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Delcath Surges on Phase III Clinical Data

Written By Brian Hicks

Posted April 22, 2010

Delcath Systems (NASDAQ:DCTH) surged 30% in after-hours trading Wednesday. The company announced positive clinical data for their proprietary liver cancer treatment system, The Delcath Percutaneous Hepatic Perfusion (PHP) device.

The PHP system works by first isolating the patient’s liver from the rest of the circulatory system. This is accomplished using catheters and balloons, which are inserted via small incisions in the patient’s neck and legs. Highly-concentrated doses of chemotherapy drugs are then delivered directly to the diseased organ. After treatment, the blood is filtered and cleansed of potentially toxic drugs and returned to circulation.

The system — which is unique as far as I know — allows doctors to target the liver with 10x higher doses of chemotherapy than are normally feasible. Since the drugs are targeted directly at the tumors, then filtered out of the bloodstream after treatment, DCTH thinks they can significantly increase dosage without increasing toxicity. It could prove to be an important life-extending development for patients who currently have few treatment options.

The trial data announced this afternoon comes from Delcath’s phase III clinical trial, which enrolled patients who have melanoma that has spread to the liver.

Patients who received treatment from the Delcath system had more than a 50% reduction in a primary study goal, "time to tumor reduction or death". The results exceeded primary endpoint expectations and were statistically significant. In FDA-speak, that’s a good news for patients and investors.

Here’s an excerpt from the company’s press release:

Delcath Systems, Inc. (NASDAQ: DCTH), a development stage, oncology-focused, specialty pharmaceutical and medical device company, announced that its Phase III National Cancer Institute (NCI)-led multi-center clinical trial has successfully met the study’s primary endpoint of extended hepatic progression-free survival (hPFS) in patients with melanoma metastases to the liver based on an independently corroborated intent-to-treat analysis. Comparing treatment with the Delcath PHP System with melphalan to Best Alternative Care (BAC), based on independent core lab review of patient scans, the statistical analysis revealed that the PHP patients had a statistically significant longer median hPFS of 214 days compared to 70 days in the BAC arm.

Reuters reports that the market for Delcath’s system to treat melanoma which has spread to the liver could be $745 million in the U.S. alone. Delcath is also proceeding with phase II clinical trials on primary liver cancers at the National Cancer Institute. The company’s current market cap was around $395m as of closing today (but it closed up 30% in after-hours trading).

Full Trial Data To Be Announced June 5th

While I’m bullish on Delcath (disclosure: I own the stock), it’s important to note that the full details of this trial won’t be available until June 5th, when the lead researcher presents at the American Society of Clinical Oncology’s (ASCO) 2010 Annual Meeting.

That’s when we’ll learn about overall survival of patients, along with other important study details. So even though Delcath’s system met the primary endpoint, as they announced tonight, we don’t know exactly how long (or if) it increased overall survival among patients. The data looks good so far, but I prefer to stay wary and be ready for a surprise.

Don’t get me wrong, the ASCO meeting is a great platform to present data. If the system works, hopefully it will be in the hands of oncologists ASAP, saving and extending lives. It may be that they just need more time to process and analyze the data fully. Perfectly understandable. But the bottom line is that we don’t have all the data yet.

By the way, we alerted Wealth Daily readers to Delcath two days ago (4/19/2010). This is the kind of scoop you could be missing out on if you’re not reading our free newsletter yet. If you haven’t signed up yet, you can do so below.