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Biopharmaceuticals Oncology FDA

 News Release - February 6, 2017

First U.S. Multi-center Investigational Clinical Trial of 177 Lu PSMA-617 Targeted Radioligand Therapy in Metastatic Castration Resistant Prostate Cancer Receives FDA Clearance

Houston, TX; Los Angeles, CA, Feb. 06, 2017 -- (Healthcare Sales & Marketing Network) -- RadioMedix, Excel Diagnostics and Nuclear Oncology Center (EDNOC), and the Ahmanson Translational Imaging Division at the David Geffen School of Medicine at UCLA announced that the U.S. Food and Drug Administration (FDA) has given clearance to their Investigational New Drug (IND) application for their Phase II clinical trial for the use of 177Lu-PSMA-617 for targeted Radioligand Therapy (RLT) in patients with castration-resistant prostate cancer.

This will be the first prospective clinical trial in the US with prostate specific membrane antigen (PSMA) directed radioligand therapy providing new treatment options for patients with advanced, castration resistant prostate cancer.

"We are very excited to have received IND clearance from the FDA so that we can move forward with this clinical trial which makes PSMA-directed radioligand therapy available for the first time in the United States," said Dr. Ebrahim Delpassand, RadioMedix founder and CEO and Co-Principle Investigator at EDNOC. He continued: ”This work would not have been possible without the close collaboration of our colleagues at UCLA and EDNOC in the United States and ABX and ITG in Germany. ABX’s proprietary ligand PSMA-617 and ITG Isotope Technologies Garching’s EndolucinBeta® (no-carrier added 177Lu) used in this Radioligand Therapy are unique features of this highly avid and environmentally friendly RLT compound”.

Dr. Johannes Czernin, Chief of the Ahmanson Translational Imaging Division at UCLA and Co-Principle Investigator of this trial adds "This is a great milestone in the field of Nuclear Medicine in the United States and addresses an unmet need in treatment of patients suffering from hormone refractory prostate cancer".

According to the American Cancer Society, prostate cancer is the most common cancer and second most frequent cause of cancer-related death in men in the United States. Metastatic castration-resistant prostate cancer, defined as disease progression despite medical or surgical castration, develops in 10%–20% of prostate cancer patients. The corresponding 5-y survival rate is much lower (31%) than for patients with locally advanced prostate cancer (nearly 100%). Most patients with metastatic castration-resistant disease have metastases at diagnosis or develop widespread disease during the first 2 years of follow-up. First-line chemotherapeutic agents such as docetaxel, and second-line chemotherapy with cabazitaxel, are often toxic and prolong life by only a few months, underlining the need for new therapeutic strategies. Retrospective studies suggest that PSMA-targeted radioligand therapy with 177Lu-PSMA 617 has a favorable safety profile and a high efficacy. This multi-center trial at Excel Diagnostics and at the UCLA Ahmanson Translational Imaging Division will generate important prospective data regarding safety and efficacy. The trial is expected to start first half of 2017.

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 commercializing generator-produced radiopharmaceuticals based on Gallium-68 chemistry for PET imaging and therapeutic (Alpha and Beta-emitter labeled) radiopharmaceuticals for targeted radionuclide therapy in cancer. RadioMedix has also established two service facilities for academic and industrial partners: cGMP manufacturing suite for human clinical trials and probe development and small animal molecular imaging facility for evaluation of agents in animal models. More information at http://www.radiomedix.com

About Excel Diagnostics and Nuclear Oncology Center

Excel Diagnostics & Nuclear Oncology Center is one of the U.S. leading diagnostic imaging and therapeutic facilities located in Houston, Texas. Excel utilizes the latest generation of imaging equipment and offers a full range of imaging modalities. In addition to its comprehensive imaging services, Excel has required infrastructure to perform pioneer investigational clinical trials in the field of diagnostic molecular imaging and targeted radionuclide therapy. More information at http://www.exceldiagnostics.com

About the Ahmanson Translational Imaging Division at UCLA

Ahmanson Translational Imaging Division at the University of California, Los Angeles (UCLA) is specialized on molecular PET imaging, radioligand therapy and new theranostic concepts combining their profound expertise in preclinical imaging, drug development and the clinical translation of innovative diagnostic and therapeutic radionuclides. More information at http://www.pet.ucla.edu/


Source: RadioMedix

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