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发帖数: 5997 | 1 This Small Biotech Firm's Shares Could Rocket in the Next 30 Days
By: Anthony Haddad
Staff Writer
StreetAuthority
Published: March 26, 2010
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. | b**********e
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