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Cancer That Won't Quit

Pancreatic cancer is incredibly deadly, but several firms still seek a therapy.

Too often, pancreatic cancer goes unnoticed until it's too late. For the vast majority of patients who get the diagnosis, the only treatment available is end-of-life care meant to ease their suffering.

Simply put, the prognosis for those with pancreatic cancer is bad, to say the least. Currently, surgery, radiation and chemotherapy are used to treat it, but several drug companies, from smaller biotechs like

Cell Genesys

(CEGE)

to pharmaceutical giants like

Novartis

(NVS) - Get Novartis AG Report

, are trying to find other options.

Last November, Tarceva, a drug developed by

OSI Pharmaceuticals

(OSIP)

and co-marketed with

Genentech

(DNA)

, was

approved for use with gemcitabine chemotherapy for cancer of the pancreas. Tarceva was already being marketed as a treatment for lung cancer.

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Though other, experimental pancreatic cancer drugs are in clinical trials, few of them are in phase III studies, the last stage before a product is submitted for regulatory approval. Two little-known companies,

Lorus Therapeutics

(LRP)

and

Therion Biologics

, have drugs in phase III trials.

According to the American Cancer Society, more than 33,000 Americans, a little more than half of them men, will be diagnosed with pancreatic cancer this year. At the same time, the disease will kill an estimated 32,300 patients in the U.S. this year, making pancreatic cancer the fourth-leading cause of cancer death. Worldwide, it takes more than 200,000 lives a year.

Clear Need

Considering numbers like that, it's hardly a surprise that numerous firms would be chasing a viable treatment. But as with medications for any disease, success is often elusive.

The Web site Pancreatica.org says the median length of survival from the time of diagnosis until death "is arguably the worst of any of the cancers." For advanced pancreatic cancer that isn't treated, the median survival is about three and a half months. Good treatment can increase survival to around six months, the Web site says. Pancreatica.org is maintained by the Lorenzen Cancer Foundation, a California nonprofit.

The symptoms of pancreatic cancer tend to be stomach pain, weight loss, fatigue and yellowing of the skin. Many mimic those of other, far less serious illnesses. Early symptoms, if they actually appear, are difficult to attribute to cancer of the pancreas, but those are followed by more severe signs, such as chronic pain, vomiting and trouble absorbing food.

The pancreas is a small organ about 6 inches long that's located behind the stomach. It's responsible for regulating blood-sugar levels and producing juices that break down food.

Only about 24% of patients with cancer in what's called the exocrine part of the pancreas will be alive a year after their diagnosis. About 5% will live five years. Even for people diagnosed with pancreatic cancer that hasn't spread, the five-year relative survival rate is only 16%, the American Cancer Society says.

One of the companies that's taken a product to phase III is Lorus, a tiny biotech outfit based in Toronto with a market capitalization of $55 million. Lorus is researching a drug called Virulizin. Results released last October showed the drug didn't significantly extend the survival of patients when it was used with gemcitabine chemotherapy in patients with advanced pancreatic cancer that had spread.

Positive results were found in certain subgroups of patients, but the data may not prove to be enough for regulatory approval without further trial data.

Meanwhile, Therion's drug Panvac-VF is being tested in patients who haven't responded to gemcitabine chemotherapy.

Then there's Switzerland's Roche, which has its own drug, Xeloda, in phase III trials. The data that have been reviewed found that Xeloda plus chemotherapy significantly extended the length of patient survival. One out of four trial patients was still alive after a year when treated with Xeloda plus chemotherapy, while one in five lived for a year on chemo alone.

Xeloda is currently approved by the FDA for breast cancer and as a treatment after surgery for colon cancer. Roche has also initiated trials using Xeloda and Genentech's Avastin. Genentech is majority-owned by Roche.

Hard to Advance

Several other proposed treatments, often developed by small companies, are lingering in earlier trials, and some have gotten stuck there.

GlobeImmune

has a drug, GI-4000, in phase II clinical trials. Toronto-based

YM BioSciences

(YMI)

and its German partner

Oncoscience AG

have their drug, called nimotuzumab, in phase II trials.

Immunogen

(IMGN) - Get ImmunoGen, Inc. Report

is also working on a pancreatic cancer treatment.

Cell Genesys has designed a vaccine, called GVAX, for pancreatic cancer to improve patient survival when added to current treatments. Phase II trials of the drug are ongoing.

GenVec

(GNVC)

also has a drug called TNFerade in phase II studies.

At the other end of the scale with experimental pancreatic cancer drugs are companies like

Pfizer

(PFE) - Get Pfizer Inc. Report

and Europe's

Schering AG

(SHR)

and Novartis.

For the small companies, who don't have the research budgets of drug giants, there might be only one shot to make a medicine that works. Early last year

Supergen

(SUPG)

withdrew its new drug application for Orathecin for pancreatic cancer, saying feedback from the FDA indicated that its data wasn't sufficient for approval.

In a worst-case scenario, a company potentially could be facing hard questions about its continued existence. Early in February, one developer of a pancreatic cancer treatment,

GlycoGenesys

(GLGS)

, said it laid off half its staff and filed for bankruptcy protection in an attempt to save the business.