Health: American-Italian alliance to produce radiopharmaceuticals for cancer diagnosis and treatment

On the left, ENEA President Federico Testa with Louis Centofanti, Perma-Fix founder

The agreement has been signed in Rome by the founder of Perma-Fix Environmental Services, Louis Centofanti, and Enea President Federico Testa.

The Agreement foresees the production of  Technetium (^99mTc), one of the most widely used medical isotopes, utilizing the ENEA TRIGA RC-1 research reactor made available by ENEA and a special process ^[1] developed by Perma-Fix Medical, specialized in the pharmeceutical sector.

The Italian American alliance has strategic importance since it will allow to address the forthcoming shortage of  Technetium due to the closure of the Canadian National Research Universal Reactor^[2], today leading producer of the isotope globally.

After careful inspections, Technetium generators will be supplied to nuclear medicine centers; the quantities produced by TRIGA in the Casaccia ENEA Center will be sufficient to supply a large percentage of the national requirements already in the early stages of production.

Under the Agreement, Perma-Fix medical will support ENEA in the national and international authorizational procedures to obtain  accreditation under “Good Manufactoring Procedures”.

“The innovative method for producing Technitium, developed and patented by Perma-fix for medical diagnosis tests - Perma-Flex founder Louis Centofanti explained - is expected to solve worldwide shortages of Technetium as it is less expensive, and does not require the use of government-subsidized, weapons-grade materials. Developed to increase physical and radiological safety of materials, this process, encompassing the full production cycle, can be easily deployed around the world since it can be used in standard research and commercial reactors, eliminating the need for special purpose reactors and  allowing to stabilize global Technetium supply, allowing for local production”.

“With this agreement - ENEA President Federico Testa said - ENEA intends to put at the service of the Country the skills,  resources and infrastructures acquired in the nuclear sector since the 1950’s into new areas such as health care. The goal is to build a unique center of excellence in Italy, aiming at the study of new radioisotopes and the production of a new generation of pharmaceuticals, a sector arising growing interest at the national and international levels”.

In order to gather high level resources and competences and develop an efficient production line of radiopharmaceuticals, ENEA is in the process of finalising national and international agreements with public and private subjects,  also through the involvement of national stakeholders in the radiopharmaceutical sector: among the international collaborations is that with UJV Rez, the ENEA counterpart in the Czech Republic, for the production of Technetium.

At the national level, bilateral agreements with ACOM Srl and IBA Molecular Italy Srl, aiming at the study and production of new radioisotopes for theranostic- an emerging discipline which foresees its use for the diagnosis and treatment of cancer procedures, so for both the early detection of tumor cells and their  eradication- are in the process of being finalised.

ENEA has estimated the market value of nuclear medicine products in Italy to be approximately 37 million euro, and that of contrast media for radiology procedures  approximately 100 million euro.

Furthermore, according to the “White Book” of the Italian Nuclear Medicine and Molecular Imaging Association (AIMN), in centraly Italy alone 85 nuclear medicine structures are present, equal to 33%  of the national total, for a resident population of over 14 million inhabitants^[3]. The Lazio Region in particular,  counts over 45 nuclear medicine centers, mostly near Rome.

For more information please contact:

Alessandro Dodaro, ENEA – Head Division “Technologies, Facilities and Materials for Nuclear Fission”, alessandro.dodaro@enea.it

[1] A process utilizing a specialized microporous resin for the separation of Technetium

[2] The Canadian reactor covered 40% of the global demand for Technetium  (^99mTc)

[3] http://www.enea.it/it/seguici/pubblicazioni/EAI/anno-2017/n-3-luglio-settembre-2017/il-progetto-moly-una-via-italiana-per-la-produzione-del-radiofarmaco-99mtc