Prospective, Multi-Center Study to Assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer

This study assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients with Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer

Start Date13 Jun 2024

Sponsor / Collaborator

ABX advanced biochemical compounds GmbH

CTIS2023-504026-19-01

/ RecruitingPhase 3

Prospective, Multi-Center Study to Assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients with Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer

Start Date05 Jun 2024

Sponsor / Collaborator

ABX advanced biochemical compounds GmbH

NCT05422105

/ RecruitingNot Applicable

Multicenter Evaluation of Diagnostic Performance of [18F]FPSMA-1007 PET/CT in Patients With Suspected Prostate Cancer

The diagnostic tools for detecting patients with early prostate cancer are limited due to poor diagnostic performance. The positron emission tomography (PET) combination with the diagnostic radiopharmacy is a non-invasive tool to provide the molecular imaging of the whole body and offer more comprehensive physiological information and then can raise the diagnostic performance. Prostate-specific membrane antigen (PSMA)-targeting pharmaceuticals have been regarded as the most promising diagnostic tool to diagnose patients with prostate cancer. Currently, the 18F-PSMA-1007 as PSMA-targeting 18F-radiolabeled pharmaceuticals have developed and successfully used in patients with intermittent- and high-risk prostate cancer or recurrent prostate cancer. The study aims to understand the diagnostic performance of 18F-PSMA-1007 PET/CT in different-stage prostate cancer patients by initiating the first multicenter clinical trial of 18F-PSMA-1007 in Taiwan.

Start Date01 Jul 2023

Sponsor / Collaborator

Primo Biotechnology Co., Ltd.

[+1]

100 Clinical Results associated with ABX advanced biochemical compounds GmbH

0 Patents (Medical) associated with ABX advanced biochemical compounds GmbH

Literatures (Medical) associated with ABX advanced biochemical compounds GmbH

01 Jan 2026·JOURNAL OF NUCLEAR MEDICINE

Efficacy of [ ¹⁸ F]PSMA-1007 PET/CT in Primary Staging of Prostate Carcinoma: A Systematic Review and Metaanalysis

Review

Author: Yun, Mijin ; Giesel, Frederik L ; Herrmann, Ken ; Hoepping, Alexander ; Maurer, Tobias ; Watabe, Tadashi ; Rahbar, Kambiz ; Rudolph, Ines

Staging of prostate carcinoma (PCa) still largely relies on histopathologic examination of prostate tissue. In the last few years, PET/CT with radiotracers that target the prostate-specific membrane antigen (PSMA) has emerged as a noninvasive and sensitive method for staging of PCa. Compared with [⁶⁸Ga]PSMA-11, [¹⁸F]PSMA-1007 is a relatively new radiotracer for PSMA PET/CT with favorable characteristics such as a longer physical half-life, reduced bladder background uptake, and improved availability due to production off-site. The objective of this systematic review and metaanalysis is to summarize the efficacy of [¹⁸F]PSMA-1007 in primary T, N, and M staging of PCa in comparison to histopathology. Methods: Clinical trials on primary staging of PCa with [¹⁸F]PSMA-1007 (both prospective and retrospective studies) were identified by a systematic search in PubMed. Relevant literature used histopathology as a comparator and reported discrete values for sensitivity and specificity. A metaanalysis assessed differences in diagnostic parameters. Results: Nineteen studies were included in this review: 10 studies reported on T staging (739 patients), 8 studies reported on N staging (865 patients), and 1 study reported on M staging (79 patients). For T staging, our metaanalyses of extraprostatic extension on a patient level based on 3 studies revealed a pooled sensitivity of 54% (95% CI, 46%-63%) and a pooled specificity of 92% (95% CI, 76%-98%). For N staging, our metaanalyses on detection of lymph node metastases on a patient level based on 5 studies revealed a pooled sensitivity of 42% (95% CI, 28%-57%) and a pooled specificity of 94% (95% CI, 90%-97%). In terms of sensitivity for M staging on a patient level, [¹⁸F]PSMA-1007 PET/CT outperformed all other tested conventional imaging modalities. Conclusion: PET/CT imaging with [¹⁸F]PSMA-1007 provides high sensitivity and specificity in T, N, and M staging of PCa when compared with histopathology. It offers the possibility to perform noninvasive primary T, N, and M staging before treatment in a single procedure.

