Amorphical Announces First Patient Enrolled in Phase 2 Clinical Trial of Nano-Amorphous Mineral-Based Therapy in Stage IV Pancreatic Cancer Patients

Novel Platform Aims To Normalize Tumor Acidity, Slow Disease Progression and Extend Survival

NES ZIONA, Israel, Nov. 24, 2025 /PRNewswire/ -- Amorphical, developer of nano-amorphous mineral-based pharmacologic agents for health conditions, today announced that the first patient has been enrolled in its Phase 2 clinical trial evaluating the company's investigational nano-amorphous mineral-based therapy in patients with Stage IV pancreatic cancer. The study, approved by the Helsinki Committee of Shaare Zedek Medical Center and the Israel Ministry of Health, aims to investigate whether this therapy can extend the survival of these patients by time to progression (PFS), overall survival (OS), response rate (ORR), and change in quality of life using a dedicated questionnaire. Data is expected in Q3 of 2026.

Pancreatic cancer is one of the deadliest forms of cancer with an estimated 496,000 cases diagnosed globally each year. With limited treatment options, the overall five-year survival rate is less than 13%, dropping to just 3% for Stage IV patients. Tumor acidity is a hallmark of advanced pancreatic cancer and plays a central role in immune evasion, metastasis, and resistance to therapy. Amorphical's proprietary nano-amorphous mineral technology is designed to selectively buffer the tumor microenvironment, potentially restoring immune activity, reducing tumor aggressiveness, and enhancing responses to standard treatments.

"Given the urgent need for new therapeutic approaches in pancreatic cancer, we are proud to be leading this important study," said Dr. Ofer Purim, Director of the Gastrointestinal Tumors Service at Shaare Zedek Medical Center and the study's lead investigator. "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."

This Phase 2 trial builds on Amorphical's extensive preclinical research and early clinical data from other indications, which have demonstrated the technology's ability to modulate pathological acidity - a key factor in tumor growth.

"First patient enrollment in this trial marks an important milestone for Amorphical and for patients battling one of the toughest cancers," said Eden Ben, Chief Executive Officer of Amorphical. "Our vision is to harness the unique properties of our nano-amorphous mineral technology to address the acidic tumor microenvironment, with the ultimate goal of extending life for patients with Stage IV pancreatic cancer. We are deeply grateful to the clinical teams and patients who are making this progress possible."

With more than a decade of real-world exposure through early access and compassionate use programs, Amorphical enters clinical development with valuable safety and tolerability insights to guide its regulatory pathway. In addition to pancreatic cancer, the company is advancing clinical programs in hypoparathyroidism, Crohn's disease, and osteoporotic fractures. The company's platform is protected by more than 190 patents worldwide.

About Amorphical

Amorphical is a biotechnology company advancing a new class of nano-amorphous mineral pharmacologic agents. Leveraging a proprietary, nature-inspired platform, Amorphical aims to address unmet needs in areas like pancreatic cancer, inflammatory diseases and metabolic disorders by enhancing bioavailability and optimizing pH balance at the cellular level. Supported by nearly 200 patents, extensive real-world exposure, and a GMP-certified manufacturing infrastructure, Amorphical is committed to bringing scientifically validated, disease-modifying mineral therapies to patients.
Learn more at www.amorphical.com and follow Amorphical on LinkedIn.

Media Contact: 
Ellie Hanson
FINN Partners for Amorphical
[email protected]
+1-929-588-2008

SOURCE Amorphical