World News: 23:00 GMT Sunday 12th August 2018. [Telix Pharmaceuticals Limited via Globe Newswire via SPi World News]
MELBOURNE, Australia, Aug. 13, 2018 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX.TLX) (“”, the “”), an Australian biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or “molecularly-targeted radiation” (“”) is pleased to announce that Memorial Sloan Kettering Cancer Center () has imaged the first two patients in a 500 patient Phase II Expanded-Access Investigational New Drug (IND) study for imaging prostate cancer with the investigational agent Ga-PSMA-11 (). Telix is supporting the trial in the form of access to cold kits (DMF: 032631) for the preparation of the PSMA Imaging agent (“”).
Telix and ANMI SA have partnered to develop the Kit for the US market, including submission of a Drug Master File (DMF) to the US Food and Drug Administration (FDA), with Telix as the US commercialization partner. Over the past three months, MSK and Telix have collaborated to validate the use of the Kits at MSK’s radiopharmacy service. MSK also amended their IND (NCT03204123) to enable the use of the Kit in this study.
Telix Pharmaceuticals (US) President, Bernard Lambert, Ph.D stated, “We are grateful for the collaboration with MSK and the valuable product development insights we have gained from working with one of America’s most vibrant oncology-focused radiopharmacy services. We are also very pleased to support MSK’s Expanded Access IND, which provides an important service to men with prostate cancer.”
Jason S. Lewis, Ph.D, Chief, Radiochemistry and Imaging Sciences Service at MSK, noted, “PSMA prostate imaging may provide benefit to men diagnosed with prostate cancer but in order for this technique to become more widely used in cancer care, access needs to improve. Kit-based approches could prove to be an ideal way to lower cost and make prostate imaging more accessible.”
Telix Pharmaceuticals Limited (Telix) is a global biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or “molecularly-targeted radiation” (MTR). The company is headquartered in Melbourne with international operations in Brussels (EU), Kyoto (JP) and Indianapolis (US). Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical need in renal, prostate and brain (glioblastoma) cancer. Telix is listed on the Australian Securities Exchange (ASX:TLX). For more information visit .
Other than skin cancer, prostate cancer is the most common male cancer in the United States, with approximately 160,000 new cases annually and three million men living with prostate cancer. There remains a major unmet need to better diagnose and stage men with prostate cancer, from initial diagnosis all the way to therapeutic monitoring in patients with late-stage metastatic disease. The prostate imaging market in the US is estimated to be a USD $500 million market opportunity, likely to be dominated by the use of Positron Emission Tomography (PET) and imaging agents targeting prostate-specific membrane antigen (PSMA) in particular.
Telix Corporate Contact
Dr Christian Behrenbruch
Telix Pharmaceuticals Limited
Telix Investor Relations (Australia)
Tel: +61 (3) 9866 4722
Telix Investor Relations (US)
Tel: +1 212 452 2793
Globe Newswire: 23:00 GMT Sunday 12th August 2018
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