01 May 2024·European Journal of Nuclear Medicine and Molecular Imaging

Combination of [18F]FDG and [18F]PSMA-1007 PET/CT predicts tumour aggressiveness at staging and biochemical failure postoperatively in patients with prostate cancer

Article

Author: Giesel, Frederik L ; Lee, Misu ; Lee, Seunghwan ; Hoepping, Alexander ; Kim, Sun Jung ; Kim, Dongwoo ; Kim, Jisu ; Oh, Kyeong Taek ; Choi, Young Deuk ; Yun, Mijin ; Kim, Hyun Jeong ; Kopka, Klaus

PURPOSE:

[¹⁸F]fluorodeoxyglucose ([¹⁸F]FDG) positron emission tomography/computed tomography (PET/CT) has limitations in prostate cancer (PCa) detection owing to low glycolysis in the primary tumour. Recently, prostate-specific membrane antigen (PSMA) PET/CT has been useful for biochemical failure detection and radioligand therapy (RLT) guidance. However, few studies have evaluated its use in primary prostate tumours using PSMA and [¹⁸F]FDG PET/CT. This study aimed to evaluate [¹⁸F]PSMA-1007 and [¹⁸F]FDG PET/CT for primary tumour detection and understand the association of metabolic heterogeneity with clinicopathological characteristics at staging and postoperatively.

METHOD:

This prospective study included 42 index tumours (27 acinar and 15 ductal-dominant) in 42 patients who underwent [¹⁸F]PSMA-1007 and [¹⁸F]FDG PET/CT and subsequent radical prostatectomy. All patients were followed for a median of 26 mo, and serum prostate-specific antigen levels were measured every 3 mo to evaluate biochemical failure. One-way analysis of variance, Tukey's multiple comparison test, and Fisher's exact test were performed.

RESULTS:

All 42 index tumours were detected on [¹⁸F]PSMA-1007 PET/CT, whereas only 15 were detected on [¹⁸F]FDG PET/CT (62.3% vs. 37.7%, p < 0.0001). A high SUV_max for [¹⁸F]PSMA-1007 was observed in tumours with high Gleason scores (GS 6-7 vs. GS 8-10; 12.1 vs. 20.1, p < 0.05). Tumours with [¹⁸F]FDG uptake were mostly ductal dominant (acinar-dominant 4/27; ductal-dominant; 11/15, p < 0.001), with lower [¹⁸F]PSMA-1007 uptake than tumours without [¹⁸F]FDG uptake (SUVmax 16.58 vs. 11.19, p < 0.001). There were 16.6% (7/42) of patients with pStage IV in whom the primary tumours were [¹⁸F]FDG positive. Biochemical failure was observed in 14.8% (4/27) of patients with [¹⁸F]FDG negative tumours but in 53.3% (8/15) of patients with [¹⁸F]FDG positive tumours (p = 0.013).

CONCLUSIONS:

[¹⁸F]PSMA-1007 PET/CT was superior to [¹⁸F]FDG PET/CT in detecting primary PCa. In contrast, tumours with [¹⁸F]FDG uptake are associated with larger size, a ductal-dominant type, and likely to undergo metastasis at staging and biochemical failure postoperatively.

