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Company to manufacture Percutaenous Hepatic Perfusion System there.
September 4, 2009
By: Editor
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Delcath Systems Inc. has signed a lease on a new 10,000-square-foot facility in Queensbury, N.Y., where it plans to manufacture its Percutaenous Hepatic Perfusion System.
The company anticipates hiring about 20 people at this facility by the end of the year to establish manufacturing, distribution, research and development capabilities.
“Queensbury is within the fabled upstate-New York region long known as ‘Catheter Valley,’” said Eamonn Hobbs, president and CEO of Delcath Systems. “Major medical device companies have located their catheter operations there for decades. As a result, the local labor force is well acquainted with the manufacturing requirements that Delcath will face as it ramps up to full-scale production of the PHP System. And I am personally very excited to be building this business in a region that I know so well.
The Delcath PHP System is currently being tested in a Phase III study for the regional delivery of melphalan to the liver to treat patients with metastatic cutaneous and ocular melanoma who have unresectable tumors in the liver. The system is designed to deliver significantly higher doses of anti-cancer drugs to a patient’s liver while minimizing entry of the drugs into the rest of the patient’s circulation. This isolation limits toxicities, which result from systemic chemotherapy treatments, according to the company.
Enrollment in the trial is expected by the end of October, with CE Mark approval and submission to the U.S. Food & Drug Administration slated for no later than mid-2010.
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