Delcath Systems, Inc. (Nasdaq: DCTH), a Manhattan headquartered medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced that it has signed a three-year lease with the option to buy on a 10,000 square foot facility in Queensbury, New York in which it plans to locate manufacturing of its Percutaneous Hepatic Perfusion (PHP(TM)) System. The company anticipates hiring approximately 20 people at this facility by the end of 2009 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(TM). And I am personally very excited to be building this business in a region that I know so well.”
The Delcath PHP System(TM) is presently 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.
Complete enrollment in the trial is expected by the end of October 2009, with CE Mark approval and a submission to the U.S. Food & Drug Administration by mid-2010. Pending CE Mark approval, the Queensbury facility, located at 566 Queensbury Avenue, could be distributing product outside the USA by early 2010.