delcath systems inc (DCTH) Key Developments
Delcath Receives Orphan Drug Designation from FDA for Melphalan to Treat Cholangiocarcinoma
Jul 20 15
Delcath Systems, Inc. announced that the U.S. Food and Drug Administration(FDA) Office of Orphan Products Development
(OOPD) has granted Orphan Drug Designation for melphalan for the treatment of cholangiocarcinoma. The OOPD is tasked with evaluating the scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products. Intrahepatic cholangiocarcinoma (ICC), a sub-category of cholangiocarcinoma, is a tumor in the bile duct that arises within the liver.Â It is the second most common primary liver tumor and represents approximately 15% of new HCC cases diagnosed annually. Surgical resection, the standard of care, is not possible for an estimated 80% to 90% of patients diagnosed with ICC. The Company recently announced the expansion of its global Phase 2 clinical study in primary liver cancer (HCC) to include an ICC cohort, which is investigating the safety and efficacy of Melphalan/HDS treatment in patients with unresectable ICC confined to the liver. The study is being conducted at the same hospitals in Europe participating in the Company's Phase 2 HCC trial, and is expected to enroll 11 patients. The ICC cohort will evaluate tumor response (objective response rate) as measured by modified Response Evaluation Criteria in Solid Tumor (mRECIST), and will assess progression-free survival and safety. Additional analyses will be conducted to characterize the systemic exposure of melphalan administered by Melphalan/HDS, as well as to assess patient-reported clinical outcomes, or quality-of-life.
Delcath Systems, Inc. Approves the Appointment of Grant Thornton, LLP as Independent Registered Public Accounting Firm for the Year Ending December 31, 2015
Jun 11 15
Delcath Systems, Inc. approved the appointment of Grant Thornton, LLP as the company's independent registered public accounting firm for the fiscal year ending December 31, 2015 at its AGM held on June 10, 2015.
Delcath Systems, Inc. - Shareholder/Analyst Call
Jun 5 15
Annual Meeting of Shareholders
Delcath Systems, Inc. Names Dr. Jennifer Simpson as its President and Chief Executive Officer
May 26 15
Delcath Systems, Inc. announced that Jennifer Simpson, Ph.D., M.S.N., C.R.N.P. has been named President and Chief Executive Officer by the company's Board of Directors, effective immediately. Dr. Simpson has served as Interim President and Chief Executive Officer of Delcath since September 2014 and as Interim Co-President and Co-Chief Executive Officer from September 2013 to September 2014. She joined Delcath in 2012 as Executive Vice President, Global Marketing. Prior to joining Delcath. Dr. Simpson was Vice President, Global Marketing, Oncology Brand Lead at ImClone Systems, Inc. Dr. Simpson served as Vice President, Product Champion and from 2008 to 2009 as Associate Vice President, Product Champion for a late-stage asset at ImClone.
Delcath Systems, Inc. Reports Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2015
May 6 15
Delcath Systems, Inc. reported unaudited consolidated earnings results for the first quarter ended March 31, 2015. For the quarter, the company reported revenue of $444,000 compared to $310,000 a year ago. Operating loss was $3,708,000 compared to $5,059,000 a year ago. Net loss was $3,488,000 compared to $5,278,000 a year ago. Basic and diluted loss per share was $0.32 compared to $0.57 a year ago. Cash and cash equivalents as of March 31, 2015 were $18.5 million, compared with $20.5 million as of December 31, 2014. During the first quarter of 2015, net cash used in operating activities was $4.4 million.