| Developers: | Radium institute of V.G. Hlopin |
| Date of the premiere of the system: | 2020/10/13 |
| Branches: | Pharmaceutics, medicine, health care |
2020: Development of the production technology of medicine of bichloride of radium-223
On October 13, 2020 it became known, of end of the first stage of the investment project of Radium institute of V.G. Hlopin on creation of radiopharmaceuticals (RFP) on the basis of radium isotopes: radium-223, radium-224, radium-225/actinium-225 for address alpha and nuclide therapy of oncological diseases. This method of radio nuclide therapy is based on delivery of radioactive isotopes using special biological vectors directly to a tumor with the minimum impact of radiation on healthy cells and the patient tissues.
At the first stage of the project scientists and engineers of institute developed the production technology of medicine of bichloride of radium-223 for treatment of bone metastases at a symptomatic metastatic kastratsionno-resistant prostate cancer. The created medicine passed preclinical tests based on Federal State Budgetary Institution RNTsRHT im. ak. A. M. Granova and Federal State Budgetary Institution NMITs onkologii im. N. N. Blochina of the Russian Ministry of Health. Within tests the general security and functional suitability of medicine was studied, a number of researches of its biological activity on different models of tumors of animals is conducted.
Results of tests showed security and high efficiency, the medicine created by scientists, features of kinetics of target accumulation of radionuclide in bone tissues were mentioned, the optimal range of therapeutic influence is estimated, the nature of impact of medicine on tumors of a different stage of formation is revealed. In the nearest future all data of researches will be used for drawing up the registration file on this medicine for providing in the Russian Ministry of Health for the purpose of obtaining permission to carrying out clinical trials.
More than 10 thousand patients annually need Russia in treatment by medicines on the basis of radium-223. The doctor of medical sciences, the director of Federal State Budgetary Institution NMITs onkologii im. N. N. Blochina D.N. Maystrenko notes that "creation of such medicine is extremely important socially important task". In parallel with clinical trials and implementation in medical practice of medicines of radium-223 development of medicines on the basis of actinium-225 which are intended for treatment of a big circle of the oncological diseases incurable for October, 2020 is planned.
Development of medicines and technologies for nuclear medicine – one of priority activities of scientific and medical divisions of Rosatom State Corporation, JSC Nauka i innovatsii and JSC Rusatom Healthcare. The project of Radium institute – one of a number of the projects of this orientation implemented in Rosatom.
Earlier in JSC Rusatom Healthcare (uniform integrator in the field of radiation technologies for medicine and the industry in a circuit of ROSATOM State Corporation) announced start of project implementation of creation of the plant on production of RFP according to the international requirements to production organization and quality control of medicines - GMP (Good Manufacturing Practice). This radio pharmaceutical plant is going to be constructed on the platform of NIFHI of L.Ya. Karpov in Obninsk (Kaluga region). The plant will produce targetny radiopharmaceuticals on the basis of lutetium-177, actinium-225 and radium-223[1].
Notes
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