HOUSTON & PARIS--(BUSINESS WIRE)--RadioMedix, Inc. and Orano Med, two clinical stage radiopharmaceutical companies, today announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to AlphaMedixTM (212Pb-DOTAMTATE) for the treatment of adult patients with unresectable or metastatic, progressive somatostatin receptor expressing gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who are naïve to peptide receptor radionuclide therapy (PRRT). AlphaMedixTM is a Targeted Alpha Therapy currently in Phase 2 clinical development, which consists of an SSTR-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha particles. Due to their high energy and short path length, alpha emitters enable specific targeting and killing of individual cancer cells, while minimizing toxicity to surrounding healthy tissue. AlphaMedixTM is the first Targeted Alpha Therapy to receive Breakthrough Therapy Designation.

“The FDA's Breakthrough Therapy Designation underscores AlphaMedixTM potential as an innovative treatment that could redefine how patients with neurendocrine tumors are treated. We believe that AlphaMedix™ has potential to demonstrate substantial benefit over currently FDA approved PRRT with beta-particle emitters for patients with metastatic or inoperable SSTR-expressing GEP-NETs. The FDA's decision is a great news for patients suffering from this illness, and an important milestone to expedite the development of this new therapy,” said Ebrahim Delpassand, MD, Chairman and Chief Executive Officer of RadioMedix.

The Breakthrough Therapy Designation is based on the results from phase 1 and the ongoing phase 2 clinical trials that assessed the safety and efficacy of AlphaMedixTM. In the phase 1 study, treatment was well-tolerated, with a response rate (ORR according to RECIST 1.1) of 62.5% for the GEP-NET patients who had never received PRRT with LutatheraTM, which is based on the beta-particle emitter Lutetium-177. In the phase 2 trial, the target response rate has already been achieved ahead of top-line data, expected in mid-2024.
“Receiving FDA Breakthrough Therapy Designation for AlphaMedixTM is a great achievement for everyone involved and confirms the strong interest of the medical community for Targeted Alpha Therapies with lead-212. Based on positive results from our clinical studies to date, we are convinced that Targeted Alpha Therapies, such as AlphaMedixTM, will lead the next generation of radioligand therapies, providing increased cytotoxicity against cancer cells but limited toxicity to adjacent healthy cells. This recognition from the FDA reinforces Orano Med’s commitment to make innovative lead-212-based therapies available to the medical community and patients worldwide,” said Julien Dodet, President and Chief Executive Officer of Orano Med.

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