FDA Authorization of IND for 225Ac-PSMA I&T Targeted Alpha Therapy for Castration Resistant Prostate Cancer

Posted by RadioMedix . on

Houston-Texas August 2nd, 2021

Excel Diagnostics and Nuclear Oncology Center (EDNOC), a premier Diagnostic Imaging and Radioligand Therapy   center in Houston, Texas announces approval of its physicians sponsored Investigational New Drug (IND) application for providing Targeted Alpha Therapy (TAT) with 225Ac-PSMA I&T for metastatic Castration Resistant Prostate Cancer (mCRPC).  “We are glad to be able to make this game changing drug available to our patients suffering from mCRPC.  Excel Diagnostics and Nuclear Oncology Center has been a pioneer in bringing new targeted Radioligand Therapies such as Lu-177 DOTATATE, and Lu-177 PSMA to serve our patients in the United States. The addition of 225Ac-PSMA I&T is in continuation of our mission to address unmet needs in the field of Nuclear Oncology” said Dr. Ebrahim Delpassand, Chairman and Medical Director of EDNOC and co-Principle Investigator of the trial. “PSMA is an established prostate cancer target. Highly encouraging results have been reported by using Targeted Alpha Therapy (TAT) Radiopharmaceuticals in conditions such as neuroendocrine, prostate, or hematological malignancies. These breakthroughs have brought significant amount of hope to our patients suffering from different types of advanced cancers.” Said Dr. Rodolfo Nuñez, Director of Nuclear medicine Department at EDNOC and Co-Principle Investigator of the trial.

“We are pleased to be able to facilitate the availability of 225Ac-PSMA I&T by manufacturing this drug at RadioMedix. We firmly believe that the menu of targeted Radioligand Therapies will only increase in the future. RadioMedix with its wide range of capabilities, from drug discovery to scale up commercial manufacturing, is ready to meet this challenge” Said Dr. David Ranganathan, Director of CMC and Regulatory affairs at RadioMedix.

About Excel Diagnostics and Nuclear Oncology Center (EDNOC)

EDNOC  is a premier outpatient facility  offering full spectrum of diagnostic imaging, nuclear medicine and Radioligand therapies. In addition to our comprehensive and state of the art imaging services, we have assembled a staff of highly skilled technical and medical professionals to meet and exceed the demanding standards of the industry. EDNOC is fully capable of conducting sponsored clinical research trials in the field of diagnostic and therapeutic nuclear medicine. All our research staff are GCP Trained and CITI certified consisting of highly trained, board certified investigators, study coordinators, patient recruiters and support staff. At Excel, you will find areas designed to safely handle and administer radiopharmaceuticals, patient care areas, and physician interpretation resources. The Excel Clinical Research Department (ECRD) is a dedicated department to assist investigators in their clinical trials. Our team is fully trained regarding rules and regulations of conducting human research, FDA requirements, and IRB compliance. We offer our expertise in conducting clinical research to a variety of academic institutions and pharmaceutical companies. ECRD works closely with CROs & IRBs, to support sponsored clinical trials in the field of oncology radiopharmaceuticals. In April of 2020, Excel passed FDA inspection of one of its investigational drugs with no deficiencies or citations. For more information please visit us at: www.exceldiagnostics.com

About RadioMedix

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).  RadioMedix has also established contract service facilities for academic and industrial partners including discovery probe development, a small animal molecular imaging facility for pre-clinical evaluation of radiopharmaceuticals, and full cGMP and analytical suites for late-stage human clinical trials, and post approval commercial manufacturing. To learn more, visit www.radiomedix.com and LinkedIn. For more information about this press release, please contact: media@radiomedix.com



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