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“I am very pleased that we have received approval from Swissmedic and the ethics committee thanks to the good cooperation of all those involved and that the study can now enter the clinical phase,” says Prof. Dr. Berend Snijder, systems biologist at ETH Zurich, who leads the “RAPID 01” study. He developed and performs it together with Prof. Dr. med. Markus Manz and Prof. Dr. med. Alexandre Theocharides from the University Hospital Zurich and the University of Zurich. “We will examine the samples of a total of 88 AML-patients with our ‘pharmacoscopy’ technology, which was further developed at ETH Zurich, and thus contribute to the personalized treatment of these patients,” explains Snijder.

With pharmacoscopy, a small tissue or blood sample from the patient is combined with a range of different pharmaceuticals in the laboratory. In a second step, the cells are stained using immunofluorescence. Then, millions of images are taken using automated high-throughput microscopy and are analyzed with the help of artificial intelligence. By examining the reactions of the individual samples, personalized therapy suggestions can be generated. In the study, patients are randomized to receive either a therapy recommended by pharmacoscopy or the routine standard of care therapy. Patients in the experimental group are thus treated with a therapy tailored to their needs. Ideally, this could lead to a better AML response to therapy.

“PROGNOSTICS” study already in full swing

The second PHRT-financed clinical study “PROGNOSTICS” has been applying a radiopharmaceutical containing “terbium-161” developed at PSI to patients since March 2024. The project leader, Prof Dr Roger Schibli, Head of the Centre for Radiopharmaceutical Sciences (CRS) at PSI, is working together with Prof Dr Damian Wild, Dr Alin-Florin Chirindel and Dr. Guillaume Nicolas from the University Hospital Basel and Prof Dr Nicola Aceto from ETH Zurich. “If our hypothesis with this drug proves to be true, then patients with prostate cancer could be treated more effectively in future,” says Roger Schibli. “It was a joint effort of everyone involved in the project and it is thanks to a lot of voluntary overtime that we have come this far together,” says Prof. Dr. Cristina Müller, group leader at the CRS, who has been involved in the development of this radiopharmaceutical for over 10 years and conducted the preclinical studies, which PHRT also supported. For the clinical study, a total of 36 patients will be administered with the newly developed radiopharmaceutical.

The study involves the application of the newly developed terbium-161 containing radiopharmaceutical in a Phase I study at different dosages for patients suffering from metastatic, castration-resistant prostate cancer (mCRPC). The radiopharmaceutical was developed in such a way that both the radionuclide and the targeting agent were optimized, which could represent an improved alternative to radiopharmaceuticals currently using lutetium-177. Thanks to physical properties of terbium-161, individual micro metastases may be better destroyed, and a return of the cancer may be prevented or significantly delayed. Preclinical studies have repeatedly demonstrated the effectiveness of this novel radionuclide. In the currently on-going first part of the clinical study, the dosimetry is being investigated so that, in the second part of the study, the dosage shall be increased with the goal of reaching therapeutic efficacy.

Prof Dr Bernd Wollscheid, Chairman of the PHRT Executive Committee, adds: “It’s great to see that the initial vision of ETH/PHRT to bring benefits to patients through data insights gained in translational research programs can now be realized and tested in interventional clinical trials to change the current standard of care together with our clinical partners at University Spital Zurich and University Hospital Basel.”