RadioMedix and Orano Med receive FDA Orphan Drug Designation for AlphaMedix(TM) for the treatment of neuroendocrine tumors

Houston, Texas (USA) and Courbevoie (France)

RadioMedix Inc. (a Texas-based clinical stage biotechnology company) and Orano Med (a nuclear biotechnology company) announced today that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AlphaMedix^TM for the treatment of neuroendocrine tumors (NETs).  AlphaMedix^TM is a ²¹²Pb-labeled somatostatin analogue used for the targeted alpha therapy (TAT) of neuroendocrine tumors (NETs).

“TAT has brought new hope to our patients with cancer, and the range of available therapies in this area will only increase in the near future. We are pleased to conduct the first TAT clinical trial in the U.S. for neuroendocrine cancers, with the aim of registration of the drug,” said Dr. Ebrahim S. Delpassand, CEO of RadioMedix and Medical Director of the clinical studies. “We are hoping that AlphaMedix^TM will provide a breakthrough therapy that will benefit our patients soon,” added Dr. Delpassand. “We are excited about the progress of our dose escalation studies of AlphaMedix^TM”, echoed Dr. Izabela Tworowska, Ph.D., CSO of RadioMedix.

The mechanism of action of AlphaMedix^TM relies on the delivery of a cytotoxic load of alpha-emitters to SSTR-overexpressing neuroendocrine tumors. Alpha- emitters are highly energetic radioactive particles that can cause irreversible damage to the cancer cells. RadioMedix and Orano Med initiated the Phase 1 clinical trial of the safety and preliminary efficacy of AlphaMedix^TM in February of 2018 (NCT03466216); the study is currently recruiting patients at the Excel Diagnostics and Nuclear Oncology Center in Houston, TX U.S.

“FDA’s decision to grant Orphan drug Designation is an important regulatory milestone for AlphaMedix^TM, a key program in our pipeline of ²¹²Pb-labeled compounds,” said Julien Dodet, CEO of Orano Med. “We believe TAT with ²¹²Pb represents a promising new approach and that AlphaMedix^TM has the potential to have a meaningful impact on patients”.

Orphan designation is granted by the FDA Office of Orphan Products Development to advance the evaluation and development of safe and effective therapies for the treatment of rare diseases or conditions affecting fewer than 200,000 people in the U.S. The designation provides certain benefits to drug developers such as seven-year marketing exclusivity upon FDA approval, tax credits for qualified clinical testing or prescription drug user fee exemption.