Every year, about a quarter million cases of liver cancer are diagnosed in the United States; around the world the number is estimated to exceed two million. According to the American Cancer Society, the five-year survival rate of liver cancer is just 10.8%. This is one of the most fatal of all cancers -- prostate (98.4%), breast (88.6%), and even lung cancer (15.0%) have significantly better survival rates.
Today, surgery is the only option to cure liver cancer, and it comes in two forms: tumor removal and transplant. Completely removing the tumor is not usually possible, as the cancer is often large, in many different parts of the liver, or has spread beyond the liver. Additionally, most people with cirrhosis have too little healthy liver remaining to allow for surgery.
Transplant is no panacea, either, even though survival rates for those that do get one are about 75%, according to the American Liver Foundation. Liver transplants cost over $500,000, and few livers are available. One notable beneficiary is Apple Inc. (Nasdaq: AAPL) co-founder and CEO Steve Jobs, 54, who received a liver transplant about a year ago after suffering complications from pancreatic cancer several years earlier.
In most instances involving liver cancer, transplants are used in only select cases where there are a few small tumors that cannot be removed by surgery. There are also non-surgical treatments, including radiation and chemotherapy, neither of which cures the disease or even helps people live longer.
New treatments are obviously needed for the vast majority of cases that do not qualify for surgery.
One company has a treatment currently in Phase III FDA trials that may change the way doctors treat liver cancer. This treatment has a fast-track designation from the U.S. Food and Drug Administration (FDA), meaning that the FDA believes that it shows promise in treating a life-threatening disease that no other treatment currently addresses well.
Delcath Systems (Nasdaq: DCTH) is a $246.4 million New York-based drug developer focused on treatments for liver cancer. The company expects data from its current clinical trial available in the next month and to submit its FDA application for its first approval, a treatment for metastatic melanoma of the liver -- skin cancer that has spread to the liver -- by the middle of this year.
The treatment isolates the liver from the rest of the body by restricting blood flow. Then, a huge dose of chemotherapy, about ten times what is typically administered intravenously, is given to the liver. But since it is targeted and not spread throughout the body, the liver sees about 100 times more drugs. Blood in the liver is then removed, cleaned of the toxic drugs, and returned to the body. This delivery system allows for much more of the drugs to go where doctors want them while minimizing the amount of drugs that get exposed to the rest of the body.
While focused on the liver, the company's drug delivery technique could be more broadly used. Other organs can be isolated and treated in the same manner, and the company plans to address these in the future, either itself or through partnership deals. The company has received the go-ahead from the FDA to begin Phase III trials for its treatment on primary liver cancer, but it is currently looking for partners in Asia to do the study as it will be less expensive and easier to find patients. In February, Delcath announced an agreement with the Taiwanese company Chi-Fu Trading. The agreement gives Chi-Fu the exclusive right to market Delcath's liver treatment in Taiwan and could bring in up to $10 million for the company, assuming the treatment received the necessary approvals.
As a biotech development company, Delcath has no revenue. If the company gets its drug approved -- the ultimate profit catalyst in this industry -- an investment would likely pay off big time. In the meantime, good news in the coming month could move shares upward.
The company has said that it expects approval of its treatment for metastatic melanoma of the liver in mid-2011. At the end of 2009, the company had about $35.5 million in cash, no debt, and a burn-rate of about $1.8 million per month.
Risk-tolerant investors looking for big potential upside may consider DCTH. Keep in mind, however, that bad news from its clinical trials or from the FDA could push shares down quickly.