GRAND PHARMA (00512) Achieves Primary Endpoint in China Phase III Clinical Study for Innovative Prostate Cancer Diagnostic RDC TLX591-CDx

Stock News12-21 18:14

GRAND PHARMA (00512) announced that its innovative investigational radiopharmaceutical diagnostic agent (RDC) TLX591-CDx (Illuccix®, gallium Ga 68 PSMA-11) for prostate cancer has achieved positive topline results in a Phase III clinical trial in China, successfully meeting the primary clinical endpoint. Additionally, the company’s RDC product TLX591 for prostate cancer treatment has been approved for inclusion in an international multicenter Phase III clinical study in China. The combination of these two products is poised to deliver more precise and efficient diagnostic and therapeutic solutions for prostate cancer patients in China.

The study was a single-arm, open-label Phase III clinical trial involving over 100 patients with biochemical recurrence of prostate cancer. Participants underwent positron emission tomography/computed tomography (PET/CT) or positron emission tomography/magnetic resonance imaging (PET/MRI) scans using TLX591-CDx to evaluate diagnostic efficacy, as well as safety and tolerability in the Chinese population.

Topline clinical results showed that TLX591-CDx achieved an overall positive predictive value (PPV) of 94.8% (confidence interval, CI: 85.9%-98.2%) for tumor detection. Specifically, PPV was 100.0% for tumors recurring in the prostate bed and soft tissue, lymph nodes, or organs (non-bone metastases) outside the pelvis; 94.7% for tumors recurring in pelvic regions (including lymph nodes) outside the prostate bed; and 87.0% for bone metastases.

The trial also stratified patients based on baseline prostate-specific antigen (PSA) levels. TLX591-CDx demonstrated high PPV across all subgroups, exceeding 90% even in patients with extremely low PSA levels (see table below). This suggests that TLX591-CDx PET imaging holds significant clinical value for early diagnosis in suspected biochemical recurrence of prostate cancer.

Furthermore, over two-thirds (67.2%) of patients had their treatment plans adjusted from baseline following TLX591-CDx PET imaging, indicating its substantial impact on clinical decision-making and optimization of treatment strategies for suspected biochemical recurrence cases.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap
Leave a comment