01 Apr 2023·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

Phase III Study of¹⁸F-PSMA-1007 Versus¹⁸F-Fluorocholine PET/CT for Localization of Prostate Cancer Biochemical Recurrence: A Prospective, Randomized, Crossover Multicenter Study

Article

Author: Olivier, Pierre ; Gauthé, Mathieu ; Skanjeti, Andrea ; Hoepping, Alexander ; Weinmann, Pierre ; Giraudet, Anne-Laure ; Merlin, Charles ; Rudolph, Ines

The objective of this study was to compare ¹⁸F-PSMA-1007 PET/CT and ¹⁸F-fluorocholine PET/CT for the localization of prostate cancer (PCa) biochemical recurrence. Methods: This prospective, open-label, randomized, crossover multicenter study included PCa patients with prior definitive therapy and suspected PCa recurrence. All men underwent both ¹⁸F-PSMA-1007 PET/CT and ¹⁸F-fluorocholine PET/CT (102 received ¹⁸F-PSMA-1007 PET/CT first and 88 received ¹⁸F-fluorocholine PET/CT first). All images were assessed independently by 3 readers masked to all clinical information using a 3-point qualitative scale (0 = no recurrence, 1 = undetermined, and 2 = recurrence). Patients were monitored for approximately 6 mo. An independent panel with a urologist, radiologist, and nuclear physician reviewed all clinical data, including imaging and response to therapy, but were masked regarding PET/CT information; acting in consensus, they determined a patient-based and region-based composite standard of truth for PCa lesions. The "correct detection rates" for PCa lesions on a patient basis for each radiopharmaceutical were compared for the 3 readers individually and for the "average reader." Secondary objectives included determining whether PET/CT findings affected diagnostic thinking (impact of a test result on posttest vs. pretest probability of a correct diagnosis), therapeutic decision making (description and quantification of impact of diagnostic information gained with both radiopharmaceuticals on patient management), and adequacy of management changes. Results: A total of 190 patients were included. The primary endpoint was met. The overall correct detection rates were 0.82 for ¹⁸F-PSMA-1007 and 0.65 for ¹⁸F-fluorocholine (P < 0.0001) when undetermined findings were considered positive for malignancy and 0.77 and 0.57, respectively (P < 0.0001), when undetermined findings were considered negative for malignancy. A change in diagnostic thinking due to PET/CT was reported in 149 patients; ¹⁸F-PSMA-1007 contributed more than ¹⁸F-fluorocholine in 93 of these patients. In 122 patients, PET/CT led to an adequate diagnosis that benefited the patient; ¹⁸F-PSMA-1007 contributed more than ¹⁸F-fluorocholine in 88 of these patients. Conclusion: ¹⁸F-PSMA-1007 PET/CT is superior to ¹⁸F-fluorocholine PET/CT for the localization of PCa recurrence. Decision making was more beneficial when based on ¹⁸F-PSMA-1007 PET/CT results.

News (Medical) associated with ABX advanced biochemical compounds GmbH

24 Apr 2025

·www.prnewswire.com

Primo's Taoyuan Facility Achieves PIC/S GMP Certification, Paving the Way for Global Expansion in Nuclear Medicine.

