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Delcath Systems Announces Clinical and Regulatory Appointments

SOURCE:

Delcath Systems, Inc

2008-07-17 07:00:00

Delcath Systems Announces Clinical and Regulatory Appointments

New Executives Add Experience With FDA Approvals

NEW YORK, NY–(EMWNews – 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.

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:

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