drugset / Press release

Hanmi to initiate a Phase 1 clinical trial of HM95573, the next generation targeted therapy for melanoma treatment

2014-11-10 · Hanmi Pharmaceutical Company Limited · original hanmipharm.com ↗

제목 없음 Hanmi to initiate a Phase 1 clinical trial of HM95573, the next generation targeted therapy for melanoma treatment Hanmi Pharmaceutical (CEO: Gwan Sun Lee) announced on the 5th that it has submitted an investigational new drug application to the Korean Ministry of Food and Drug Safety (MFDS) to conduct a Phase 1 clinical trial of HM95573 in patients with solid tumors including melanoma. HM95573 is a potent and selective second-generation RAF inhibitor that inhibits mutated RAF and RAS proteins which contribute to tumor cell growth and proliferation, to treat patients who are unresponsive to or with unacceptable side effects induced by previous treatment. The Phase 1 trial will assess the safety and tolerance of HM95573 in patients with solid tumors to identify the maximum tolerated dose. Parameters including objective response rate, changes in tumor growth rate and disease control rate will also be evaluated in this clinical trial. Tumor responses will be observed in patients with B-RAF mutation, K-RAS mutation, and N-RAS mutant melanoma, colorectal cancer, hepatic cancer and non-small cell lung cancer. Jina Jung, Director of Clinical development at Hanmi, stated that “HM95573 is under development as a second-generation target therapy to treat patients who are unresponsive to previous treatment” and “Hanmi aims to develop innovative cancer treatments to meet the needs of cancer patients in pain”. Along with HM95573, Hanmi has HM61713, an EGFR-mutant selective inhibitor with potential antineoplastic activity, and Poziotinib, an EGFR inhibitor that blocks signal transduction, in its targeted cancer therapy pipeline in development. PREV The biggest R&D investment in 3Q, 22.4% of sales revenue LIST NEXT The new global anti-hypertension combination product ‘Amosartan’, obtained a patent in Japan

The release as fetched from its publisher. hanmipharm.com ↗