Abbott's new drug for prostate cancer will also take aim at pain

Chicago Tribune

By Bruce Japsen, Tribune staff reporter

September 12, 2005

The spread of prostate cancer into her husband's bones was enough of a battle, but Betty Gallo said her husband, Dean, also tried to fight debilitating pain in the last months of his life.

The congressman from New Jersey was unable to focus on his fight against cancer because disease had invaded his bones, a destination resulting in terrible pain for tens of thousands of cancer patients each year.

Gallo died in 1994 at age 58 with only a morphine drip from his hospital IV for pain and the comfort of his wife keeping him lucid. "The pain was so horrible there were times you could not touch him because he was in such agony," Betty Gallo recalls of her husband, who served 10 years in the U.S. House of Representatives. "I think you can focus more on getting the disease under control if you can control the pain."

It may be too late for Dean Gallo, but a pill developed by Abbott Laboratories hopes to address the spread of prostate cancer while delaying the onset of pain.
A Food and Drug Administration advisory panel of cancer experts will decide this week whether the drug, called Xinlay, should be recommended for approval. The FDA typically follows the recommendations of its advisory panels.

For North Chicago-based Abbott, approval could mean up to $300 million in sales next year and eventually more than $1.5 billion annually, say analysts, pointing to studies that evaluate whether it can be used to treat other cancers. Abbott believes Xinlay is a breakthrough that should merit strong consideration, especially because there are more than 2 million American men with prostate cancer. About 230,000 cases are diagnosed each year.

But the submission is unique and there are no slam-dunks, especially now that the FDA is under fire from consumer groups and lawmakers over perceived lax reviews of drug safety in the wake of Vioxx. The FDA approved Vioxx in 1999, but the drug was pulled last fall after a study showed increased risks of heart attacks and stroke. "There has been some talk that because of Vioxx that sensitivities could be heightened," says Michael Zbinovec, director of corporate finance and a pharmaceutical analyst for Fitch Ratings in Chicago.
"Clearly, [FDA and its advisory panels] are looking more closely at existing therapies, which is why you are seeing a host of new warning labels. As far as the approval of new drugs and what kind of scrutiny they will face, I think people have a wait-and-see attitude," Zbinovec said.

Analysts expect FDA advisers to take a hard look at Xinlay, especially because the drug is trying to make a comeback of sorts. In 2003, Abbott halted a key clinical trial because the drug was failing to slow progression of the disease in end-stage prostate cancer patients.
But Abbott officials described that setback as an early-stage trial. The company says it now has more complete data and will submit to the FDA more recent studies that show the drug is promising in the sickest of prostate cancer patients.

Abbott sees the pain relief feature as an added benefit to slowing the progression of the disease.  "There is a bigger effect in pain than other clinical events," said Dr. John Leonard, vice president of Abbott's global pharmaceutical development.

The two primary studies being submitted to the FDA show the drug slowed the spread of prostate cancer and delayed the onset of pain in 20 percent to 30 percent of the patients who took Xinlay. Of patients who had cancer reach their bones, the onset of pain was delayed by as long as three months.

While that does not seem like a large percentage of patients, such rates of effectiveness often merit approval because prostate cancer patients often have few, if any, other hope for treatment, analysts say.
"Even if the drug only works in one-third of patients that would be a big step because 30,000 men a year die from the disease," said Dr. Jerome Hoeksema, an assistant professor of urology at Rush University Medical Center in Chicago and immediate past president of the American Cancer Society's Illinois division. "You could have an impact on 10,000 men or more. That is a significant number of men."

Late-stage prostate cancer patients tend to be frail men who are about 70 years of age, and the next stage for most of these men is death because so few tolerate another round of treatment, such as chemotherapy, if they can handle any treatment at all.
Xinlay also is deemed important among clinicians, who say more drugs are needed for men with late-stage prostate cancer because they eventually stop responding to hormonal therapies such as Lupron, an injected drug sold by Abbott affiliate TAP Pharmaceutical Products Inc. of Lake Forest.

Abbott and some cancer doctors say FDA advisory panels look at cancer drugs differently than maintenance medications like arthritis or cholesterol pills because they can be the last hope for patients.
"When the disease progresses, we don't have a lot of active treatments and are looking for something to take us to the next level after hormone therapy loses effectiveness," Hoeksema said.

Xinlay is considered a more targeted therapy, which means it's designed to be more convenient and less toxic to the body than traditional chemotherapy.
Xinlay's side effects include runny nose, red eyes and fluid retention. "If you have a runny nose, it tends to go away," Leonard said. "Targeted therapies are the new frontier and the promise is great," Hoeksema said. "Targeted therapies offer promise of treating the malignant cells without targeting the normal tissue, so the drug goes where it needs to work without exposing the whole body. It kills the cancer cells."
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bjapsen@tribune.com