First Patient Imaged in Prostate Imaging Study
MELBOURNE, Australia, Aug. 13, 2018 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX.TLX) (“Telix”, the “Company”), an Australian biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or “molecularly-targeted radiation” (“MTR”) is pleased to announce that Memorial Sloan Kettering Cancer Center (“MSK”) 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 68Ga-PSMA-11 (“PSMA Imaging”). Telix is supporting the trial in the form of access to cold kits (DMF: 032631) for the preparation of the PSMA Imaging agent (“Kit”).
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.”
About Telix Pharmaceuticals Limited
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 www.telixpharma.com.
About the US Prostate Cancer Imaging Market
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.1 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.2
This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States, or in any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933 (the “US Securities Act”), or under the securities laws of any state or other jurisdiction of the United States and may not be offered or sold within the United States, unless the securities have been registered under the US Securities Act or an exemption from the registration requirements of the US Securities Act is available.
None of the products referred to in this release have obtained a marketing authorization from the US Food and Drug Administration (FDA).
1 American Cancer Society : https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html
2 Jadvar et al. J Nucl Med February 1, 2018 vol. 59 no. 2 228-229
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