Radiomedix and Orano Med Announce the Initiation of the Phase II Multi-Center Clinical Trial of Alphamedix™
Posted by RadioMedix . on
Houston, TX and Plano, TX, Jan. 03, 2022
RadioMedix and Orano Med are pleased to announce the initiation of the Phase II clinical trial of AlphaMedix™ with the treatment of the first patient on December 21st, 2021. This trial will evaluate the safety and effectiveness of 212Pb-DOTAMTATE (AlphaMedix™) in Peptide Receptor Radionuclide Therapy (PRRT) of naive patients with somatostatin receptor-expressing neuroendocrine tumors (NET).
“The initiation of the Phase II trial is a significant milestone in the clinical development of our innovative targeted alpha-emitter radiotherapy and brings us one step closer to having this drug available for our patients”, said Ebrahim Delpassand, MD, Chairman and Chief Executive Officer of RadioMedix. “Targeted alpha therapy (TAT) with 212Pb-DOTAMTATE has been shown to be well-tolerated and preliminary efficacy results are highly promising. If these results are confirmed in the Phase II trial, it could potentially provide substantial benefit over currently FDA approved therapies for patients with metastatic or inoperable SSTR-expressing NETs regardless of the grade and location of the primary tumor”, added Dr. Delpassand.
“This milestone highlights the strength of collaboration between RadioMedix and Orano Med teams dedicated to making targeted alpha-emitter therapy with AlphaMedix™ available to NET patients”, said Dr. Izabela Tworowska, Chief Scientific Officer of RadioMedix.
Additionally, Julien Dodet, President and Chief Executive Officer of Orano Med, noted “We are excited to have this Phase II trial underway and we are confident that this trial will confirm the very promising results from Phase I. It would be yet another demonstration of the interest of the combination of 212Pb and fast-PK targeting agents like DOTAMTATE. This reinforces Orano Med’s commitment to make innovative 212Pb-based therapies available to the medical community and patients worldwide.”
The Phase II trial will enroll a total of 34 patients with histologically confirmed NETs and positive somatostatin analogue imaging who have not received prior PRRT. Treatment will consist of up to 4 cycles of AlphaMedix™. We would like to thank Dr. Rodolfo Nunez, principal investigator, and the research team at Excel Diagnostics and Nuclear Oncology Center in Houston for enrolling our first patient in Phase II”, added Jason Hurt, MD, Chief Medical Officer of Orano Med.
ABOUT RADIOMEDIX
RadioMedix, Inc. is a clinical-stage biotechnology company, and sponsor of the AlphaMedix™ trial, based in Houston and Humble, Texas. The company is focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. RadioMedix is developing radiopharmaceuticals for PET imaging and therapy (alpha- and beta-labeled agents). The company established contract service facilities for academic and industrial partners including a drug discovery center for the early probe development, a pre-clinical core facility for in vitro and in vivo evaluation of radiopharmaceuticals, and cGMP and analytical suite for Phase I-III clinical trials, and the large-scale post-approval commercial manufacturing facility, the Spica Center. To learn more, visit www.radiomedix.com
ABOUT ORANO MED
Orano Med is a clinical-stage biotechnology company with the ambition to develop a new generation of targeted therapies against cancer using the unique properties of lead-212 (212Pb), a rare alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha-Emmiter Therapy (TAT). The company develops several treatments using 212Pb combined with various targeting agents; it has formed multiple collaborations with prestigious institutions and biopharmaceutical companies. Orano Med has 212Pb manufacturing facilities, laboratories, and R&D centers in France and in the US and is currently investing to further expand its GMP-manufacturing capacities for 212Pb radiolabeled pharmaceuticals in North America and Europe. To learn more, visit www.oranomed.com.
ABOUT ALPHAMEDIX TM
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 that serves 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.
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 the thymus, lung, and other uncommon sites such as ovaries, heart, and prostate. Most NETs strongly express somatostatin receptors (SSTRs).
