Contact Information: Delcath Systems, Inc. Contact Mr. Richard Taney President & Chief Executive Officer T: (212) 489-2100 E: Investor Relations Contact Mr. Cass Almendral Vice President Strategic Growth International, Inc. T: 212-838-1444 E:
Delcath Systems Announces Clinical and Regulatory Appointments
New Executives Add Experience With FDA Approvals
| Source: Delcath Systems, Inc
NEW YORK, NY--(Marketwire - July 17, 2008) - Delcath Systems, Inc. (NASDAQ : DCTH ) announced
today the addition of two senior executives as the Company accelerates its
Phase III clinical trial towards completion. Mark Morrison, M.D., Ph.D.
joins Delcath as Chief Medical Officer to oversee the expansion of clinical
activity of the Company's first Phase III clinical trial. He replaces Dr.
Seymour Fein in this position. Mr. John Talarico joins Delcath in the
newly created position of Senior Vice President Regulatory Affairs and
Quality Systems.
Commenting on the new additions, Richard L. Taney, President and Chief
Executive Officer of Delcath, said, "As we move towards US FDA approval, we
continue building a senior team capable of addressing all phases of product
development and commercialization. Both of these individuals are veterans
in their fields and bring extensive and impressive experience in oncology
drugs and devices. The additions of Dr. Morrison and Mr. Talarico will
greatly help Delcath advance the Percutaneous Hepatic Perfusion (PHP)
System from the clinic to expanded commercial use. The team at Delcath is
excited to be working with Mark and John. We look forward to continuing to
build the Company, reach our milestones and propel Delcath forward."
CHIEF MEDICAL OFFICER -- MARK MORRISON, M.D., PH.D.
Board Certified in Medical Oncology and Internal Medicine, Dr. Morrison
brings broad experience in clinical research of both drugs and devices.
Dr. Morrison earned his M.D. and Ph.D. from the Mt. Sinai School of
Medicine in New York City, where his thesis explored the potential targeted
therapy of melanoma. Following his internship and residency at Beth Israel
Medical Center and Fellowship in Medical Oncology at Memorial
Sloan-Kettering Cancer Center (MSKCC), Dr. Morrison remained as an
instructor in the Clinical Immunology Service, Melanoma Group at MSKCC.
Dr. Morrison began his career in the pharmaceutical industry with American
Cyanamid, where he served as Clinical Team Leader, with a primary focus on
the development of therapies with monoclonal antibody conjugates. He
subsequently spent twelve years at Pfizer, beginning in New Product
Development, where his role encompassed both clinical trial conduct and
market analysis, leading to the development of comprehensive product life
cycle plans for Pfizer's Oncology pipeline. Dr. Morrison then moved to the
Medical Affairs division where he led the post-marketing clinical
development of the chemotherapy Camptosar™ (irinotecan). Most recently
at Pfizer, Dr. Morrison created and headed a team focused specifically on
optimizing the clinical development of new drug and device products. Dr.
Morrison's career also has included the position of Senior Director,
Medical Affairs and Oncology Medical Section Director, overseeing strategic
planning and the conduct of Oncology clinical trials to lead to regulatory
approvals at i3 Research, a global Clinical Research Organization.
SENIOR VICE PRESIDENT REGULATORY AFFAIRS AND QUALITY SYSTEMS -- MR. JOHN
TALARICO
Mr. Talarico recently held a similar title at Excelsior Medical and
ProRhythm, Inc., manufacturers of Class II and III combination products
involving a drug and device. He has held senior engineering, quality and
regulatory roles at a series of medical device companies, during which time
he was responsible for PMA, IDE and 510(k) submissions. Besides numerous
FDA approvals, Mr. Talarico has also been successful in gaining
international device approvals including the European CE Mark. He has
managed worldwide clinical trials for numerous products and directed the
QA, regulatory and compliance activities through approval and
commercialization.
ABOUT DELCATH SYSTEMS, INC.
Delcath Systems is a developmental stage company testing its percutaneous
perfusion technology for the isolated delivery of high doses of therapeutic
and chemotherapeutic agents. The Delcath System is currently being tested
in Phase III and Phase II clinical trials for the treatment of
hepatocellular carcinoma and metastatic tumors in the liver, including
melanomas, neuroendocrine tumors and adenocarcinomas. The Company's
intellectual property portfolio currently consists of twenty-eight patents
on a worldwide basis including the U.S., Europe, Asia and Canada. For more
information, please visit the Company's website at www.delcath.com.
The 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
successfully complete Phase III clinical trials and secure regulatory
approval of our current or future drug-delivery system 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.