Delcath Announces Special Protocol Assessment Agreement With FDA for Pivotal Trial With Melphalan/HDS in Intrahepatic Cholang...
March 27 2017 - 8:00AM
Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology
Company focused on the treatment of primary and metastatic liver
cancers, announces it has reached a Special Protocol Assessment
(SPA) 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.
Full details of the registration trial will be
made public upon the launch of the study and will be available at
www.clinicaltrials.gov.
“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.
Separately, the Company announces 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.
About Special Protocol
Assessments 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.
About Intrahepatic
CholangiocarcinomaIntrahepatic 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.
About Delcath SystemsDelcath
Systems, Inc. is an interventional oncology Company focused on the
treatment of primary and metastatic liver cancers. Our
investigational product—Melphalan Hydrochloride for Injection for
use with the Delcath Hepatic Delivery System (Melphalan/HDS) —is
designed to administer high-dose chemotherapy to the liver while
controlling systemic exposure and associated side effects. We have
commenced a global Phase 3 FOCUS clinical trial for Patients with
Hepatic Dominant Ocular Melanoma (OM) and plan to initiate a
Registration trial for intrahepatic cholangiocarcinoma (ICC) in the
Fall of 2017. Melphalan/HDS has not been approved by the U.S. Food
& Drug Administration (FDA) for sale in the U.S. In
Europe, our system has been commercially available since 2012 under
the trade name Delcath Hepatic CHEMOSAT® Delivery System for
Melphalan (CHEMOSAT), where it has been used at major medical
centers to treat a wide range of cancers of the liver.
Private Securities Litigation Reform Act of 1995
provides a safe harbor for forward-looking statements made by the
Company or on its behalf. This news release contains
forward-looking statements, which are subject to certain risks and
uncertainties that can cause actual results to differ materially
from those described. Factors that may cause such differences
include, but are not limited to, uncertainties relating to:
the timing and results of the Company’s clinical trials
including without limitation the OM and ICC clinical trial
programs timely enrollment and treatment of patients in the
global Phase 3 OM clinical trial, , IRB or ethics committee
clearance of the Phase 3 OM and ICC Registration trial
protocols from participating sites and the timing of site
activation and subject enrollment in each trial, the impact of the
presentations at major medical conferences and future clinical
results consistent with the data presented, approval of Individual
Funding Requests for reimbursement of the CHEMOSAT procedure, the
impact, if any of ZE reimbursement on potential CHEMOSAT
product use and sales in Germany, clinical adoption, use and
resulting sales, if any, for the CHEMOSAT system to deliver and
filter melphalan in Europe including the key markets of Germany and
the UK, the Company’s ability to successfully commercialize the
Melphalan HDS/CHEMOSAT system and the potential of the Melphalan
HDS/CHEMOSAT system as a treatment for patients with primary and
metastatic disease in the liver, our ability to obtain
reimbursement for the CHEMOSAT system in various markets,, approval
of the current or future Melphalan HDS/CHEMOSAT system for delivery
and filtration of melphalan or other chemotherapeutic agents for
various indications in the U.S. and/or in foreign markets, actions
by the FDA or other foreign regulatory agencies, the Company’s
ability to successfully enter into strategic partnership and
distribution arrangements in foreign markets and the timing and
revenue, if any, of the same, uncertainties relating to the timing
and results of research and development projects, our ability to
maintain NASDAQ listing, and uncertainties regarding the Company’s
ability to obtain financial and other resources for any research,
development, clinical trials and commercialization activities.
These factors, and others, are discussed from time to time in our
filings with the Securities and Exchange Commission. You should not
place undue reliance on these forward-looking statements, which
speak only as of the date they are made. We undertake no obligation
to publicly update or revise these forward-looking statements to
reflect events or circumstances after the date they are made.
1 M. Tucker “Model Predicts Survival in
Intrahepatic Cholangiocarcinoma”
http://www.medscape.com/viewarticle/821759 (Accessed March 24,
2017)
Contact Information:
David Boral
Managing Director
CoreIR
Tel: 516 222 2560
Email: davidb@coreir.com