Asahi Kasei Pharma has started trial drug administration in a Phase III study of ART-123 in Japan for the prevention of chemotherapy-induced peripheral neuropathy related symptoms. This announcement follows encouraging data from earlier Phase I and II studies performed in Japan on the efficacy of ART-123 in relieving patient symptoms without compromising existing treatment plans.
Chemotherapies such as platinum-based drugs, taxanes, and vinca alkaloids are known to induce peripheral neuropathy. This condition, known as CIPN, is characterized by tingling and pain in the hands and feet, which, when severe, can impair day-to-day activities. In some cases, reduced dosage or suspension of chemotherapy may be necessary to alleviate symptoms, leading to a clinical effect on the patient’s prognosis. There are currently no drugs showing clear, established effectiveness for the prevention or treatment of CIPN, leaving patients with limited, often undesirable options.
Health Technology Insights: Aqueous Health Invests in Principle Diagnostics to Build Leading Diagnostic Services Company
ART-123 is a recombinant human thrombomodulin (rTM) approved in Japan in 2008. Previous Phase I and II studies suggest efficacy and patient tolerability of ART-123 for CIPN by suppressing the activation of protein C and thrombin-activable fibrinolysis inhibitor (TAFI). After consultation with Japan’s Pharmaceuticals and Medical Devices Agency (PDMA) regarding potential clinical development, Asahi Kasei Pharma initiated the Phase III study. The study will assess the efficacy and safety of ART-123 for CIPN in patients diagnosed with colorectal cancer and undergoing chemotherapy including the platinum drug oxaliplatin.
Health Technology Insights: Lunit and Microsoft Collaborate to Advance AI-Driven Cancer Diagnosis
“Patients undergoing chemotherapy still have no options for preventive or therapeutic drugs with clearly demonstrated efficacy for CIPN, leaving a significant unmet medical need worldwide,” said Yoshikazu Aoki, President, Asahi Kasei Pharma Corporation. “Limited treatment options for CIPN have made an already difficult situation even harder, leaving many patients and healthcare providers feeling discouraged as they seek ways to manage this challenging condition. We believe ART-123 could offer a new path forward in addressing this challenge and bringing solutions for patients on a global scale.”
This is in line with Asahi Kasei’s Medium-Term Management Plan, which targets high growth in the Healthcare sector with pharmaceuticals identified as a ‘First Priority’ area in its strategic positioning.
Health Technology Insights: symplr Acquires AMN Healthcare’s Smart Square To Enhance AI Workforce Optimization
To participate in our interviews, please write to our HealthTech Media Room at sudipto@intentamplify.com
Source – businesswire
