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Delcath Systems (DCTH)

|Includes:Delcath Systems, Inc. (DCTH)

DCTH is at the front of regional treatment of cancer with a promising therapy to shrink tumors in the liver. Delcath’s Percutaneous Hepatic Perfusion (PHP™) technology allows physicians to deliver significantly higher doses of anti-cancer drugs to the liver without exposing the patient's entire body to those same potent levels of drug. PHP™ is an investigational treatment currently undergoing testing in Phase III and Phase II clinical trials.

administered via the hepatic artery and the venous effluent of the liver is collected and filtered using a percutaneously placed catheter and filtration system. The treatment is investigational, but observed benefits of the procedure include:

Minimally invasive – PHP™ utilizes a series of catheters and extracorporeal filters to infuse high doses of chemotherapeutic agents to tumors in the liver with minimal systemic exposure.

Higher Dosing – PHP™ allows infusion doses exceeding those of systemic or intra-arterial administration.

Treatment Flexibility - PHP™ can be performed in an operating room or in a radiology suite under local or general anesthesia.

Repeatable Procedure - Unlike surgical isolated hepatic perfusion (IHP), which can be performed only once, PHP™ can be repeated several times. Patients within the trial usually receive the treatment at four-week intervals and up to ten treatments have been administered to a patient.

Decreased Toxicity - Filtration of the hepatic venous effluent can reduce systemic exposure of chemotherapy by 80% to 90% compared to hepatic artery infusion alone.

Today, DCTH started to analyze Phase III data:

Company On Track For April 2010 FDA Submission

NEW YORK, Feb. 4 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary treatment system for metastatic cancers to the liver, announced today that sufficient events have been reached to allow data analysis to begin on its Phase III trial.  The trial uses the drug melphalan to treat patients with metastatic melanoma in the liver.  

"We remain very optimistic that the Phase III trial will achieve a successful endpoint," said Eamonn P. Hobbs, President and CEO of Delcath. "Assuming a successful trial endpoint, we remain committed to filing our NDA with the FDA in April," Mr. Hobbs added.

The 92 patient, randomized, multi-center, Phase III study commenced patient enrollment in February 2006.  Patients were randomly assigned to receive treatments with ultra-high doses of the chemotherapeutic drug melphalan infused directly into the liver via the Delcath PHP System™ or to a control group, where they were provided with best alternative care (NYSE:BAC).  BAC included alternative regional or systemic therapies.  Patients assigned to the Delcath arm were eligible to receive up to six cycles of treatment at approximately four to six week intervals.  Patients randomized to the non-PHP arm were permitted to cross-over into the Delcath arm at documentation of hepatic disease progression.

The study's primary objective was to demonstrate a statistically significant improvement in the hepatic progression free survival (HPFS) of patients with metastatic melanoma (ocular or cutaneous) to the liver treated with the Delcath PHP System™ versus patients in the control arm. Secondary endpoints include response rate, duration of response and overall survival.

DCTH Sequence of events from here on:

Data complete in February 2010

FDA submission April 2010

Endpoints are much more than double that of control group

Coincident with FDA submission, or maybe before, expect a paper published in JAMA or NEJM after all Trial Center heads (including NCI) unanimously agree on findings which will be a big event

Partnering discussions are being held in over 3 countries for exclusive geographic marketing rights and once the first agreement is established DCTH’s stock price will be moving north

Reference to active negotiations should not have been mentioned in Hobb’s November press release as its set up an expected time certain and a concomitant stream of worries for unsophisticated or impatient investors who assume “the negative” when no press release has been made according their own mental and unjustified timetable

Stock pressure is to be expected with some parties understandably cashing-in to lock in realized gains. Actually, weak hands are relinquishing to strong investors who are picking DCTH up for steal. Yes, downward stock movement is worrisome, but unjustified.

Nothing is wrong but the company wants to insure tight lips and DCTH will not issue a press release just to calm the price of its stock.

Expect a partner, either Asian or US, next year to expand on platform technology and expedite trials and front all costs for Hepatitis and Colorectal indications

When there is a release it will be legitimate and with positive news

Do your own homework, your money, your decision.

Stocks: DCTH