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.
GlucoMedix Theranostics: Breast, ovarian and lung cancer
GlucoMedix/OncoMedix Theranostics: has completed the pre-clinical ligand selection and phase I clinical dosimetry study is expected in the second half of 2020. This agent targets glucose transporter in the cancer cells and can be used as a vector for targeted alpha or beta radionuclide therapies. RadioMedix has patent on this product. Since the ligand targets glucose transporters any cancer with high glucose metabolism can be a suitable target. Majority of human cancer cells utilize glucose as their main source of energy (Warburg effect).
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.
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