Delcath Systems (Nasdaq: DCTH ) is a specialty pharmaceutical and medical device company focused on oncological treatments.
Today, let's look at three things investors should be watching regarding Delcath Systems, as they will provide us with better insight into the company.
1. NDA filing for hepatic Chemosat therapy device with melphalan
After waiting for 24 years (no joke, 24!), it appears that Delcath shareholders finally have a reason to be excited, with the company filing a new drug application with the Food and Drug Administration that encompasses both its revolutionary hepatic Chemosat therapy device that delivers chemotherapy agents directly to the liver via hepatic artery infusion, as well as the cancer-fighting agent it purchased from GlaxoSmithKline (NYSE: GSK ) in 2003, melphalan.
Early indications are that its Chemosat device will receive priority review status, as patients with metastatic melanoma -- a type of liver cancer -- have few treatment options available to them right now. Typical chemotherapy agents are unable to target specific organs, so this device, according to Delcath CEO Eamonn Hobbs, has $500 million market potential.
Delcath's chemosaturation therapy device was first presented to the FDA in 2011, but was quickly rejected on the grounds that the FDA required more data on the sanitization of the product. Investors have every reason to be upbeat about the possibilities of Delcath's chemosaturation system as it presented a clear advantage over the control arm in phase 3 clinical trials -- more than tripling patient survival to 214 days, from 70 days.
Delcath currently has the Chemosat device approved in Europe and derived its first commercial revenue from the product in the second quarter. It also has a marketing partnership in place with Chi-Fu Trading in Taiwan, with the option for Singapore as well.
2. Improving Chemosat's indications
Another big component to Chemosat's success will be expanding its indications beyond just metastatic melanoma and into other types of liver and colon cancers, which CEO Hobbs thinks could push the company's target revenue pool in the U.S. as high as $2 billion.
Delcath currently has one ongoing clinical phase 2 trial for patients with unresectable liver cancer utilizing melphalan and targeting; hepatocellular carcinoma (primary liver cancer); metastatic adenocarcinomas; neuroendocrine tumors in the liver; and patients with metastatic ocular and cutaneous melanoma who received prior regional melphalan therapy.
Data here again suggests that Delcath's unique delivery system and melphalan do indeed work, although these results are still in the early stages and should be taken with a grain of salt. A study on metastatic neuroendocrine tumors showed that 70% of 20 patients showed a hepatic response after three treatments, whereas the normalized response rate for these patients under current treatment arms would be 5%. We'll need more concrete evidence than just 20 patients, but the data has remained encouraging despite its decades in the making.
If you think Delcath is the only hepatic artery infusion, or HAI, game in town, you have another thing coming because the competition to treat liver cancer is fierce. From an HAI perspective, there have been early stage studies run recently infusing Taxol, made by Bristol-Myers Squibb (NYSE: BMY ) , and various other generic producers, that have shown positive effects in reducing tumor proliferation – although brivanib was a miserable failure for Bristol-Myers. Johnson & Johnson (NYSE: JNJ ) subsidiary Janssen Pharmaceuticals noted recently that combining radiofrequency ablation with chemotherapy agent Doxil may reduce tumor growth in the liver.
From a non-infused standpoint, Onyx Pharmaceuticals' (Nasdaq: ONXX ) Nexavar remains the king of all liver cancer treatments. The point of the HAI is to deliver toxins to targeted organs, which Nexavar cannot do, but it's unlikely that we'll see Nexavar lose its liver cancer treatment crown anytime soon.
Now that you know what to watch for, it should be easier to analyze Delcath Systems' successes and pitfalls in the future and hopefully give you a competitive investing edge.
If you're still craving even more info on Delcath Systems, I would recommend adding the stock to your free and personalized watchlist so you can keep up on all of the latest news with the company.
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