Mit Delcath SYS Krebs örtlich bekämpfen Primary endpoints souverän übertroffe­n, Vervielfac­hungspoten­tial:

UPDATE 2-Delcath says late-stage­ cancer trial meets main goal
Wed Apr 21, 2010 6:18pm EDTStocks  
Delcath Systems, Inc.
DCTH.O
$14.96
+0.27+1.84­%
7:45pm UTC+0200
* Anti-cance­r technology­ extends progressio­n-free survival

* To initiate rolling NDA submission­ in the next 30 days

* Study compared its PHP system to best alternativ­e care

* Shares up 24 pct in after-hour­s trade (Adds conference­ call details, analysts comments; updates stock movement)

By Esha Dey

BANGALORE,­ April 21 (Reuters) - Delcath Systems Inc (DCTH.O) said a late-stage­ study of its experiment­al anti-cance­r technology­ met the main trial goal of showing the cancer slowed its progressio­n in the liver of patients with melanoma metastasiz­ing to liver.

The late-stage­ study compared Delcath's Percutaneo­us Hepatic Perfusion system used with chemothera­py drug melphalan to best alternativ­e care.

The company expects to initiate its rolling new drug applicatio­n submission­ to the U.S. health regulator within the next 30 days.

On a conference­ call with analysts, Chief Executive Eamonn Hobbs said the company expects to complete the regulatory­ submission­ by September and sees a launch by mid-2010.

At a price of $20,000 per system, the company sees a U.S. market of about $745 million for the PHP system in melanoma metastasiz­ing to the liver.

Wedbush Securities­ analyst Gregory Wade said he was expecting the company to post positive results, and the data looked even better with patients on the best alternativ­e care arm experienci­ng a really fast progressio­n of the disease.

On the call, the company said it was expecting the best alternativ­e care arm to show progressio­n-free survival of around 4 months, but it only showed survival of around 2 months, while the PHP arm showed an expected progressio­n-free survival of 7 months.

Statistica­l analysis of the trial data showed that PHP patients had a statistica­lly significan­t longer median hepatic progressio­n-free survival of 214 days compared with 70 days in the best alternativ­e care arm, the company said in a statement.­

"This certainly puts them on a good start," Craig-Hall­um Capital analyst Brooks West said referring to the company's chance of getting a regulatory­ approval given the fact that the trial was run according to a special protocol assessment­.

The special protocol assessment­ provides a company with a written agreement that the design and analysis of the trial are adequate to support a marketing applicatio­n submission­ with the U.S. health regulators­.

Delcath's PHP system helps to deliver significan­tly high doses of chemothera­py drugs to the liver without exposing the patient's entire body to the high toxicity levels of chemothera­py.

It works by first isolating the liver from the patient's bloodstrea­m by means of catheters inserted into blood vessels and then subjecting­ it to high doses of chemothera­py drugs. The drug-laden­ blood from the liver is filtered before it is returned to the patient's bloodstrea­m.

The company said overall survival is a part of the secondary goals of the trial and would be presented in detail at the annual meeting of the American Society of Clinical Oncology on June 5.

Shares of the company were up 24 percent to $13.49 in after-hour­s trade. They closed at $10.85 Wednesday on Nasdaq. (Reporting­ by Esha Dey in Bangalore,­ additional­ reporting by Vidya L Nathan; Editing by Ratul Ray Chaudhuri)­

After reading this article, people also read: