The prospective AFFINITY clinical trial is intended to prove the safety and technical success of the Aliya PEF System in patients having stage IV NSCLC or lung metastasis who are not eligible for surgeries
Galvanize Therapeutics starts the AFFINITY study of Aliya PEF system in the US in lung cancer patients. (Credit: kalhh from Pixabay)
Galvanize Therapeutics has announced the treatment of the first patient in the AFFINITY clinical study using the Aliya Pulsed Electric Field (PEF) system in certain lung cancer patients.
The US-based biomedical platform company has designed the Aliya PEF System to provide localised high voltage, short duration electrical energy with the aim of altering the cell’s transmembrane potential. This is said to result in loss of homeostasis and causes non-thermal programmed cell death without changing the nature of the extracellular matrix or cellular proteins.
The prospective AFFINITY clinical trial is intended to show the safety and technical success of the Aliya PEF System in patients having stage IV non-small cell lung cancer (NSCLC) or lung metastasis who are not eligible for surgeries.
The first procedure in the single-arm study was completed by pulmonology specialist Michael Pritchett using the Aliya Endobronchial Needle for the first time in the US through robotic-assisted bronchoscopy. The needle, which allows delivery via a bronchoscope, is an investigational device in the US.
Galvanize Therapeutics founder and CEO Jonathan Waldstreicher said: “Our team spent years developing Aliya PEF to synergise with immunotherapy and other standard-of-care therapies in order to provide patients with solid tumours a biology-based therapy that extends beyond what is possible with focal thermal ablation.
“The AFFINITY study represents a significant step towards treating a broad range of tumour types and in early and late-stage disease.”
The early feasibility study is being carried out at three facilities in the US.
It will feature up to 10 non-surgical stage IV NSCLC or lung metastases patients who are eligible for first-line standard of care therapy.
In the study, Aliya PEF will be delivered using either a bronchoscopic or percutaneous approach.
The trial will further evaluate the potential immunological modulation and therapeutic efficacy, as well as the safety of including Aliya PEF therapy in the care route for these advanced disease patients.
Aliya’s safety, viability, and ability to produce an immunological response were demonstrated in Galvanize Therapeutics’ INCITE-ES clinical study in NSCLC patients outside of the US.