09-12-05 12:30 PM EST  

WASHINGTON -(Dow Jones)- The Food and Drug Administration said Monday
that a proposed prostate cancer drug by Abbott Laboratories (ABT) isn't
effective.

The FDA released its review of the drug, Xinlay, prior to a Tuesday
meeting of outside medical experts to review it. Abbott is seeking FDA
approval of Xinlay in men with advanced prostate cancer, or cancer that
has spread to the bone.

Two clinical studies of the drug showed it failed to achieve its primary
goal of keeping the disease from progressing compared to patients not
receiving the drug in a group of patients that failed to respond to
hormone-based cancer therapies.

Abbott went back and focused on a group of patients where the cancer had
spread to the bone.

The FDA said Monday the new analysis of the drug, known generically as
atrasentan, still suggested the drug failed to hit its target. A medical
reviewer said Abbott's application for Xinlay "failed to demonstrate a
delay in disease progression for subjects in the atrasentan treatment
group compared with those in the placebo group and the observed data
does not support the sponsor's claim of efficacy of atrasentan."

The agency also said "the findings from the subgroup analyses should be
confirmed through other studies."

The FDA also noted there were more deaths among patients receiving
Xinlay than those in the placebo groups, including more cardiovascular
deaths. The agency said there were "serious cardiovascular safety
issues" associated with Xinlay.

Michael Weinstein, an analyst with JPMorgan, said in a research note
that the tone of the FDA documents suggests the FDA panel won't
recommend approval of Xinlay in the near term. Abbott is conducting
additional studies of Xinlay, which it could later submit to the FDA.
JPMorgan has an investment-banking relationship with Abbott
Laboratories.
In its briefing document prepared for Tuesday's meeting, Abbott said
Xinlay significantly reduced bone pain and cut the risk of disease
progression by 19% among those with advanced cancer. The company said
the risks of heart-failure associated with Xinlay are recognizable and
can be appropriately managed.

"Given the relative paucity of treatment options available...atrasentan,
if approved, would represent an additional effective treatment option,"
Abbott said.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com

knowledge is power - growing old is mandatory - growing wise is optional    
"Many more men die with prostate cancer than of it. Growing old is
invariably fatal. Prostate cancer is only sometimes so."
http://community.webtv.net/PALMER_ENT/doc