* Expects to complete FDA submission in Q4
* Expects expedited approval process
* Shares slightly higher (Adds CFO comments, background, stock price)
LOS ANGELES, Sept 28 (Reuters) - 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)