Nuclear and Radiopharmacies, Gemelli towards Phase 1 accreditation – Health and Wellbeing

by times news cr

2024-03-21 21:55:27

(ANSA) – ROME, MARCH 19 – The new frontier of nuclear medicine combines diagnostics and therapy with radiopharmaceuticals. It was discussed at the Gemelli Polyclinic in Rome during the international seminar ‘Radiopharmacy: the Next One’. At the center of the debate is the future phase I accreditation of the Nuclear Medicine and Radiopharmacies of the Gemelli Irccs Foundation.
“Conducting a Phase I study – explains Gennaro Daniele, program director and Phase I Uoc of Fondazione Policlinico Gemelli Irccs and contract professor at the Università Cattolica del Sacro Cuore, Rome campus – means dealing with research at an earlier and more to carry out so-called ‘first-in-human’ clinical studies. The phase I program has already been successfully active for some years at the Foundation for both oncological and non-oncological studies”. Among the new applications in diagnostics, Salvatore Annunziata, head of the GSTeP Radiopharmacy facility, announces for the next few months the launch of “innovative isotope tests such as 89Zr and 64Cu, which can be conjugated with monoclonal antibodies, for the first time in a radiopharmacy Italian hospital. In the case of anti-PD-L1 antibodies – he continues – its expression could be evaluated in multiple sites, while today it is evaluated on a single lesion. This is why we speak of ‘immuno-Pet’, a possible pre-imaging -treatment, which would allow better identification of PD-L1 expression, not only at the biopsy site but in all disease sites”. The Phase 1 studies will also concern the therapeutic field of Nuclear Medicine, as explained by Alessandro Giordano, director of the Uoc Nuclear Medicine of Fondazione Policlinico Gemelli Irccs and Professor of Nuclear Medicine at the Catholic University of the Sacred Heart. “We hope to be able to carry out first-in-human studies also with therapeutic radiopharmaceuticals in order to create a complete ‘theranostic’ path: from diagnosis to therapy using the same molecule (ligand) but labeled with different radionuclides”. The activation of phase I constitutes “a step to broaden the opportunities in the national and international research panorama – concludes Giovanni Scambia, Scientific Director of Fondazione Policlinico Gemelli IRCCS and Professor of Gynecology and Obstetrics at the Catholic University of the Sacred Heart – That of Gemelli , is one of the few Italian GMP-like radiopharmacies for research on experimental PET radiopharmaceuticals”. (HANDLE).


2024-03-21 21:55:27

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