Galvanize Therapeutics Completes Enrollment in Clinical Trial Evaluating Aliya® Pulsed Electric Field (PEF) System for Late-Stage Non-Small Cell Lung Cancer and Metastasis to the Lung

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Aug 06, 2024, 07:00 ET

REDWOOD CITY, Calif., Aug. 6, 2024 /PRNewswire/ -- Galvanize Therapeutics, Inc., a leader in developing pulsed electric field therapies for chronic bronchitis and solid tumors, has completed enrollment in the AFFINITY study evaluating Aliya PEF ablation in patients with stage IV non-small cell lung cancer (NSCLC) or metastasis to the lung who are not surgical candidates. The 30-patient study is examining the safety of adding Aliya PEF, delivered either bronchoscopically or percutaneously, to standard of care therapies for these advanced disease patients and further assessing immune stimulation and treatment effect.

"Completing enrollment in AFFINITY is a significant milestone towards our goal of providing patients with solid tumors a biology-based therapy that extends beyond focal ablation," said Jonathan Waldstreicher, M.D., Founder and CEO of Galvanize Therapeutics. "We look forward to reporting the results next year."

Aliya delivers high voltage, short duration electrical energy locally to alter the transmembrane potential of cells, which results in loss of homeostasis, inducing non-thermal programmed cell death without denaturing cellular proteins and the extracellular matrix. In addition to focal ablation, preclinical and prior clinical feasibility studies suggest this process may release antigens from the dying tumor cells that may stimulate an immune response for a potential systemic effect beyond focal ablation. Aliya can be delivered percutaneously or endoscopically with the new INUMI™ Flex needle. To date over 1,000 patients have been treated commercially and in clinical trials in the US using Aliya PEF.

"I'm excited to see the study results for this new technology", said David DiBardino, MD, Associate Director of Clinical Research, Section of Interventional Pulmonology and Associate Professor of Clinical Medicine, Pulmonology, Allergy, and Critical Care at University of Pennsylvania, and investigator in the AFFINITY trial. "It's great to be able to diagnose and ablate in the same procedure, however the added potential to stimulate the patient's immune system to create a systemic response represents a breakthrough for patients with metastatic disease."

The Aliya PEF System and the INUMI Flex needle are 510(k) cleared in the United States for the surgical ablation of soft tissue. They are not currently commercially available in any other geography.

About Galvanize™

Galvanize aims to become the global leader in delivering medical technology innovations that drive biologic processes to treat a range of diseases, including solid tumors, and chronic bronchitis symptoms. Formed by ATP (Apple Tree Partners), Galvanize is based in Redwood City, Calif., and is developing and commercializing its revolutionary Aliya® PEF energy platform in the United States. For more information, please visit www.galvanizetx.com.

SOURCE Galvanize Therapeutics, Inc.