Innovation, Patient care / 08.05.2023
Recognized Australian Endocrine & Hypertension Center Joins International Groups with a Clinical Trial of PentixaPharm’s Primary Aldosteronism Lead Candidate

Following clinical investigations of hypertension specialists in the Netherlands, France, the United States, and China, the Monash Medical Center (Monash Health) and Hudson Institute in Melbourne, Australia, has commenced an investigator initiated clinical study with PentixaPharm’s novel lead compound [⁶⁸Ga]Ga-PentixaFor targeting CXCR4 (international nonproprietary name Gallium (⁶⁸Ga) boclatixafortide) for the imaging of aldosterone-producing adrenal adenomas. In collaboration with the Nuclear Medicine department at Monash Health and Melbourne’s Peter MacCallum Cancer Center, the study team recently treated six hypertensive patients to evaluate for a surgically curable form of primary aldosteronism.

Primary Aldosteronism (PA) refers to the hypersecretion of aldosterone, a hormone that increases blood pressure and consequently leads to high vascular morbidity including stroke and heart failure. The excess release of the hormone is often caused by overactive adrenal glands. If only one of the two human adrenal glands is affected (“unilateral aldosterone-producing adenoma” or “APA”), the patient can in many cases be cured. Surgeons just remove the affected adrenal gland. If both glands are affected (bilateral adrenal hyperplasia, BAH), this is not possible.

Finding out whether only one or both glands are affected, however, is difficult, because the diagnostic gold standard, adrenal vein sampling (AVS), is a labor intensive, expensive, and invasive surgical procedure. It also poses a high risk of failed or inconclusive results. For this reason, many APA patients remain undetected and hence undergo unnecessary and often harmful medication. The availability of an easy-to-use imaging compound that reliably identifies the APA-subtype in patients with aldosterone-mediated hypertension may be a game-changer in making treatment decisions for millions. It would most likely have a large impact on clinical practice and enable a large number of hypertension patients to be cured.

The aim of the Investigators in Melbourne is to use [⁶⁸Ga]Ga-PentixaFor as novel non-invasive PET imaging compound to distinguish between the subtypes in patients with visible adrenal adenoma(s) on CT scans. Assoc. Prof. Jun Yang, coordinating Principal Investigator of the clinical study explains: “Whilst we are tempted to blame the aldosterone excess on visible adrenal adenoma(s), these adenomas could very well be non-functioning. The Gallium-68 based radio-diagnostic compound promises to radically improve patient management by replacing the invasive and difficult to perform adrenal vein sampling (AVS) in determining the functionality of these nodules. This is an exciting prospect. Monash Medical Center has therefore decided to recruit 20 PA patients to validate the utility of the compound.”

“The visualization of the adrenal gland tumors by [⁶⁸Ga]Ga-PentixaFor will potentially improve the subtyping of PA and facilitate better treatment decisions. The study in Australia is in line with clinical activities in Europe and in the USA, which are supported by PentixaPharm. PET/CTs using [⁶⁸Ga]Ga-PentixaFor might enable more PA patients to receive the right therapy”, comments Dr. Hakim Bouterfa, co-founder of PentixaPharm GmbH and Chief Medical Officer at Eckert & Ziegler AG.

Eckert & Ziegler (ISIN DE0005659700, TecDAX), the owner of the rights to the underlying [⁶⁸Ga]Ga-PentixaFor PET compound, supports Monash Medical Center and other investigators worldwide by providing the diagnostic compound in exchange for access to clinical data.

[⁶⁸Ga]Ga-PentixaFor is being developed by Eckert & Ziegler's subsidiary PentixaPharm GmbH also as a superiorly sensitive diagnostic for a portfolio of hematooncological malignancies. For more information visit www.pentixapharm.com

About Eckert & Ziegler.
Eckert & Ziegler Strahlen- und Medizintechnik AG with more than 1.000 employees is a leading specialist for isotope-related components in nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.