MARSEILLE, France & HOUSTON--(BUSINESS WIRE)--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.
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“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.”