Rhine Pharma Announces First Patient Dosed with PSMA-Targeted Rhenium-188 in RHINO Trial

Rhine Pharma Announces First Patient Dosed with PSMA-Targeted Rhenium-188 in RHINO Trial

Melbourne (Australia) | 9 October 2025

Rhine Pharma today announces that the first dose of RHN001-Tx has been administered in the Phase 1/2a ‘RHINO’[1] investigator-initiated trial (IIT) in men with PSMA[2]-positive prostate cancer. RHINO is sponsored by the Nuclear Medicine Research Infrastructure (NuMeRI) at the University of Pretoria in South Africa under the supervision of Professor Mike Sathekge. Rhine Pharma is providing funding support for RHINO together with the investigational products, RHN001-Dx and RHN001-Tx.

This achievement marks the first time a patient has been dosed with PSMA targeted rhenium-188 (¹⁸⁸Re) in a clinical trial, a significant milestone for Rhine Pharma and the nuclear medicine industry. This follows completion of a 10-patient imaging cohort for safety and dosimetry analysis with the companion diagnostic RHN001-Dx.

RHINO is exploring clinical utility of a therapeutic and diagnostic (‘theranostic’) pair derived from RHN001 (PSMA-GCK01), a PSMA-targeting small molecule. RHN001 was developed through a collaboration between Telix and Heidelberg University Hospital (UKHD)[3], which resulted in pre-clinical validation and first-in-human evaluation of rhenium-188 (¹⁸⁸Re) based radiopharmaceutical therapy[4] and technetium-99m(^99mTc) based SPECT[5] imaging.

This “theranostic” pair, designated RHN001-Tx (for therapy) and RHN001-Dx (for imaging), have the potential to enable access to radiopharmaceuticals for patients in certain geographies where ¹⁷⁷Lu availability may be limited. They can be produced using compact, easily-transportable generators (for ¹⁸⁸Re and ^99mTc), potentially under practice of pharmacy as with other generator-based radiopharmaceuticals, with imaging performed using widely available SPECT scanners.

Professor Sathekge, Principal Investigator of the RHINO trial and CEO and President of NuMeRI said, “The use of generator-based isotopes for prostate cancer imaging and therapy is a very promising solution for expanding access to more patients. Many regions in the world, including Africa, lack the infrastructure needed to produce and ship conventional radiopharmaceuticals. We are pleased to be partnering with Telix and Rhine Pharma, and my team is optimistic that the RHINO trial will provide a future potential clinical proof-of-concept for SPECT imaging with RHN001-Dx and therapy with RHN001-Tx.”

About the RHINO trial

The RHINO trial is a Phase 1/2a theranostic trial exploring the safety profile and dosimetry of both RHN001-Tx and RHN001-Dx in patients with advanced prostate cancer. Its primary objective is to identify the recommended Phase 2 dose (RP2D), and schedule of administration for RHN001-Tx in men with progressive PSMA-positive prostate cancer who have had adjuvant androgen deprivation therapy and/or taxane-based chemotherapy. Secondary objectives are to assess the overall safety profile and the dosimetry of RHN001-Tx and RHN001-Dx in men with prostate cancer, and to assess defined health-related quality of life measures. 

The first cohort of patients received RHN001-Dx for safety and dosimetric analysis. The second cohort (in progress) will receive RHN001-Tx for safety and dosimetric analysis, while the third cohort will receive escalating doses of RHN001-Tx to identify the RP2D and schedule of administration for RHN001-Tx.

About RHN001

The RHN001 technology platform consists of a targeting agent that can be conjugated with a true-theranostic pair of radioisotopes: ¹⁸⁸Re for therapeutic use and ^99mTc for imaging. ¹⁸⁸Re is a highly differentiated therapeutic beta-emitting isotope that is regarded as an attractive option for radiopharmaceutical therapy applications due to its high energy output over a 16.9 hour half-life and its ability to be reliably produced at the point of care via a generator⁴.

Radiopharmaceuticals based on more common therapeutic radioisotopes (on market or in development) such as lutetium-177 (¹⁷⁷Lu) and actinium-225 (²²⁵Ac), are typically centrally manufactured in facilities that require significant investment and infrastructure to operate, such as reactors or cyclotrons. The ¹⁸⁸Re-based approach decentralizes drug manufacturing and may be suitable for a wide variety of markets and clinical applications where radiopharmaceutical manufacturing infrastructure or supply chain is limited.

RHN001-Tx and RHN001-Dx have not received a marketing authorization in any jurisdiction and are for investigational use only.

About Rhine Pharma

Rhine Pharma™ is a wholly-owned subsidiary of Telix Pharmaceuticals Ltd. Its mission is to expand global access to innovative cancer imaging and therapy by leveraging the unique benefits of technetium-99m(^99mTc) and rhenium-188 (¹⁸⁸Re). Visit http://www.rhine-pharma.com for further information.

[1] South African Clinical Trials Registry ID: DOH-27-112024-4693.

[2] Prostate-specific membrane antigen.

[3] Telix ASX disclosure 10 February 2021.

[4] Telix media release 15 February 2023. Cardinale et al. Journal of Nuclear Medicine. 2023.

[5] Single photon emission computed tomography.