First Patient Dosed in Pivotal Phase III Study of TLX591-CDx (Illuccix®) for Prostate Cancer Imaging in Chinese Patients streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.
First Patient Dosed in Pivotal Phase III Study of TLX591-CDx (Illuccix) for Prostate Cancer Imaging in Chinese Patients malaysiasun.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from malaysiasun.com Daily Mail and Mail on Sunday newspapers.
/PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that a first patient has been dosed in China in the pivotal Phase.
/PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that a first patient has been dosed in China in the pivotal Phase.
MELBOURNE, Australia, Oct. 17, 2022 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved an investigational new drug (IND) application to commence a pivotal Phase III registration study of TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11), for the imaging of prostate cancer using Positron Emission Tomography (PET) that will bridge to the marketing authorisation granted to Illuccix by the United States Food and Drug Administration (FDA). The IND application was submitted in partnership with Grand Pharmaceutical Group Limited (Grand Pharma), Telix's partner in the Greater China region. The bridging study is required to provide data obtained in a Chinese population to establish that the diagnostic efficacy of TLX591-CDx is equivalent in Chinese and Western populations. This study will enroll up to 110 patients with suspected recurrent