Delcath Systems, Inc. (NASDAQ:DCTH) is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company has an investigational product (Melphalan Hydrochloride) for Injection for use with the Delcath Hepatic Delivery System, which is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. This is a specialized liver cancer stock that has had a spectacular June rallying from 2 cents to 36 cents so far this month, and it has exceeded historical volume levels all through the month. The odd thing is little or no news has crossed the wire of any real importance in June. However, the real picture is about the yearend trial and the enrollment of approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe.
This is a hefty upside move for shareholders as the value (marketcap) is now hovering near the 100 million mark, trading today at $98.06 million with 167.88 million shares outstanding.
Delcath Systems, Inc. (NASDAQ:DCTH) is focused on the treatment of primary and metastatic liver cancers. Back in April, DCTH said they reached a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA) for the design of Delcath’s pivotal trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with intrahepatic cholangiocarcinoma (ICC). The SPA agreement indicates that the pivotal trial design adequately addresses objectives that, if met, would support regulatory requirements for approval of Melphalan/HDS.
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.” Under the SPA, the study will enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe. The primary endpoint is overall survival (OS) and secondary and exploratory endpoints include safety, progression-free survival (PFS), overall response rate (ORR) and quality-of-life measures. The Company expects to initiate the study in the Fall of 2017.
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“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. “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.”
“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 Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a new drug application. Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 clinical program. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety.
Intrahepatic cholangiocarcinoma is the second most common primary liver tumor and represents approximately 10-20% of new hepatocellular carcinoma (primary liver cancer or HCC) cases diagnosed annually, or approximately 3,100 new cases every year in the U.S.1 Surgical resection, the standard of care, is not possible for an estimated 80% to 90% of patients diagnosed with ICC.
Delcath Systems, Inc. (NASDAQ:DCTH) heads into the 4th of July weekend on the back of a solid June rising more than 5 fold from that 2 penny bottom. They have done this on spectacular volume with very little news. Often in stocks like DCTH shares move before details of the trial emerge and according to previous press the company will be getting these underway soon. These will be real metrics for investors and analysts to chew on, but for the month of June 2017 these shares have been a stellar performer before they even begin. Hopefully for the DCTH shareholder the price is telling us good news in advance. For continuing coverage on shares of $DCTH stock, as well as our other breakout stock picks, sign up for our free newsletter now and get our next hot stock pick!