais, Rachida ; Bonafé, Roberta ; Cabella, Claudia ; Rolland, Lydia ; Letourneur, Didier ; Rouzet, François ; Bussi, Simona ; Chaubet, Frédéric ; Chahid, Youssef ; Chauvierre, Cédric ; Fülöp, Tamas ; Szebeni, Janos ; Rossi, Silvia ; Dézsi, Laszlo ; Stroes, Erik S G ; Le Guludec, Dominique ; Maire, Murielle ; Aerts, Joël

The adhesion molecule P-selectin is present on the cell surface of both activated endothelium and activated platelets. The present study describes the pharmaceutical development, safety evaluation, and preclinical efficacy of a micro-dosed radiotracer. The macromolecular nanoscale assembly consisted of a natural compound made of a sulfated fucose-rich polysaccharides (fucoidan) and a radionuclide (technetium-99m) for the detection of P-selectin expression in cardiovascular diseases. After extraction and fractionation from brown seaweeds, the good manufacturing practice (GMP) production of a low molecular weight (LMW) fucoidan of 7 kDa was achieved and full physicochemical characterization was performed. The regulatory toxicology study in rats of the GMP batch of LMW fucoidan revealed no adverse effects up to 400 μg/kg (×500 higher than the expected human dose) and pseudoallergy was not seen as well. In a myocardial ischemia-reperfusion model in rats, the GMP-grade LMW fucoidan labeled with technetium-99m detected P-selectin upregulation in vivo. The present study supports the potential of using 99mTc-fucoidan as an imaging agent to detect activated endothelium in humans.

100 项与 99mTc-Fucoidan 相关的药物交易

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