2012-12-05 02:02:01 -
NEW YORK, December 4, 2012 -- Delcath Systems, Inc. (Nasdaq: DCTH) announced
today that it will host a webinar on Wednesday, December 5, 2012 at 5:00 p.m. ET
to discuss recent corporate developments, followed by an online question-and-
answer session. Participants will have the opportunity to submit questions to
management during the webinar. Select questions will be summarized and addressed
during the question-and-answer portion of the call.
The live webinar will be available on the Events & Presentations page on the
Investor Relations section of Delcath's website
at
www.delcath.com/investors/events/. Webinar participants may submit
questions electronically via the webinar interface. For those unable to listen
to the live webinar, an archived webinar replay will be available at
www.delcath.com/investors/events/ beginning approximately two hours after
the completion of the webinar and will be available for two weeks.
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical device company
focused on oncology. Delcath's proprietary system for chemosaturation is
designed to administer high dose chemotherapy and other therapeutic agents to
diseased organs or regions of the body, while controlling the systemic exposure
of those agents. The Company's initial focus is on the treatment of primary and
metastatic liver cancers. In 2010, Delcath announced that its randomized Phase
3 clinical trial for patients with metastatic melanoma in the liver had
successfully achieved the study's primary endpoint of extended hepatic
progression-free survival. The Company also completed a multi-arm Phase 2 trial
to treat other liver cancers. The Company obtained authorization to affix a CE
Mark for the Generation Two CHEMOSAT® delivery system for melphalan
hydrochloride in April 2012. The right to affix the CE mark allows the Company
to market and sell the CHEMOSAT system for melphalan hydrochloride in Europe. In
October 2012, the Company satisfied all of the requirements to affix the CE Mark
to the Hepatic CHEMOSAT Delivery System device for intra-hepatic arterial
delivery and extracorporeal filtration of doxorubicin, providing a regulatory
pathway for CHEMOSAT with doxorubicin hydrochloride injection for countries in
Asia that accept the CE Marking as part of their national regulatory
requirements. The Company has not yet received FDA approval for commercial sale
of its system in the United States. The Company's NDA has been accepted for
filing and substantive review by the FDA. For more information, please visit
the Company's website at www.delcath.com.
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: our ability to address the contents of the 74 Day
Letter from the FDA, timing of completion of the FDA's review of our NDA, the
extent to which the FDA may request additional information or data and our
ability to provide the same in a timely manner, acceptability of the Phase 1, 2
and 3 clinical trial data by the FDA, FDA approval of the Company's NDA for the
treatment of metastatic melanoma to the liver adoption, use and resulting sales,
if any, in the United States,adoption, use and resulting sales, if any, for the
CHEMOSAT system in the EEA, our ability to successfully commercialize the
chemosaturation system and the potential of the chemosaturation system as a
treatment for patients with primary and metastatic disease in the liver, market
acceptance of the Gen Two CHEMOSAT system in Australia and our ability to
commercialize the CHEMOSAT system in Australia, patient outcomes using the
Generation 2 system, approval of the current or future chemosaturation system
for other indications, actions by the FDA or other foreign regulatory agencies,
our ability to successfully enter into strategic partnership and distribution
arrangements in foreign markets including Australia and key Asian markets and
timing of the same, the initiation of clinical trials in key Asian markets with
the Hepatic CHEMOSAT Delivery System device for intra-hepatic arterial delivery
and extracorporeal filtration of doxorubicin and timing and results of the same,
approval of the Hepatic CHEMOSAT Delivery System device for intra-hepatic
arterial delivery and extracorporeal filtration of doxorubicin in key Asian
markets, patient outcomes using the Hepatic CHEMOSAT Delivery System device for
intra-hepatic arterial delivery and extracorporeal filtration of doxorubicin,
our ability to obtain reimbursement for the CHEMOSAT system, uncertainties
relating to the timing and results of research and development projects and
future clinical trials, and uncertainties regarding our ability to obtain
financial and other resources for any research, development 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..
Contact Information:
Investor Contact: Media Contact:
Doug Sherk/Gregory Gin Janine McCargo
EVC Group EVC Group
415-568-4887/646-445-4801 646-688-0425
DELCATH ANNOUNCES WEBINAR TO DISCUSS RECENT CORPORATE DEVELOPMENTS:
hugin.info/143764/R/1662601/538896.pdf
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(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Delcath Systems, Inc via Thomson Reuters ONE
[HUG#1662601]
