PharmaMar Announces The Initiation Of Phase II Studies With Irvalec®

Main Category: Lung Cancer
Also Included In: Clinical Trials / Drug Trials
Article Date: 26 Dec 2008 - 1:00 PDT

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PharmaMar, a biotechnology company from Zeltia Group, announces the initiation of a Phase II multicenter study of Irvalec® in patients with non- microcitic 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 tumors, 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.

About Irvalec®

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 tumors, as well as an acceptable non- clinical 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

About PharmaMar

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. PharmaMar has four novel compounds in clinical development. Yondelis® has received Authorization for Commercialization from the European Commission for treating advanced soft tissue sarcoma. Yondelis® is currently being marketed in the European Union for the treatment of soft tissue sarcomas in adults after failure of standard therapy. Aplidin®, Zalypsis®, and Irvalec® are other marine-derived new agents in clinical development by PharmaMar, which also has a rich pipeline of preclinical candidates, and a strong R&D program.

You can find this press release at http://www.pharmamar.com and http://www.zeltia.com

Source:
Fernando Mugarza
PharmaMar

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