4SC's Partner Yakult Honsha Completes Phase I Part of Clinical Study with Resminostat in NSCLC Patients
4SC AG has announced that its Japanese partner Yakult Honsha Co., Ltd. has successfully completed the Phase I part and initiated the randomized Phase II part of a clinical Phase I/II study which evaluates 4SC's epigenetic cancer compound resminostat in combination with the cancer drug docetaxel as a potential novel second- and/or third-line therapy of advanced Asian NSCLC patients.
In the dose escalation Phase I part in nine Asian patients with advanced, metastatic, or recurrent NSCLC who have previously received one platinum-based chemotherapy, the resminostat/docetaxel combination proved to be safe and well tolerated in all dose levels tested. This is a key prerequisite of the further clinical development of the resminostat/docetaxel combination in this patient group.
Upon the positive Phase I results, the randomized Phase II part has started. It will compare the efficacy of docetaxel alone - a standard chemotherapeutic regimen for NSCLC - with the combination therapy of resminostat and docetaxel in the enrolled NSCLC patients. The primary endpoint of the Phase II part is progression-free survival (PFS), secondary endpoints include response rate (RR), overall survival (OS), and safety.
Enno Spillner, Chief Executive Officer of 4SC, said: "We are delighted that our partner Yakult Honsha has completed the Phase I part of the NSCLC study confirming once again the clean safety profile of our epigenetic agent resminostat when administered in combination with a classical anti-cancer drug. Lung cancer is the leading cause of cancer-related mortality around the world. Following the development progress of resminostat in this indication of high medical need is exciting. We very much appreciate the great enthusiasm of our Japanese partner in the development of resminostat."