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PharmaMar initiates phase II studies of Irvalec

MadridTuesday, December 23, 2008, 08:00 Hrs  [IST]

PharmaMar, a biotechnology company from Zeltia Group, announces the initiation of a phase II multicenter study of Irvalec in patients with nonmicrocitic lung cancer. The study will test the therapy in patients who have undergone platinum based chemotherapy. Lung cancer is the main cause of death by cancer. There are different types of the disease. Each type has its own growth pattern and requires a specific treatment that may include chemotherapy, radiation and surgery. Irvalec, a new synthetic depsipeptide derived from the PharmaMar Development Program of marine origin compounds, is a new drug with antiproliferative activity against a wide range of tumours, including breast, colon, pancreas, lung and prostate. The recruitment of patients is expected to last 12 months. In the new phase II multicenter study, Irvalec will be administered as an intravenous infusion for 30 minutes every 3 weeks. The primary endpoint will be progression-free survival. In the phase I trials done with Irvalec, the compound showed an excellent safety profile. Irvalec is a new synthetic depsipeptide resulting from PharmaMar's internal investigation for obtaining derivatives of marine natural compounds. Preliminary in vitro studies identified Irvalec as a new antiproliferative drug demonstrating activity against a broad spectrum of tumour types: breast, colon, pancreas, lung and prostate, among others. Irvalec has been selected for clinical development based on its in vivo activity in xenograft human tumours, as well as an acceptable nonclinical toxicology profile. Irvalec has pharmacodynamic effects as a regulator of ErbB3 which serves as the basis to explore their therapeutic potential in combination with inhibitors of ErB TK and with monoclonal antibodies that bind to the surface receptor. PharmaMar is the world-leading biopharmaceutical company of the Zeltia Group, and is committed to advancing the treatment of cancer through the discovery and development of new marine-derived medicines.

 
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