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MELBOURNE, Australia, Nov. 22, 2022 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces that a first patient has been dosed in a Phase II investigator-initiated study of TLX101 in combination with external beam radiation therapy (EBRT) in patients with recurrent high-grade gliomas (HGG), including glioblastoma multiforme (GBM). TLX101 (4-L-[131I] iodo-phenylalanine, or 131I-IPA) is one of Telix's lead therapeutic clinical programs and has been granted orphan drug designation in the U.S. and Europe. TLX101 targets L-type amino acid transporter 1 (LAT-1), typically over-expressed in many malignant tumours, including HGG/GBM. The IPAX-Linz study, which is being led by Professor Josef Pichlerat Kepler University Hospital in Linz, Austria, builds on data generated in the IPAX-1 study. The final results of the IPAX-1 study, reported in September 2022, demonstrated a favourable safety profile and encouraging preliminary therapeutic effect.[1] IPAX-Lin
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
MELBOURNE, Australia, Aug. 2, 2022 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today reports on regulatory progress for the Company's core prostate and kidney cancer imaging programs in the Asia Pacific (APAC) Operating Region, including progress in the major market of China with its strategic partner Grand Pharmaceutical Group Limited (Grand Pharma). TLX591-CDx (Illuccix) for prostate cancer imaging China: An Investigational New Drug (IND) application has been submitted by Telix's partner in Greater China, Grand Pharma, to the National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) - and accepted for review - for a pivotal Phase III registration study that will bridge to the United States Food and Drug Administration (FDA) approval of Illuccix. South Korea: As previously reported, an imported New Drug Application (NDA) has been submitted by Telix's partner in South Korea, DuChemBio Co, Ltd. (DuChemBio), to the Minist