Trial's Objective Response Rate Endpoint Already Achieved
RadioMedix and Orano Med, two clinical stage radiopharmaceutical companies, today announced that the last patient has been dosed in the Phase II trial of the targeted alpha emitter therapy, 212Pb-DOTAMTATE (AlphaMedix). This trial is being conducted to evaluate the safety and effectiveness of AlphaMedix in peptide receptor radionuclide therapy (PRRT) of naive patients with somatostatin receptor-expressing neuroendocrine tumors (NET), regardless of the location of the primary tumor. Top-line data from the trial is expected in mid-2024. Remarkably, based on data already collected, the objective response rate (ORR) endpoint has already been achieved and is more than twice as high as the current standard of care.
"The completion of the Phase II trial enrolment is a significant milestone in the clinical development of our innovative targeted alpha-emitter radiotherapy, AlphaMedix, and brings us one step closer to having this drug available to patients," said Ebrahim Delpassand, MD, Chairman and Chief Executive Officer of RadioMedix. "Previous studies have shown targeted alpha therapy (TAT) with AlphaMedix is well-tolerated. The preliminary efficacy data seen to date are very promising, particularly achieving the planned ORR endpoint. As the trial progresses, we believe the ORR could improve further. We look forward to reporting data on the study in 2024, which we believe will show that AlphaMedix will provide substantial benefit over currently FDA approved therapies for patients with metastatic or inoperable SSTR-expressing NETs."
This Phase II trial is a multi-center, single arm, non-randomized, open-label basket trial. Forty-one patients with histologically confirmed NETs and positive somatostatin analogue imaging who have not received prior PRRT have been enrolled across four sites in the United States. Treatment consists of four cycles of AlphaMedix at 8-week intervals. The primary endpoint of the trial is safety and effectiveness of AlphaMedix. Efficacy endpoints include objective response rate (ORR) using RECIST v1.1 criteria, progression-free survival (PFS), and overall survival (OS). Additional information about the trial can be found on clinicaltrials.gov: NCT 05153772.
Julien Dodet, President, and Chief Executive Officer of Orano Med, noted: "Completing this Phase II trial enrolment on schedule is a great achievement everyone involved and confirms the strong interest of the medical community for targeted alphatherapies with lead-212. We are convinced that targeted alphatherapies, such as AlphaMedixTM, are the future of radiopharmaceutical therapies, providing an increased cytotoxic potential against cancer cells with limited toxicity to surrounding healthy cells. This reinforces Orano Med's commitment to make innovative lead-212-based therapies available to the medical community and patients worldwide."
About Targeted Alpha Therapy
Targeted alpha therapy (TAT) relies on a simple concept: combining the ability of biological molecules to target cancer cells with the short-range cell-killing capabilities of alpha-emitting radioisotopes. Alpha decay consists of the emission of a helium nucleus (alpha particle) together with very high linear energy transfer and a range emission of only few cell layers, resulting in irreparable double strand DNA breaks in cells adjacent only to area of alpha emission. This approach results in an increased cytotoxic potential toward cancer cells while limiting toxicity to nearby healthy cells. As a result, alpha emitters are considered as the most powerful payloads to be found for targeted therapies.
About AlphaMedixTM
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). In the United States, around 12,000 patients are expected to be diagnosed with neuroendocrine tumors, with an average 5-year survival rate of 60% at a metastatic stage.
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.
More information about RadioMedix, visit: www.radiomedix.com.
About Orano Med
Orano Med is a clinical-stage biotechnology company which develops 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-Emitter Therapy (TAT). The company develops several treatments using 212Pb combined with various targeting agents. 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.
More information about Orano Med, visit: www.oranomed.com.
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Contacts:
Media Contacts
RadioMedix, Inc.
Izabela Tworowska, PhD.
Chief Scientific officer
+ 1 713-358-6562
itworowska@radiomedix.com
Orano Med
Jason D. Hurt, MD
Chief Medical Officer
Jason.hurt@oranomed.com
+1 614 886 1698
Halsin Partners (for Orano Med)
Mike Sinclair
msinclair@halsin.com
+44 7968 022075
