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(EMAILWIRE.COM, April 01, 2010 ) New York, NY - TapeBeat.Com the news and research portal for the serious investor has been taking notes on Delcath Systems, Inc. (Public, NASDAQ:DCTH) since Feb. when DCTH announced data analysis should be complete sometime in April, 2010 on itÂ’s clinical study. Should primary endpoints be met, DCTH has made comments that an NDA would be submitted, as early as April. Following these statements by the company, the price per share has surged.
Decath initialized clinical trials on its system in 2006 for its PHP delivery system to treat patients with metastatic ocular and cutaneous melanoma in the liver. The drug the system utilizes for this treatment is Melphalan, and the study runs this drug parallel to other patients receiving best available care as a reference point for efficacy. The Phase III trial is being undertaken under a Special Protocol Assessment (SPA) and was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The National Cancer Institute is leading the study which has been granted Fast Track designation for the treatment of hepatic tumors secondary to melanoma and Delcath has been granted four orphan drug designations for its delivery stem. On March 16th, the company gave an update on its progress stating “the next operational milestone for our company is the April completion of data analysis from our Phase III trial,” said Mr. Eamonn P Hobbs, Delcath Systems president and CEO. “The trial’s data analysis involves the initial review by the principal clinical investigators at each enrolling center, an additional review by the Company’s retained Clinical Research Organization, and a final review of medical images for verification of results conducted by an independent core lab before final statistical results are compiled by an independent biostatistical group. We remain highly confident that the trial’s data will meet the trial’s primary endpoint, and our confidence was recently further buoyed by the FDA’s acknowledgement of an expanded access program,” added Mr. Hobbs.
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Stephen Ramey
Philip Runfeldt
Staff Writers
Mr. Ramey is long DCTH
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