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.
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SOURCE Galvanize Therapeutics, Inc.