The Telix Pharmaceuticals Ltd (ASX: TLX) share price is racing higher again on Wednesday after the release of two positive announcements.
At the time of writing, the nuclear medicine-focused biopharmaceutical company's shares are up 9% to $4.07.
This means the Telix share price is now up 166% year to date.
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What did Telix announce?
The first announcement reveals that the US Food and Drug Administration (FDA) has approved the institutional use of Ga-PSMA-11 at the University of California, Los Angeles (UCLA) and the University of California, San Francisco (UCSF) under an academic New Drug Application (NDA) submission.
Management notes that this is a highly anticipated event within the US nuclear medicine industry. It paves the way for the FDA to approve commercially available products, enabling the broader availability of this technology to American men with prostate cancer.
Telix's CEO, Dr. Christian Behrenbruch, commented: "We offer our congratulations to Drs. Hope, Czernin, and Calais at UCSF and UCLA for their success in achieving this limited institutional approval for 68Ga-PSMA. Their efforts pave the way for broader commercial dissemination of this important technology, and they have been fundamental to physician and regulator education of the importance of advanced prostate imaging techniques using nuclear medicine."
What else was announced?
Telix also announced that it has been granted Human Research Ethics Committee (HREC) approval and received Clinical Trial Notification (CTN) clearance by the Therapeutic Goods Administration (TGA) to commence its first-in-human Phase I study of its next generation prostate cancer therapy product TLX592, in patients with advanced prostate cancer.
Like Telix's existing TLX591 antibody development program, TLX592 targets prostate specific membrane antigen (PSMA), which management notes is a target that is almost ubiquitously expressed by prostate cancer cells.
TLX592 has been engineered to clear far more rapidly from a patient's circulation, making it suitable for use as a targeting agent for actinium-225. Actinium is a potent therapeutic alpha emitting radionuclide and treatment.
According to the release, the Phase I "CUPID" study is a single centre, open-label trial that will evaluate the safety and tolerability, pharmacokinetics, biodistribution, and radiation dosimetry of TLX592 in patients with advanced prostate cancer.
Dr. Behrenbruch commented: "We are delighted to have been granted approval to commence the Phase I CUPID study for TLX592. Telix's proprietary RADmAb technology fundamentally underpins our ability to develop new TAT treatments for patients with metastatic cancer."
"In the case of TLX592, the clinical objective is to treat patients with prostate cancer that have a low disease burden for which alpha therapy is ideally suited, as well as potentially treating patients that no longer respond to conventional lutetium PSMA therapy. Telix has one of the broadest TAT pipelines in the industry and we are pleased to see our R&D efforts heading into the clinic," he concluded.
