Vect-Horus and RadioMedix Announce FDA Approval of Exploratory IND of Diagnostic 68 Ga-RMX-VH in Glioblastoma Multiforme
MARSEILLE, France & HOUSTON--(BUSINESS WIRE)--#PETimaging--Vect-Horus and RadioMedix are pleased to announce the FDA clearance of exploratory Investigational New Drug (eIND) application to evaluate 68Ga-RMX-VH for the detection and mapping of Low Density Lipoprotein Receptor (LDLR) overexpressed in Glioblastoma Multiforme (GBM). The Phase 1 exploratory study sponsored by RadioMedix will start enrollment upon IRB « Internal Review Board » approval. The study will investigate safety, dosimetry and distribution of 68Ga-RMX-VH in patients with primary or recurrent GBM. The eIND clinical study will proceed in Excel Diagnostic and Nuclear Oncology Center (Houston, TX).
Glioblastoma multiforme is one of the most aggressive brain tumors in humans and is a serious and life-threatening condition. RMX-VH conjugate targets the LDLR, which is overexpressed in many cancer cells, including glioblastoma.
Vect-Horus and RadioMedix signed in October 2019 a partnership agreement to co- develop radiotheranostic agent for the diagnosis (Dx) and radiotherapy (Rx) of GBM using Vect-Horus expertise in targeting tumors and RadioMedix know-how in developing radiopharmaceuticals. Under the terms of the collaboration, both parties will share the costs of development until Phase 1 (Dx & Rx). The radiotheranostic agent will be then out licensed to RadioMedix for further clinical development and commercialization.
“We look forward to embarking on our next chapter as a clinical-stage company, harnessing the power of our platform VECTrans® to discover and develop new vectors that can target different tissues” said Alexandre Tokay, CEO of Vect-Horus.
“The FDA clearance marks a significant step in the continuing development of 68Ga-RMX-VH as well as our collaboration with RadioMedix. We are excited to follow the progress of this agent and the upcoming clinical trial” said Dr Jamal Temsamani, Director of Drug Development of Vect-Horus.
“GBM is one of the most aggressive human cancers and new diagnostic probes and targeted therapies are desperately needed to address this unmet need. The pre-clinical studies on RMX-VH ligand is highly promising and we are hoping to see similar targeting effectiveness in human GBM” said Dr Ebrahim Delpassand, CEO of RadioMedix.
“We are excited to initiate first in human exploratory clinical study of 68Ga-RMX-VH and evaluate the LDLR-targeting properties of this agent in GBM” said Izabela Tworowska, PhD, CSO of RadioMedix. “Our long-term-goal is to develop radiotheranostic drug for glioblastoma multiforme and expend the treatment option available for GBM patients.”
Vect-Horus designs and develops vectors that facilitate targeting and delivery of therapeutic or imaging agents to organs, including the brain and tumors. Vect-Horus combines these different agents to its vectors that specifically target various receptors, allowing these agents to cross natural barriers (including the blood-brain-barrier) which limit access of therapeutic or imaging agents 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 (INP, UMR7051, CNRS and Aix Marseille University), headed by Dr Michel Khrestchatisky, co-founder. To learn more about Vect-Horus, visit www.vect-horus.com.
RadioMedix, Inc. is a clinical stage biotechnology company, based in Houston, Texas, focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. The company is developing radiopharmaceuticals for PET imaging and therapy (alpha and beta-labeled agents). RadioMedix established contract service facilities for academic and industrial partners including Drug Discovery Center for the probe development, a Pre-clinical Core Facility for pre-clinical evaluation of radiopharmaceuticals, and full cGMP and analytical suites for late-stage human trials, and post approval commercial manufacturing facility, Spica Center.
To learn more, visit www.radiomedix.com.
Elodie Dormes, Business Development Sr Manager
Izabela Tworowska, PhD, CSO