TAIPEI, April 24, 2025 /PRNewswire/ -- Primo Biotechnology Co., Ltd. ("Primo") proudly announces that its Taoyuan pharmaceutical facility has successfully passed inspection by Taiwan Food and Drug Administration (TFDA) and has been award dual certification for PIC/S GMP and GDP. This achievement demonstrates Primo's dedication to meeting international quality standards for nuclear medicine production and sets the stage for global market growth. Continue Reading Primo Partners with ABX to Bring PB01 Closer to Taiwan’s Prostate Cancer Market. Since initiating construction in 2023, Primo has focused on establishing a high-efficiency, internationally compliant facility. By integrating advanced and automated production system with over 30 years of the team's radiopharmaceutical manufacturing experience in medical centers, the company achieved certification in less than two years. This milestone not only strengthens domestic supply capabilities but also accelerates clinical trial progress for new drug candidates and builds international client confidence—paving the way for expanded partnerships in the global markets. Furthermore, Primo obtained TFDA market approval in April 2025 for Fluorodeoxyglucose F-18 (18F-FDG). This essential radiopharmaceutical for PET/CT imaging plays a key role in diagnosing cancers as well as neurological and cardiac conditions. The commercial launch of F-18 FDG is expected positively contribute to the company's operational performance. Beyond F-18 FDG, Primo is actively developing a broad portfolio of radio theranostics radiopharmaceuticals. Recognizing the high technical and regulatory barriers within this field, Primo is also expanding into CRO (Clinical Research Organization) and CDMO (Contract Development and Manufacturing Organization) services. By integrating drug development, pre-clinical trials and manufacturing into its radiopharmaceutical platform. Primo enables close collaboration with partners and supports the acceleration of new drug approvals. In addition to GMP and GDP certification, Primo is licensed by Taiwan's Atomic Energy Council for the safe transport of radioactive materials. By following GDP standards, Primo ensures secure and efficient delivery of radiopharmaceuticals. Its strategic location, just 30 minutes from Taoyuan International Airport, provides a logistical edge for global operations. Securing PIC/S GMP and GDP certifications is a significant milestone for Primo. The company will continue to strengthen its manufacturing and research capabilities, enhancing its competitiveness in the global nuclear medicine market. By partnering with leading medical institutions worldwide, Primo is committed to delivering high-quality diagnostic and therapeutic radiopharmaceuticals to patients worldwide. About Primo Biotechnology Co., Ltd. Primo is a leading biotech company specializing in the development and manufacturing of radiopharmaceuticals. With internationally certified facilities, Primo is committed to using precision molecular imaging technology to bring hope and a future to cancer patients. Headquartered in Taipei, the company collaborates with domestic and international partners to drive advancements in precision cancer care. For more information, visit and follow on Facebook and LinkedIn. SOURCE Primo Biotechnology Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

19 Mar 2025

·pipelinereview.com

Primo Partners with ABX to Bring PB01 Closer to Taiwan’s Prostate Cancer Market

TAIPEI, Taiwan I March 19, 2025 I In response to the growing burden of prostate cancer in Taiwan, Primo Biotechnology Co., Ltd. (“Primo”) has formed a strategic partnership with Germany-based ABX advanced biochemical compounds GmbH (ABX) to lay the groundwork for introducing PB01 to the Taiwanese market. Data from Taiwan Cancer Registry indicate a steady increase in both, the incidence and mortality of prostate cancer, in recent years [1], underscoring the urgent demand for more accurate diagnostic tools. Radelumin, an innovative diagnostic radiotracer tailored specifically for prostate cancer patients, has already gained approval in France and multiple European countries [2]. Using advanced PET/CT imaging technology, Radelumin and its equivalent for the Taiwanese market, PB01, enable precise detection of Prostate Specific Membrane Antigen (PSMA) expression, helping physicians identify and monitor prostate cancer with exceptional accuracy. Since its European debut in 2021 [2], Radelumin has become a widely adopted tool for early detection, staging, and recurrence monitoring in high-risk prostate cancer cases. The partnership between ABX and Primo aims to bring this vital diagnostic tool to Taiwan, offering a new level of precision in cancer care. Primo CEO’s statement: “Precision treatment begins with precise diagnosis. The official introduction of PB01 in Taiwan is not only a beacon of hope for Taiwanese prostate cancer patients but also a groundbreaking milestone in ushering a new era of precision radiological diagnostics for cancer care in the region.” ABX CEO’s statement: “Primo is an excellent partner in Taiwan, known for its robust and compliant manufacturing capabilities. We are confident of PB01’s potential in the Taiwanese market and look forward to seeing this technology become a cornerstone of precision medicine for prostate cancer.” About ABX advanced biochemical compounds GmbH ABX is a worldwide leader in the production of starting materials for radiopharmaceuticals, headquartered in Germany. The company specializes in research, development and manufacture of precursors, reagent kits and cassettes used in radiochemical labeling reactions, providing high-quality products and services in multiple countries and regions. ABX is dedicated to innovation and quality, advancing the global nuclear medicine field. About Primo Biotechnology Co., Ltd. Primo is a leading biotech company specializing in the development and manufacturing of radiopharmaceuticals. With internationally certified facilities, Primo is committed to using precision molecular imaging technology to bring hope and a future to cancer patients. Headquartered in Taipei, the company collaborates with domestic and international partners to drive advancements in precision cancer care. For more information, visit https://primobt.com and follow on Facebook and LinkedIn. Source: [1] Taiwan ministry of health and welfare national health service, Taiwan cancer registry. [2] ABX’s press release in 2023. SOURCE: Primo Biotechnology

