Houston (TX U.S.), Courbevoie (France), November 13th, 2018. 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 AlphaMedixTM for the treatment of neuroendocrine tumors (NETs). AlphaMedixTM 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 AlphaMedixTM 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 AlphaMedixTM”, echoed Dr. Izabela Tworowska, Ph.D., CSO of RadioMedix.
The mechanism of action of AlphaMedixTM 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 AlphaMedixTM 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 AlphaMedixTM, 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 AlphaMedixTM 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.
About Neuroendocrine Tumors
Neuroendocrine tumors (NETs) are a heterogeneous group of rare neoplasms that originate from neuroendocrine cells. These neoplasms occur mostly in the gastrointestinal tract and pancreas, but can also occur in other tissues including thymus, lung, and other uncommon sites such as ovaries, heart, and prostate. Most NETs strongly express somatostatin receptors (SSTRs).
AlphaMedixTM is a radiolabeled SSTR-targeting therapeutic investigational drug for the treatment of NETs patients. The product consists of SSTR-targeting peptide complex radiolabeled with 212Pb and serve as an in vivo generator of alpha-emitting particles. 212Pb isotope is particularly suitable for SSTR therapy applications based upon its half-life, energy and decay properties.
More about RadioMedix
RadioMedix, Inc. is a clinical stage biotechnology company, based in Houston, Texas, focused on innovative targeted radiopharmaceuticals for the diagnosis, monitoring, and therapy of cancer. The company is commercializing PET imaging and targeted radiotherapies using alpha- and beta-labeled drug products. RadioMedix has a strong clinical record serving as a sponsor and collaborator of multiple clinical studies. For more information visit us at www.radiomedix.com.
More about Orano Med
Orano Med (formerly AREVA Med) is a nuclear biotech company developing innovative therapies in oncology. Orano Med has developed new processes for producing lead-212 (212Pb), a rare radioactive isotope used in Targeted Alpha Therapy (TAT), an innovative and promising approach of nuclear medicine that recognizes and destroys cancer cells while limiting the impact on nearby healthy cells. With its partners, Orano Med pursues the development of effective therapies to address patients’ needs. More information about Orano Med: www.oranomed.com. Follow @OranoMedMed on Twitter.
Media contact: Izabela Tworowska Ph.D.,CSO