Clinical trial application submitted to CTIS for first-in-class compound targeting cancer cell metabolism.
Lund, Sweden and Darmstadt, Germany — TFS HealthScience, a global full-service Contract Research Organization, and benfovir AG, a pharmaceutical company, today announced a collaboration following the submission of a Clinical Trial Application to the EU Clinical Trials Information System (CTIS). TFS has been selected to provide clinical research services for an early-phase clinical trial evaluating benfo-oxythiamine (B-OT) in combination with an established standard of care in patients with metastatic castration-resistant prostate cancer (mCRPC).
B-OT is a first-in-class transketolase inhibitor developed by benfovir AG that takes a different approach to treating cancer. Rather than targeting a specific genetic mutation, B-OT targets cancer cell metabolism. Cancer cells depend heavily on the pentose phosphate pathway to produce the building blocks they need to replicate and divide. The enzyme transketolase drives this process, and in many tumours it is overactive. B-OT is designed to block it, cutting off a metabolic resource that cancer cells need to proliferate.
Because this mechanism does not depend on a specific genetic profile, it has potential relevance across tumour types, which could open new options for patients who have few. A Phase I study in healthy volunteers has already demonstrated a favourable safety profile for B-OT. The trial announced today will evaluate the compound in a patient population for the first time, marking a significant step from preclinical science towards a potential new treatment.
At TFS we are proud to support this programme. It builds on our growing track record in early-phase oncology in Europe and reflects the kind of work our practice was built for: science-led, and grounded in understanding both the compound and the patients it could reach.
“Transketolase inhibition represents fundamentally new approach to targeting cancer cell metabolism. Moving B-OT into a patient population for the first time is a milestone for our programme. We selected TFS HealthScience for their specialist oncology expertise and operational reach across European clinical sites.”
Dr. Johannes Coy, CEO, benfovir AG
“What makes B-OT exciting is the ambition behind it: a completely new way of targeting cancer, not through a single mutation, but through the metabolism that fuels it. Taking this compound into patients for the first time is an important milestone in its clinical development.”
Estelle Guiheneuf, Interim Operational Head of Oncology, TFS HealthScience
About benfovir AG
Benfovir AG is a clinical-stage pharmaceutical company headquartered in Darmstadt, Germany, focused on developing novel therapies based on transketolase inhibition. By targeting the pentose phosphate pathway, benfovir’s approach aims to disrupt metabolic processes exploited by viral replication, inflammation and cancer cell proliferation. The company’s lead compound, benfo-oxythiamine (B-OT), is a first-in-class transketolase inhibitor that has completed Phase I clinical testing in healthy volunteers. benfovir partners with Oxy5 Oncomedical AG for the clinical development of B-OT in oncology.
For more information, visit benfovir.com.
About TFS HealthScience
TFS HealthScience is a full-service, global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance innovative treatments and improve patient outcomes. With over 500 professionals operating across 40 countries, TFS delivers tailored clinical research services in specialised therapeutic areas, including dermatology, internal medicine, neuroscience, oncology and ophthalmology. Dedicated to empowering partners and enriching lives, TFS offers flexible clinical development and resourcing solutions that combine global reach with the agility and responsiveness of a mid-sized CRO. For more information, visit www.tfscro.com.
For more information, visit www.tfscro.com.
Media contacts
TFS HealthScience:
Paloma Redondo,
Director Marketing & Communication
marketing@tfscro.com
Benfovir AG:
Kathrin Riepe
Head of Clinical Development
riepe@benfovir.com
This press release contains statements regarding the future development of investigational products. Such statements are based on current expectations and are subject to risks and uncertainties associated with clinical development and regulatory review