DetectNET™: This is a Cu-64 labeled DOTATATE, a diagnostic agent for management of somatostatin expressing neuroendocrine cancers using PET/CT technology. This agent showed extremely high sensitivity and specificity in phase III clinical trial. RadioMedix has received orphan Drug Designation (ODD) on this drug from U.S. FDA . New Drug Application (NDA) has been submitted to FDA on January 3rd, 2020. The drug is currently under review at FDA with PDUFA date of September 3, 2020. Curium Pharma will be the manufacturer and distributor of the drug in the United States.
DetectNET™ Neuroendocrine Tumors
RMX-PSMA Theranostics Prostate Cancer
RMX- PSMA is RadioMedix’s proprietary ligand that targets Prostate Specific Membrane Antigen (PSMA) with high affinity in metastatic Castration Resistant Prostate Cancer CRPC). RadioMedix has received FDA permission to start clinical trial on Cu-64 labeled RMX-PSMA as Positron Emission Tomography (PET) diagnostic agent for detection of PSMA expressing prostate cancer. The therapeutic version of this molecule is currently in the pre-clinical phase with first in human trial planned for first quarter of 2021.
AminoMedix™ Kidney protection during PRRT
This is kidney protective agent to mitigate kidney toxicity as a result of Peptide Receptor Radionuclide Therapy (PRRT).
This product will be commercially available in the third quarter of 2020.
AlphaMedix™ Neuroendocrine Tumors
AlphaMedix™ : First Pb212 labeled Somatostatin analogue Targeted Alpha-emitter Therapy (TAT) agent for treatment of metastatic or inoperable Somatostatin expressing Neuroendocrine Tumors (NET) with highly encouraging safety and efficacy results. Below images show an example of impressive response to therapy in a patient with stage IV Pulmonary NET after 4 cycles of AlphaMedix therapy. The clinical trial has completed dose escalation phase and entering expansion cohort phase, in preparation for the registration trial. This drug has received Orphan Drug Designation by U.S. FDA. Pb-212 is an alpha emitter with high linear energy transfer accommodating maximum malignant cell kill. This project is performed in collaboration with Oranomed corporation.
Expanded Access Policy
RadioMedix, Inc. and Orano Med, two clinical stage radiopharmaceutical companies, are committed to developing innovative radioligand therapies, such as AlphaMedixTM for the treatment of adult patients with unresectable or metastatic, progressive somatostatin receptor expressing gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who are naïve to peptide receptor radionuclide therapy (PRRT).
AlphaMedixTM is a Targeted Alpha Therapy currently in Phase 2 clinical development, which consists of an SSTR-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha particles. Due to their high energy and short path length, alpha emitters enable specific targeting and killing of individual cancer cells, while minimizing toxicity to surrounding healthy tissue. AlphaMedixTM is the first Targeted Alpha Therapy to receive Breakthrough Therapy Designation.
Currently, RadioMedix, Inc. and Orano Med, do not offer an expanded access program and are not accepting expanded access requests for AlphaMedixTM. Our development resources are focused on conducting clinical trials that evaluate the safety and efficacy of our treatment.
If you have additional questions about RadioMedix and Orano Med’s expanded access policy, please email us at email@example.com and firstname.lastname@example.org .
Glioblastoma Multiforme (GBM)
This agent targets Glioblastoma Multiforme (GBM), one of the most aggressive brain tumors in humans. RadioMedix in collaboration with Vect-Horus in France is developing targeted diagnostic and alpha-therapeutic radiopharmaceuticals against GBM. One of the advantages of our drug is the capability to cross the blood brain barrier (BBB) in order to reach tumor cells, anywhere in the brain. Treatment at cellular level of the GBM is what is needed for this infiltrative malignancy in the brain.
GPC3 Expressing Solid Tumors
The GPC3 antigen is seen in several solid malignancies in humans. These cancers include urological malignancies, yolk sac tumors , ovarian cancers, and hepatocellular cancer in the liver. RMX-GPC3 is being developed as a theragnostic agent to address the unmet needs in diagnosis and treatment of these cancers.
* THESE DRUGS HAVE NOT BEEN APPROVED BY THE FDA