Diagnostic Reagents

12 Dec 2024

·www.accesswire.com

CIL Announces Breakthrough in Benzene Recovery, Addressing Cost, Environmental, and Supply Challenges for OLED Display Manufacturers

TEWKSBURY, MA / ACCESSWIRE / December 12, 2024 / Cambridge Isotope Laboratories, Inc. (CIL) has successfully developed and implemented a game-changing benzene-d6 recovery program, addressing major pain points for manufacturers of organic light-emitting diode (OLED) displays. This innovative service reduces costs, minimizes environmental impact, and conserves scarce deuterium supplies.OLED display producers rely heavily on deuterated benzene (benzene-d6) as a critical starting material in their synthesis processes. However, this results in significant quantities of depleted benzene-d6, which is no longer usable but still retains considerable deuterium value. The disposal of such depleted material poses environmental challenges and substantial expenses.CIL's benzene-recovery program offers a transformative solution. Customers can now return their depleted benzene-d6 to CIL, where it undergoes a proprietary re-enrichment process to restore it to virgin material quality. This service is available at a significant cost savings compared to new benzene-d6, providing significant economic benefits.Beyond the financial advantages, the program has far-reaching environmental and supply implications. It eliminates the need for costly disposal, reduces the demand on increasingly scarce deuterium (derived from heavy water, D2O) and conserves this vital resource for its growing applications in science, medical diagnostics, pharmaceuticals, and semiconductor production.Recycling offers several sustainable benefits. It reduces pollution by releasing fewer chemicals into the environment. Recycling also saves energy, as reprocessing chemicals like benzene requires less energy than producing them from raw materials. This leads to lower greenhouse gas emissions, helping to combat climate change."This initiative underscores CIL's commitment to collaboration and innovation in addressing our customers' most pressing challenges," said Cliff Caldwell, CEO of CIL. "By recovering and re-enriching depleted benzene-d6, we create a circular economy approach that is both economically and environmentally sustainable. As the world's largest supplier of benzene-d6, we are uniquely positioned to deliver this groundbreaking service."CIL's benzene recovery program is the result of 12 months of dedicated development, expansion, and rigorous testing to ensure reliable capacity and uncompromising quality. CIL invites interested parties to inquire about the program's details and how to participate.About Cambridge Isotope Laboratories, Inc.CIL is the world's largest manufacturer and global supplier of stable isotopes and stable isotope-labeled compounds used in research, environmental, pharmaceutical, medical diagnostic, OLED, and industrial markets. CIL subsidiary ABX, located in Dresden, Germany, is active in the development and commercialization of radio isotopic-labeled compounds for the diagnosis and treatment of cancers. CIL is an operating business owned by Otsuka Pharmaceutical. The CIL business consists of two facilities in the Boston, MA, area; a large isotope-enrichment production plant in Xenia, OH; CIL China; CIL Canada; ABX in Dresden, Germany; and Eurisotop in Saclay, France. For more information on CIL, visit isotope.com.Contact InformationCrissy Krisko [email protected]1.978.269.1930 SOURCE: Cambridge Isotope Laboratories, Inc.

100 Deals associated with ABX advanced biochemical compounds GmbH

100 Translational Medicine associated with ABX advanced biochemical compounds GmbH

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Pipeline Snapshot as of 05 Feb 2026

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

18F-PSMA-1007 ( PSMA )	Adenocarcinoma of prostate More	Phase 3
[99mTc]TcO-ABX474 ( PSMA )	Prostatic Cancer More	Preclinical
18F-Fluorocholine	Recurrent Prostate Carcinoma More	Pending
68Ga-PSMA-TM (ABX) ( PSMA )	Prostatic Cancer More	Pending
[11C]Me-HAPTHI	Myocardial Infarction More	Pending

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