Amorphical has enrolled the first participant in a Phase II clinical trial assessing its nano-amorphous mineral-based therapy for stage IV pancreatic cancer.
The study received approval from the Israel Ministry of Health and the Helsinki Committee of Shaare Zedek Medical Center.
It will assess the therapy’s effect on response rate (ORR), overall survival (OS), progression-free survival (PFS), and changes in participant quality of life using a dedicated questionnaire. Results are anticipated in the third quarter (Q3) of 2026.
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Globally, around 496,000 pancreatic cancer cases are identified annually, with the overall five-year survival rate at under 13% and only 3% for stage IV subjects.
Amorphical’s technology aims to buffer the tumour microenvironment selectively, thereby potentially restoring immune function, minimising the aggressiveness of tumour and improving responses to current treatments.
This Phase II trial follows Amorphical’s preclinical studies and earlier clinical research in other diseases, which showed the therapy’s capacity to modulate pathological acidity integral to tumour progression.
Shaare Zedek Medical Center gastrointestinal tumors service director and lead investigator Dr Ofer Purim said: “Given the urgent need for new therapeutic approaches in pancreatic cancer, we are proud to be leading this important study.
“Our goal is to investigate whether Amorphical’s nano-amorphous mineral-based therapy can extend patient survival and improve quality of life for those with this aggressive disease.”
Amorphical CEO Eden Ben said: “First patient enrolment in this trial marks an important milestone for Amorphical and for patients battling one of the toughest cancers.
“Our vision is to harness the unique properties of our nano-amorphous mineral technology to address the acidic tumour microenvironment, with the ultimate goal of extending life for patients with stage IV pancreatic cancer.”
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