RadioMedix initiates the first Ga-68 PSMA (ProstaMedix™) clinical trial for diagnosis and management of prostate cancer in U.S.

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RadioMedix Inc. announced today its collaboration with RITA Foundation of Houston, and Excel Diagnostics and Nuclear Oncology Center to initiate the first clinical trial of 68Ga-radiolabeled PSMA (ProstaMedix™) In Houston, Texas. The clinical trial of “68Ga-PSMA PET/CT used for Diagnosis and Management of Prostate Cancer” was approved by USA Food and Drug Administration Agency on February 4th, 2015 and will start recruiting patients by mid-April 2015.

The prostate cancer is a significant medical problem that affects one in six men between the ages of 60 and 80, leading to approximately 30,000 deaths per year. At least 2 million men in the United States developed or had a prostate cancer (PC) with 233,000 new cases diagnosed in U.S., during year 2014.

ProstaMedix™ is a kit for labeling 68Ga, a positron Emission Tomography (PET) radioisotope for targeting the prostate-specific membrane antigen (PSMA), which is overexpressed in most prostate cancers. The initial studies of this radiotracer have confirmed its high sensitivity in detection of prostate cancer relapses and metastases. This phase I/II clinical trial (IND1243880, NCT02282137) will evaluate efficacy and safety of ProstaMedix™ in patients with suspected prostate cancer recurrence having non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI).

“The mortality from the prostate cancer is second only to lung cancer,” said Dr. Delpassand, Chairman and CEO of RadioMedix. “ProstaMedix™ is a state-of-the-art diagnostic PET/CT radiopharmaceutical that will significantly advance diagnosis and treatment management of patients with prostate cancer. Currently available conventional studies such as CT scan of the abdomen and pelvis have sensitivity of about only 20% for detection of prostate cancer recurrence. The sensitivity and specificity of this test is anticipated to be in the 90% range. This degree of accuracy will have a huge impact on the management of patients with prostate cancer and will address an important unmet need in this field,” continued Dr. Delpassand.

Izabela Tworowska, PhD, CSO of RadioMedix Inc.

About RadioMedix Inc.
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) 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.

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Izabela Tworowska, PhD
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