Excellent news for those who don’t have Gastroenteropancreatic NETs (GEP-NETs). A trial of PRRT is being set-up for the less common types of NET including those with an unknown primary. Using the DOTATOC radionuclide rather than the Lutathera model of using DOTATATE, this trial will cater for Pulmonary, Pheochromoctyoma, Paraganlioma, Unknown Primary and Thymic Neuroendocrine Tumours.
Excel Diagnostics and Nuclear Oncology Center (EDNOC) announced today that its physician sponsored Investigational New Drug (IND) application to evaluate safety and efficacy of Lu-177 DOTATOC in adult subjects with Somatostatin receptor (SSTR) expressing Pulmonary, Pheochromocytoma, Paraganglioma, Unknown primary, and Thymic Neuroendocrine Tumors (PUT-NET), has received approval to proceed by USA Food and Drug Administration (FDA) and also charge authorization has been granted (IND#143631, NCT04276597). This IND is anticipated to start enrolling patients by early March 2020.
“PUT Neuroendocrine tumors (PUT NET) express somatostatin receptor on the tumor cells and can be amenable to targeted Peptide Receptor Radionuclide Therapy (PRRT)”. Said Dr. Ebrahim Delpassand, Chairman and Medical Director of EDNOC. “PRRT with Lu-177 DOTATATE has already received approval from FDA and is commercially available in the United States to treat patients with Gastro-Entero-Pancreatic Neuroendocrine Tumors (GEPNETs). Currently, there is no commercially available PRRT drug to treat SSTR expressing PUT-NET. Our IND is addressing this unmet need for our patients”. Added Dr. Delpassand. “Our’s and other’s previous exploratory experiences of PRRT in PUT-NET patients suggests that these patients may benefit from PRRT. Our study is the first official trial under FDA jurisdiction to evaluate the safety and effectiveness of Lu-177 DOTATOC in PUT-NET patients. We hope the results of our study can pave the path in adding this indication to future PRRT agents”. Continued Dr. Delpassand. “We are pleased to be able to manufacture Lu-177 DOTATOC at RadioMedix. This adds to several other Radioligand therapy agents currently manufactured under cGMP guidelines by RadioMedix for different clinical trials.” Said Dr David Ranganathan, Director of CMC Regulatory Affair at RadioMedix.
About Excel Diagnostics and Nuclear Oncology Center
Excel Diagnostics & Nuclear Oncology Center (EDNOC) is Houston’s leading diagnostic imaging and therapeutic facility. EDNOC utilizes comprehensive imaging services, and therapeutic nuclear medicine. EDNOC has assembled a staff of highly skilled technical and medical professionals to meet and exceed the demanding standards of the industry. EDNOC has been pioneered in bringing several targeted radionuclide Therapy agents such as Lu-177 DOTATATE, LU-177 PSMA-617 , and diagnostic PET/CT agents such as Ga-68 DOTATATE , and Ga-68 PSMA-11 to the patients coming from across the country, under FDA authorized Investigational New Drug applications. Our strong infrastructure and experience for conducting research has allowed us to be a preferred clinical trial site in the area of diagnostic and therapeutic nuclear medicine.
RadioMedix, Inc. is a clinical-stage biotechnology company, based in Texas, focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. The company is commercializing radiopharmaceuticals for PET imaging and targeted alpha and beta-emitter therapy. RadioMedix established research and contract service facilities for academic and industrial partners at two locations: the cGMP Dose Manufacturing and Analytical suites for clinical trials, and the Drug Discovery and Pre-clinical Core Facility in Houston, TX. Also, a new state of art commercial manufacturing facility located in Humble, TX, has been established.
I will flesh this out in due course but this is great news for these new types of NET.
Thanks for reading