Siemens Healthineers was granted a Breakthrough Device designation for the ADVIA Centaur ELF test by the U.S. Food and Drug Administration (FDA) in 2018


Image: Galectin Therapeutics signs agreement with Siemens Healthineers. Photo: Courtesy of Free-Photos from Pixabay.

Galectin Therapeutics, a developer of therapeutics that target galectin proteins, announced a collaboration agreement with Siemens Healthineers, a global leader in medical technology, in nonalcoholic steatohepatitis (NASH) and liver fibrosis. This collaboration allows Siemens Healthineers to use Galectin’s Phase 2 NASH-CX clinical trial to support regulatory filings of the ADVIA Centaur® Enhanced Liver Fibrosis (ELF)™ test.

This agreement will also provide Siemens Healthineers with access to future clinical and ADVIA Centaur ELF test data from Galectin Therapeutics’ planned Phase 3 NASH-RX clinical trial of belapectin (GR-MD-02) in the treatment of NASH liver cirrhosis without esophageal varices.

“That a company the caliber of Siemens Healthineers wants to leverage the data from our clinical trials speaks to the scientific quality and relevance of our Phase 2 trial,” said Harold Shlevin, Ph.D., president and CEO of Galectin Therapeutics. “While we are focused principally on the clinical development of our galectin-3 inhibitor to treat patients with NASH cirrhosis, we are pleased that our Phase 2 and future Phase 3 clinical data will otherwise help advance scientific research by providing data in support of a non-invasive test that offers the promise of monitoring progression and development of liver disease.”

Siemens Healthineers was granted a Breakthrough Device designation for the ADVIA Centaur ELF test by the U.S. Food and Drug Administration (FDA) in 2018. The FDA’s Breakthrough Devices program is intended to facilitate the development and expedite the review of breakthrough technologies to help patients gain more timely access to potentially effective treatment or diagnosis for life-threatening diseases for which no approved treatment exists.

If approved, the ADVIA Centaur ELF test, a simple blood test, would help clinicians better manage patients with chronic liver disease. The ELF test is designed to analyze results from three serum biomarkers, Hyaluronic acid (HA), Procollagen III amino-terminal peptide (PIIINP), and Tissue inhibitor of metalloproteinase 1 (TIMP-1), in an algorithm that provides a single unitless ELF score, which can help improve the prediction of NAFLD/NASH and chronic liver disease patients at risk of disease progression.1

“At Siemens Healthineers, we are focused on improving the patient experience through less invasive testing procedures and expanding precision medicine through more personalized treatment decisions,” said Dennis A. Gilbert, Ph.D., Head, Laboratory Diagnostics R&D. “Incorporating Galectin Therapeutics existing and future research will enhance our regulatory submissions for the clinical use of the ADVIA Centaur ELF test as a non-invasive tool in the management of patients with liver fibrosis, NAFLD, and NASH.”

Source: Company Press Release