The National Cancer Institute (NCI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), both part of the National Institutes of Health (NIH), have commenced a Phase II clinical trial to investigate Pentixapharm's radioactive tracer, [68Ga]Ga-PentixaFor, for enhanced identification of functional adrenal tumors via positron emission tomography (PET) scans. This investigator-initiated study, endorsed by the FDA and conducted in the US, aims to enroll 77 patients.
Trial Details and Objectives
Led by Dr. Liza Lindenberg and Prof. Dr. Peter Choyke, the trial (NCT06246357) will evaluate PentixaFor's efficacy in subtyping hormone-secreting adenomas in individuals with primary aldosteronism (PA) or hypercortisolism (Cushing’s syndrome). The trial has dosed its first patient.
Clinical Significance
Primary aldosteronism is a prevalent cause of secondary hypertension, affecting millions in the United States. Accurate subtyping is crucial as certain PA subtypes can be resolved through surgical intervention. Cushing’s syndrome, or hypercortisolism, is a rare endocrine disorder where the body's tissues are exposed to excessive cortisol levels.
Pentixapharm's Broader Strategy
Pentixapharm is advancing its own US-based Phase III pivotal study to secure marketing approval for PentixaFor in primary aldosteronism. The NCI/NIDDK trial is expected to bolster the existing clinical evidence for PentixaFor.
Executive Perspective
Dr. Dirk Pleimes, Group CEO and Chief Medical Officer at Pentixapharm, expressed enthusiasm for the NIH's independent investigation, viewing it as a validation of CXCR4-targeted imaging's potential in unexplored indications. He highlighted PentixaFor's broad potential as a novel imaging modality for adrenal diseases, particularly beneficial for individuals with primary aldosteronism-induced resistant hypertension or Cushing’s disease.
About PentixaFor
PentixaFor (Gallium (68Ga) boclatixafortide) is a PET tracer targeting the chemokine-4 receptor (CXCR4), with applications in oncology, cardiovascular, and inflammatory diseases. In hypertension, PentixaFor offers the potential to improve patient management by identifying hormone-secreting adenomas through PET/CT imaging.
Pentixapharm's Pipeline
In addition to PentixaFor, Pentixapharm's pipeline includes PentixaTher, an Yttrium-90 or Lutetium-177 based therapeutic for non-Hodgkin lymphomas (NHL). Clinical studies are underway in Europe for both compounds, including a dose-finding study for PentixaTher and a Phase III registration study for PentixaFor in marginal zone lymphoma. The EMA recently granted PRIME status to PentixaFor for primary aldosteronism.
