Delcath Systems Inc (NASDAQ:DCTH) Shares Jump on SPA with FDA

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Delcath Systems Inc (NASDAQ:DCTH) shares were up 13.33% on Monday to $0.102 and an additional 7.84% in after-hours trading. The company has a market cap of $4.13 million at 40.05 million shares outstanding. Share prices have been trading in a 52-week range of $0.08 to $6.85.

Delcath Systems Inc is a late-stage clinical development company with early commercial activity in Europe focused on cancers of the liver. The company is a specialty pharmaceutical and medical device company developing its product, Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS).

Its system delivers and filters melphalan hydrochloride, which is marketed as a device under the trade name Delcath Hepatic CHEMOSAT Delivery System for Melphalan (CHEMOSAT). The company’s focus is on the execution of the clinical development program (CDP) in ocular melanoma liver metastases (mOM), intrahepatic cholangiocarncinoma (ICC), hepatocellular carcinoma (HCC or primary liver) and other cancers that are metastatic to the liver.

In a press release, Delcath Systems Inc shared that it has reached a Special Protocol Assessment with the U.S. Food and Drug Administration for the design of their trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System to treat patients with intrahepatic cholangiocarcinoma. This agreement indicates that the pivotal trial design adequately addresses objectives that, if met, would support regulatory requirements for approval of Melphalan/HDS.

“We look forward to initiating this important study in ICC under a SPA with the FDA,” said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath Systems Inc. “The promising outcomes and observations in this tumor type identified by European investigators at our global Key Opinion Leader Forum last year were discussed at length with the agency, and provide us with considerable confidence in the potential of our therapy as a treatment for ICC. A manuscript of the European investigator data will be submitted to a peer-reviewed journal for publication.”

The pivotal trial is titled A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) in Patients with Intrahepatic Cholangiocarcinoma.”  It will nroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe.

“This pivotal study in ICC is designed to be cost effective and pursued in a financially prudent manner.  Given the sequential nature of the trial design, Delcath’s investment in this study will be modest in 2017 as the Melphalan/HDS segment of the study will not occur until late in the year,” added Dr. Simpson.

The primary endpoint is overall survival and secondary and exploratory endpoints include safety, progression-free survival, overall response rate and quality-of-life measures. Delcath Systems Inc expects to initiate the study this fall.

In the same press release, the company announced that it intends to file financial results for the three and 12 months ending December 31, 2016 on Form 10-K with the U.S. Securities and Exchange Committee on or before March 30, 2017.

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