UPDATE 2-Delcath cancer system could get OK mid-2011 — CFO

* Expects to complete FDA submission in Q4

* Expects expedited approval process

* Shares slightly higher
(Adds CFO comments, background, stock price)

LOS ANGELES, Sept 28 (BestGrowthStock) – Delcath Systems Inc
(DCTH.O: ) expects to finish an application for U.S. review of
its cancer drug delivery system in the fourth quarter, which
would put it on track for approval by mid-2011, according to
the company’s chief financial officer.

Delcath in June presented pivotal trial results showing
that melanoma patients whose cancer had spread to their liver
survived for an average of 398 days before dying or having
their cancer get worse after treatment with the company’s
“Percutaneous Hepatic Perfusion” system.

Patients treated with standard drugs survived for an
average of 124 days before they died or their tumor growth
restarted.

“We believe we will be granted an expedited review,” CFO
Dave McDonald said during a Webcast presentation at an investor
meeting on Tuesday. “That puts us in mid-2011 for approval.”

Delcath’s system is designed to deliver high doses of the
generic chemotherapy drug melphalan directly to the liver via
the hepatic artery.

The system aims to minimize side effects by filtering the
highly toxic drug out of the blood stream as it leaves the
liver, but some of the drug leaks out.

Two of the 93 patients in the pivotal trial died as a
result of the treatment. A third death was attributed to the
fact that the patient had such advanced liver metastases that
he should not have been enrolled in the trial, McDonald said.

Delcath’s pivotal trial, in which patients were allowed to
cross over from standard treatment to the Delcath system, was
designed in concert with the FDA.

Referring to questions about whether the trial was rigorous
enough for final FDA approval of the drug, McDonald said the
agency “can do whatever the heck they want, but we don’t see
anything that suggests they won’t honor it.”

He estimated that around 15,000 U.S. melanoma patients
would be eligible for treatment with the Delcath system, which
would be equivalent to an annual market potential of around
$750 million.

Delcath is also studying use of the system in other types
of cancer.

The company’s shares were up 2 cents to $7.60 in afternoon
trading on Nasdaq.
(Reporting by Deena Beasley; editing by John Wallace)

UPDATE 2-Delcath cancer system could get OK mid-2011 — CFO