Houston, TX, USA and Marseille, France, Nov. 15, 2022 (GLOBE NEWSWIRE) — RadioMedix and Vect-Horus are pleased to announce that they have successfully dosed the first patients in an exploratory Investigational New Drug (eIND) application to evaluate 68Ga-RMX-VH for the diagnostic of Glioblastoma Multiforme (GBM) and Pancreatic ductal adenocarcinoma (PDAC). This radiotracer will serve as a companion diagnostic for future Targeted Alpha Therapy (TAT) for these cancers. 68Ga-RMX-VH is a positron-emitting tomography (PET) agent that targets the Low-Density Lipoprotein Receptor (LDLR) overexpressed in some solid tumors such as GBM and PDAC. The objective of this exploratory study is to evaluate the safety, dosimetry, and bio-distribution of 68Ga-RMX-VH in patients with solid tumors. GBM is the most common malignant primary brain tumor in adults and is a serious and life-threatening disease. PDAC is one of the most chemo-resistant and radio-resistant types of cancers due to the dense pancreatic connective tissue and the diversity of genetic mutations. RadioMedix and Vect-Horus have already signed a co-development and a licensing agreement. Both parties will share the costs of development until Phase 1 for diagnostic and radiotherapy. RadioMedix is leading the clinical development and future commercialization.
“Both GBM and PDAC are considered among the most aggressive human cancers. Our current therapeutic approaches for these cancers are invasive and fail meaningful results while adversely effects on the quality of life of our patients. Our approach starts with PET/CT imaging of the diagnostic version of the drug to confirm adequate targeting of the cancers and then applying a therapeutic version of the drug to mainly target the malignant cells while sparing normal organs. All these are accomplished with simple intravenous administration of the drugs.” said Dr Ebrahim Delpassand, Chairman and CEO of RadioMedix. “Another complexity of treating GBM is being able to deliver the drug to the tumor by crossing the blood-brain barrier. Our preliminary results suggest that RMX-VH ligand can accomplish this task”. Added Dr. Delpassand
“The favorable results of the first PET/CT imaging scans of GBM and PDAC patients are the culmination of the extensive pre-clinical studies done by RadioMedix and Vect-Horus teams. RadioMedix is serving as a Sponsor and manufacturer of the clinical doses of 68Ga-RMX-VH.”, said Dr. Izabela Tworowska, CSO of RadioMedix. “Our company has a track record in the translation of radiotheranostics drugs, and we are committed to improving diagnosis and therapy of GBM and PDAC”, added Dr. Tworowska.
“We are excited to have successfully treated the first patients with 68Ga-RMX-VH. The preclinical and preliminary clinical data to date indicates potential diagnostic of this agent and we look forward to generating further evidence as we progress” said Dr. Temsamani, Director of Drug Development of Vect-Horus.
“The initiation of this clinical trial is an important milestone for Vect-Horus as it marks the initiation of the clinical program of the imaging candidate, 68Ga-RMX-VH and our transition to a clinical-stage Company. We are looking forward to generating clinical data together with our partner RadioMedix with the aim of improving both diagnostic and therapy for cancer patients and addressing this significant unmet medical need,” said Alexandre Tokay, CEO of Vect-Horus.
RadioMedix, Inc. is a clinical-stage biotechnology company, based in Houston and Humble, Texas. The company is focused on innovative targeted radiopharmaceuticals for the diagnosis, monitoring, and therapy of cancer. RadioMedix is developing radiopharmaceuticals for PET imaging and therapy (alpha- and beta-labeled agents). The company’s first diagnostic product 64Cu-DOTATATE (Detectnet®) was approved by US FDA in September 2020. RadioMedix is also sponsoring a phase II clinical trial for the treatment of metastatic or inoperable neuroendocrine cancer using 212Pb-DOTAMTATE (AlphaMedix™) Targeted Alpha-Therapy (TAT) with promising results. In addressing other unmet needs in oncology, RadioMedix is developing theranostic agents to treat brain tumors, and pancreatic ductal adenocarcinoma (PDAC). In addition, RadioMedix has 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, at its Spica Center, in Humble, Texas. To learn more, visit www.radiomedix.com. For more information about this press release, please contact email@example.com.
Vect-Horus develops vectors that facilitate the targeting of therapeutic or imaging agents to organs. Vect-Horus combines these different agents to its vectors that specifically target various receptors, allowing these agents to cross cellular barriers, that limit their access to their targets. The proof of concept of the technology has already been established in animal models using different vectorized molecules. Created in 2005, Vect-Horus is a spin-off of the Institute for Neurophysiopathology (UMR7051, CNRS and Aix Marseille University), headed by Dr. Michel Khrestchatisky, co-founder. To learn more, visit www.vect-horus.com. For more information about this press release, please contact firstname.lastname@example.org.
CONTACT: Izabela Tworowska, PhD CSO, RadioMedix Inc email@example.com
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